Evaluation of Safety and Efficacy of the S.M.A.R.T. RADIANZ™ Vascular Stent System in the Treatment of Iliac and Femoropopliteal Lesions Via Transradial Access
Phase: NA
Conditions: Peripheral Arterial Disease
Sponsor: Cordis US Corp.

RADIANCY / P21-7701 
Version: 7.0 / March 21, 2023
CORDIS USE:
The information in this document is the property of Cordis US Corp. and is CONFIDENTIAL and 
PROPRIETARY. Neither the document nor the information contained therein may be reproduced or 
disclosed outside Cordis US Corp. without the written consent of the company.
CONFIDENTIAL 
Page 1 of 83 
FINAL 
Clinical Study Protocol
System in the Treatment of Iliac and Femoropopliteal Lesions via Transradial Access
RADIANCY
Product Names:
S.M.A.R.T. RADIANZ
Vascular Stent System
BRITE TIP RADIANZTM Guiding Sheath
SABERX RADIANZTM PTA Balloon Catheter
Protocol Number:
P21-7701
CIV-ID Number:
CIV-22-02-039027
Version: 
 7.0
Version Date:
March 21, 2023
Cordis US Corp.
 14201 NW 60th Ave
 Miami Lakes, FL 33014
Cordis Cashel
 Cahir Road, Cashel
 County Tipperary, Ireland
TO CONTACT THE SPONSOR REGARDING SAFETY MATTERS:
The Medical Monitor and other members of the study team (
can 
be reached using the Study Contact List provided by the sponsor.
Version History
Version Number
Version Date
Summary of Revisions
1.0
December 22, 2021
N/A (original version)
2.0
February 15, 2022
Added/clarified/reorganized content within Safety Reporting section,
clarified medication regimen, added anticipated study start/end dates
3.0
April 25, 2022
Added/changed content to Study Design section (with clarifications on 
the
-
), Subject Early Discontinuation section and 
Statistics/Data Analyses section (including removal of interim 
analysis), minor clarifications in Products and Screen Failures sections
NCT number
NCT05399680

RADIANCY / P21-7701                                       
 
 
 
                      
Version: 7.0 / March 21, 2023              
CONFIDENTIAL 
Page 2 of 83  
FINAL 
 
 
                
 
 
4.0
June 02, 2022
Increased total sample size, clarified primary safety endpoint, updated 
Statistics/Data Analyses section with revisions to assumed technical 
success and safety rates and addition of performance goals; updated 
number of sites and countries
5.0
June 09, 2022
Minor clarifications/additions to numerous sections (Background, 
Risks, Inclusion Criteria, Informed Consent, Safety Reporting, Quality 
Control/Quality Assurance, Record Retention, Participating Sites),
additions to Appendix B
6.0
July 29, 2022
Addition of lead (coordinating) Investigator, SMART RADIANZ 
risk/anticipated AE occurrence corrections, rearrangement of 
secondary safety endpoints and inclusion/exclusion criteria for clarity,
addition of Overall Process section (10.1), minor 
clarifications/additions/corrections in Screening/Enrollment, Reporting, 
Data Quality Assurance and Monitoring sections.
7.0
March 21, 2023
Change of CRO (entity performing medical monitor, monitoring and 
safety management roles); r
-
assessments; modifications to endpoints; modifications to
inclusion/exclusion criteria and bilateral stenosis treatment; inclusion 
of additional radial duplex ultrasound; addition of Risk/Benefit Analysis 
and Risk Management sections (5.4 & 5.5), clarifications to 
telephone/virtual follow-up, updates/additions to Participating 
Investigators and Sites

RADIANCY / P21-7701                                       
 
 
 
                      
Version: 7.0 / March 21, 2023              
CONFIDENTIAL 
Page 3 of 83  
FINAL 
 
 
                
 
 
in the Treatment of Iliac and Femoropopliteal Lesions via Transradial Access
RADIANCY
Protocol Number: P21-7701
Version: 7.0
Version Date: March 21, 2023
Approval Signatures
I am the primary author of this study protocol and confirm, to the best of my knowledge, that it is complete 
and accurate.
Name 
Role 
Signature 
Date 
Rajesh Nathan
Clinical Project Manager 
 
 
I have reviewed the study protocol and confirm, to the best of my knowledge, that it is complete and 
accurate.
Nusrath Sultana, MD, MBA
Clinical Management
 
 
 
Nusrath Sultana, MD, MBA
Medical Monitor 
 
 
Steven Ullery
Statistician
(NAMSA) 
 
 
Linda Ruedy
Regulatory Affairs 
 
 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
           
CONFIDENTIAL 
Page 4 of 83 
FINAL  
 
in the Treatment of Iliac and Femoropopliteal Lesions via Transradial Access
RADIANCY
Protocol Number: P21-7701
Version: 7.0
Version Date: March 21, 2023
Investigator Protocol Signature Page
I have read this protocol and agree that it contains all necessary details for carrying out this study.  I will 
conduct the study in accordance with the design and specific provisions outlined herein.
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who 
assist in the conduct of this study.  I will discuss this material with them to ensure they are fully informed 
regarding the investigational product and the conduct of the study.
I will use the informed consent form approved by Cordis US Corp. or its designee and the Ethics Committee 
(EC) and will fulfill all responsibilities for submitting pertinent information to the EC responsible for this study.
I also agree to report all information or data in accordance with the protocol and, in particular, I agree to 
report all adverse events, device deficiencies, and complaints, as defined in the protocol.
I further agree that sponsor and/or designee have access to any original source documents from which 
case report form (CRF) information may have been generated.
I also agree to have control over all clinical supplies (including all product) provided by sponsor and/or 
designees and collect and handle all clinical specimens in accordance with the protocol.
The below signed confirm herewith to have read and understood this study protocol and/or amendment and 
appendices; furthermore, to accomplish this study in accordance with the protocol, ICH/GCP guidelines, 
applicable international standards and all applicable country, local and federal regulations; and to accept 
respective revisions conducted by authorized personnel of sponsor and by regulatory authorities.
Principal Investigator
(print)
Principal Investigator
(signature)
Date
Institution Name/Location

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
           
CONFIDENTIAL 
Page 5 of 83 
FINAL  
 
Table of Contents
Approval Signatures ................................................................................................................ 3 
Investigator Protocol Signature Page ..................................................................................... 4 
Table of Contents ..................................................................................................................... 5 
Protocol Synopsis .................................................................................................................. 10 
Time and Event Schedule ...................................................................................................... 16 
Study Management Team ...................................................................................................... 17 
1 
Introduction ................................................................................................................. 18 
1.1 
Background.................................................................................................................................... 18 
1.2 
RADIANCY Clinical Study ............................................................................................................. 18 
1.3 
Literature Reviews......................................................................................................................... 19 
1.3.1 Literature Review Related to S.M.A.R.T. RADIANZ and Similar Devices........................... 19 
1.3.2 Literature Review Related to SABERX RADIANZ and Similar Devices.............................. 20 
2 
Products ...................................................................................................................... 20 
2.1 
Investigational Products ................................................................................................................ 20 
2.1.1 S.M.A.R.T. RADIANZ .......................................................................................................... 20 
2.1.2 SABERX RADIANZ: 9 and 10 mm Diameters..................................................................... 21 
2.2 
CE Marked Products ..................................................................................................................... 22 
2.2.1 BRITE TIP RADIANZ........................................................................................................... 22 
2.2.2 SABERX RADIANZ: 2 through 8 mm Diameters................................................................. 22 
3 
Study Objectives......................................................................................................... 23 
4 
Indications................................................................................................................... 24 
4.1 
Investigational Products ................................................................................................................ 24 
4.1.1 S.M.A.R.T. RADIANZ .......................................................................................................... 24 
4.1.2 SABERX RADIANZ: 9 and 10 mm Diameters..................................................................... 24 
4.2 
CE Marked Products ..................................................................................................................... 24 
4.2.1 BRITE TIP RADIANZ........................................................................................................... 24 
4.2.2 SABERX RADIANZ: 2 through 8 mm Diameters................................................................. 24 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
           
CONFIDENTIAL 
Page 6 of 83 
FINAL  
 
5 
Benefits/Risks ............................................................................................................. 24 
5.1 
S.M.A.R.T. RADIANZ .................................................................................................................... 24 
5.1.1 Benefits ................................................................................................................................ 24 
5.1.2 Risks .................................................................................................................................... 25 
5.2 
BRITE TIP RADIANZ..................................................................................................................... 26 
5.2.1 Benefits ................................................................................................................................ 26 
5.2.2 Risks .................................................................................................................................... 26 
5.3 
SABERX RADIANZ ....................................................................................................................... 27 
5.3.1 Benefits ................................................................................................................................ 27 
5.3.2 Risks .................................................................................................................................... 27 
5.4 
Benefit and Risk Assessment........................................................................................................ 28 
5.4.1 Benefits ................................................................................................................................ 28 
5.4.2 Risks .................................................................................................................................... 29 
5.4.3 Summary of Assessment..................................................................................................... 29 
6 
Study Design ............................................................................................................... 30 
7 
Inclusion and Exclusion Criteria ............................................................................... 31 
7.1 
Inclusion Criteria............................................................................................................................ 31 
7.2 
Exclusion Criteria........................................................................................................................... 32 
8 
Study Endpoints ......................................................................................................... 33 
8.1 
Primary Endpoints ......................................................................................................................... 33 
8.1.1 Primary Safety Endpoint ...................................................................................................... 33 
8.1.2 Primary Efficacy Endpoint.................................................................................................... 33 
8.2 
Secondary Endpoints .................................................................................................................... 34 
8.2.1 Secondary Safety Endpoints ............................................................................................... 34 
8.2.2 Secondary Efficacy Endpoints............................................................................................. 34 
8.3 
Additional Data Points ................................................................................................................... 34 
8.4 
Rationale for Study Endpoints....................................................................................................... 34 
9 
Informed Consent ....................................................................................................... 35 
10 
Screening and Enrollment ......................................................................................... 36 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
           
CONFIDENTIAL 
Page 7 of 83 
FINAL  
 
10.1 Overall Process ............................................................................................................................. 36 
10.2 Pre-Screening and Screening ....................................................................................................... 37 
10.2.1 
Data Collection and Assessments................................................................................. 37 
10.2.2 
Screen Failures & Pre-Screen Failures......................................................................... 37 
10.2.3 
Duration ......................................................................................................................... 38 
10.3 Enrollment...................................................................................................................................... 38 
11 
Treatment Plan ............................................................................................................ 38 
11.1 Index Procedure ............................................................................................................................ 38 
11.2 Treatment of Bilateral Stenosis ..................................................................................................... 40 
11.3 Treatment Failures ........................................................................................................................ 40 
11.4 Post-Procedure Care/Discharge (+7 days) ................................................................................... 41 
11.5 Recommended Medication Regimen ............................................................................................ 42 
11.6 Follow-up Visit/Assessments......................................................................................................... 42 
11.7 Telephone/Virtual Follow-Up ......................................................................................................... 42 
11.8 Lost to Follow-up ........................................................................................................................... 43 
11.9 Unscheduled Visits ........................................................................................................................ 43 
11.10 Subject Study Exit/Discontinuation................................................................................................ 43 
11.11 End of Study .................................................................................................................................. 44 
12 
Core Laboratory .......................................................................................................... 44 
13 
Safety Reporting ......................................................................................................... 44 
13.1 Adverse Events ............................................................................................................................. 44 
13.2 Anticipated Adverse Events........................................................................................................... 47 
13.3 Serious Adverse Events ................................................................................................................ 49 
13.4 Major Adverse Events ................................................................................................................... 49 
13.5 Unanticipated Serious Adverse Device Effects ............................................................................. 50 
13.6 Device Deficiencies ....................................................................................................................... 50 
13.7 Complaints for CE Marked Product............................................................................................... 51 
13.8 Reportable Events ......................................................................................................................... 51 
13.8.1 
Investigational Product .................................................................................................. 51 
13.8.2 
CE Marked Product ....................................................................................................... 52 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
           
CONFIDENTIAL 
Page 8 of 83 
FINAL  
 
13.9 Post-Market Surveillance and Vigilance........................................................................................ 52 
13.9.1 
Reporting Serious Incidents and Field Safety Corrective Actions................................. 52 
13.9.2 
Trend Reporting............................................................................................................. 53 
13.9.3 
Analysis of Serious Incidents and Field Safety Corrective Actions ............................... 53 
13.10 Risk Assessment and Management.............................................................................................. 53 
14 
Statistics/Data Analyses ............................................................................................ 54 
14.1 Analysis Population ....................................................................................................................... 54 
14.2 Statistical Hypotheses for Endpoints............................................................................................. 55 
14.3 Sample Size Determination........................................................................................................... 55 
14.4 Statistical Analysis Methods.......................................................................................................... 56 
14.4.1 
Primary Analysis............................................................................................................ 56 
14.4.2 
Additional Analyses ....................................................................................................... 57 
14.5 Missing Data.................................................................................................................................. 57 
14.6 Reporting ....................................................................................................................................... 58 
15 
Quality Control and Quality Assurance .................................................................... 58 
15.1 Regulatory and Ethical Compliance .............................................................................................. 58 
15.2 Data Quality Assurance................................................................................................................. 58 
15.3 Clinical Data................................................................................................................................... 59 
15.4 Monitoring...................................................................................................................................... 60 
15.5 Protocol Modifications ................................................................................................................... 61 
15.5.1 
Protocol Amendments ................................................................................................... 61 
15.5.2 
Protocol Deviations/Noncompliance.............................................................................. 61 
15.5.3 
Emergency Deviations................................................................................................... 61 
15.6 Audits............................................................................................................................................. 61 
15.7 Subject Confidentiality and Data Privacy ...................................................................................... 62 
15.8 Ethics Committee (EC) .................................................................................................................. 62 
16 
Record Keeping/Publication Policy ........................................................................... 63 
16.1 Record Retention........................................................................................................................... 63 
16.2 Use of Information and Publications.............................................................................................. 63 
17 
Product Accountability ............................................................................................... 63 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
           
CONFIDENTIAL 
Page 9 of 83 
FINAL  
 
17.1 Product Accountability ................................................................................................................... 63 
17.2 Instructions for Return of Investigational Products........................................................................ 64 
18 
Committees ................................................................................................................. 64 
18.1 Data and Safety Monitoring Board ................................................................................................ 64 
18.2 Clinical Events Committee............................................................................................................. 65 
18.3 Early Study Termination or Suspension ........................................................................................ 65 
19 
Bibliography ................................................................................................................ 66 
Appendix A. 
Definitions ..................................................................................................... 75 
Appendix B. 
Acronyms and Abbreviations ...................................................................... 79 
Appendix C. 
Participating Investigators and Sites .......................................................... 81 
Appendix D. 
EASY Hematoma Classification System ..................................................... 83 
 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 10 of 83 
FINAL  
 
in the Treatment of Iliac and Femoropopliteal Lesions via Transradial Access
RADIANCY
Protocol Number: P21-7701
Version Date: March 21, 2023
Protocol Synopsis
Protocol Title
Stent System in the Treatment of Iliac and Femoropopliteal Lesions via 
Transradial Access
Abbreviated Title
RADIANCY
Name of Sponsor
Cordis US Corp.
Products
S.M.A.R.T. RADIANZ
Vascular Stent System (investigational)
BRITE TIP RADIANZTM Guiding Sheath (CE marked)
SABERX RADIANZTM PTA Balloon Catheter (investigational for 9 and 10 mm 
diameters; CE marked for 2 through 8 mm diameters)
Reference/Control Treatment N/A
Intended Use
BRITE TIP RADIANZTM Guiding Sheath and SABERX RADIANZTM PTA 
Balloon Catheter, is intended for treatment of lesions in the iliac, superficial 
femoral or proximal popliteal arteries via radial artery access.
Study Purpose
The primary objective of this clinical investigation is to evaluate acute safety 
used with the BRITE TIP RADIANZTM Guiding Sheath and SABERX 
RADIANZTM PTA Balloon Catheter, to deploy the S.M.A.R.T.TM Nitinol Stent,
in the treatment of patients with obstructive iliac or femoropopliteal arterial 
disease via radial artery access.
Study Design
Multi-center, single-arm, non-randomized, prospective, pivotal (pre-market) 
clinical study
Study Centers
Approximately 15 investigational sites across Europe
Timeline
Actual start (first subject enrollment): Q2 2022
Anticipated completion (last subject last visit): Q4 2023
Primary Endpoints
Primary Safety Endpoint:
Occurrence rate of CEC-adjudicated, major radial access site 
complications attributed to study device or procedure
through time of 
hospital discharge.
Primary Efficacy Endpoint:
Technical success at the conclusion of the index procedure, defined as 
into the peripheral vasculature through the radial artery, successful 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 11 of 83 
FINAL  
 
deployment of the study device (S.M.A.R.T.TM stent) at the intended location, 
and successful withdrawal of the delivery system without conversion from 
radial to femoral artery access.
Secondary Endpoints
Secondary Safety Endpoints:
Peri-procedural (within 30 days post-index procedure):
o
Rate of device deficiencies for each of the three (3) devices
o
Rate of adverse events
o
Rates of death, index limb amputation and target lesion 
revascularization
o
Rate of procedural complications
Secondary Efficacy Endpoints:    
Technical success associated with use of the BRITE TIP RADIANZTM
Guiding Sheath, defined as successful insertion of the device into the 
peripheral vasculature through the radial artery (allowing for introduction 
of interventional and/or diagnostic devices) and successful withdrawal of 
the device.
Procedural success associated with use of the SABERX RADIANZTM
PTA Balloon Catheter for pre-dilation and/or post-deployment stent 
dilatation (whenever applicable), defined as successful insertion of the 
device into the peripheral vasculature through the radial artery, 
successful inflation and deflation of the balloon, successful withdrawal of 
the device, and achievement of a final residual diameter stenosis of < 
30% at the conclusion of the index procedure.
Additional Data Points
Data will be collected to evaluate the following health economics 
outcomes:
o
Fluoroscopy time and procedural time, defined as the time of sheath 
introduction to time of vascular closure
o
Time to achieve hemostasis, defined as the time elapsed from 
removal of the BRITE TIP RADIANZTM Guiding Sheath to the time 
that hemostasis was first observed
o
Time to ambulation, defined as when the subject can stand up and 
walk any distance 
o
Time to hospital discharge
o
Time to hospital discharge eligibility (when physician examines and 
if all is well, gives discharge orders).
o
Method to achieve closure of the transradial artery access site
Quality of Life Assessments: Data will be also collected to evaluate 
health-related, quality of life in all subjects by administering both the SF-
36 and the EuroQOL-5 Dimension (EQ-5D) standardized, validated 
questionnaires to assess general and disease-specific outcomes.
Sample Size
This study is planned to enroll approximately 159 subjects, of which 
approximately 30 subjects will constitute the roll-in cohort for the study and 
consist of the first two (2) enrolled subjects at each study site, as applicable
To adequately assess the efficacy and safety of both iliac and 
femoropopliteal artery treatment under study, a minimum of 30 subjects will 
be required for each of the two indications (femoropopliteal and iliac).  

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 12 of 83 
FINAL  
 
A goal of this study is to collect data on 30 uses of the SABERX device.  
Ideally those uses will be evenly distributed across the iliac and 
femoropopliteal arteries.
Treatment Plan
All enrolled subjects will be followed up to 30 days post-procedure.  
A patient with bilateral stenosis (lesions in both limbs) can have both lesions 
treated without a waiting period (e.g., during the index procedure). In all 
cases, a lesion on the second/contralateral limb can ONLY be treated with 
the study devices, via transradial approach and if it meets all applicable study 
eligibility criteria.
Eligibility Criteria
Inclusion Criteria
ALL patients must meet the following criteria prior to enrollment:
1.
Age 
18 years
2.
For women of child-bearing potential, a negative pregnancy test within 
seven (7) days prior to the index procedure
3.
Symptomatic leg ischemia or ischemic ulcerations that do NOT exceed 
digits of the foot (Rutherford/Becker Classification category 2, 3, 4 or 5)
4.
Palpable radial artery with diameter 
, as assessed by duplex 
ultrasound
5.
Eligibility for standard surgical repair, if necessary
6.
A patient who requires a coronary intervention should have it performed 
at least seven (7) days prior to treatment of the target lesion
7.
The patient must provide documented informed consent and any other 
documented authorization, as required, prior to initiation of the study 
procedure
8.
Per Investigator assessment, the patient is willing and able to be 
followed up to 30 days post-procedure for evaluation and complete all 
required assessments per the study protocol.
Inclusion criteria 9 and 10 AND 11a through 14a OR 11b through 16b 
(whichever is applicable) would be assessed via baseline angiography 
performed at the time of index procedure:
9.
The Investigator has assessed that the patient is a suitable candidate 
(i.e, meets all inclusion criteria and none of the exclusion criteria), for 
treatment of a lesion in the iliac, superficial femoral and/or proximal 
popliteal arteries via transradial approach and is eligible for conversion 
from a transradial to transfemoral approach, if it becomes necessary.
10. The guidewire is across the target lesion(s) and located intraluminally 
within the distal vessel following a transradial approach
Patients whose target lesion is in the iliac artery must meet these 
additional criteria prior to enrollment:
11a. A single de novo
and/or external iliac artery
12a. Stenotic lesion (one long or multiple serial/tandem lesions) 
100 mm, 
by visual assessment, within or across the common or external iliac 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 13 of 83 
FINAL  
 
arteries.  The stenosis must be treatable with no more than two stents 
(while minimizing stent overlap)  
13a. Reference vessel diameter (RVD) ranging from 4.0 to 9.0 mm by visual 
assessment
14a. Angiographic evidence of a patent profunda or superficial femoral artery 
in the diseased (target) limb
Patients whose target lesion is in the SFA and/or PPA must meet these 
additional criteria prior to enrollment:
11b.  A single de novo or restenotic lesion 
50% stenosis in the SFA and/or 
PPA
12b.  Stenotic lesion (one long or multiple serial/tandem lesions) 
150 mm, 
by visual assessment, within or across the SFA and/or PPA.  The 
stenosis must be treatable with no more than two stents (while 
minimizing stent overlap) 
13b. RVD ranging from 4.0 to 7.0 mm by visual assessment
14b. All lesions are to be located at least three centimeters proximal to the 
superior edge of the patella
15b. Patent infrapopliteal artery, i.e., single vessel runoff or better with 
patency (<50% stenosis) of at least one of three vessels to the ankle or 
foot
16b. Adequate
stenosis after PTA or stenting) prior to treatment of the target lesion
(defined as < 30% stenosis after PTA or stenting) prior to treatment of 
the target lesion
Exclusion Criteria
Patients will be excluded if ANY of the following exclusion criteria 
apply:
1.
The patient has had/experienced any prior intervention/treatment to 
the target vessel within 90 days prior to enrollment (e.g., previously 
implanted graft in the aorta or target vessel; stroke; cryoplasty, laser 
or atherectomy; abdominal aortic aneurysm or aneurysm of the iliac, 
superficial femoral or popliteal artery). 
2.
Previously deployed stent at the site of the target lesion
3.
The patient has post-surgical stenosis and anastomotic suture 
treatments of the target vessel
4.
Requires general anesthesia for percutaneous transluminal 
angioplasty (PTA) and/or the stenting procedure
5.
Use of mechanical devices on or thrombolysis of the target vessel 
within 72 hours prior to the index procedure without complete 
resolution of the thrombus
6.
The patient is receiving any form of dialysis.
7.
The patient is receiving any form of immunosuppressant therapy.
8.
Planned amputation

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 14 of 83 
FINAL  
 
9.
Established vasospastic disease
10.
Glomerular filtration rate (GFR) < 30 mL/min within 7 days prior to the 
index procedure
11.
The patient has a history of neutropenia, coagulopathy, and/or 
thrombocytopenia.
12.
Thrombophlebitis, uremia, or deep venous thrombus, within past 30 
days prior to the index procedure
13.
Bleeding diathesis
14.
Known allergies or intolerance to antiplatelet, anticoagulant or 
thrombolytic medications including but not limited to aspirin, 
clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®) or heparin that 
cannot be medically managed.
15.
Known allergy or intolerance to Nitinol (nickel titanium)
16.
Known allergy to contrast agent that cannot be medically managed 
before treatment with steroids and/or antihistamines.
17.
Known or suspected active infection at the time of the index 
procedure.
18.
Patient is currently participating in another investigational drug or 
medical device study that has not completed primary endpoint(s) 
evaluation or clinically interferes with the endpoints from this study or 
is planning to participate in such a study prior to their completion of this 
study.
19.
Patient has had a major surgical or interventional procedure unrelated 
to this study within 30 days prior to enrollment or is anticipated/planned 
to have such a procedure within 30 days after enrollment. 
Exclusion criteria 20 through 25 would be assessed via baseline 
angiography performed at the time of index procedure:
20.
Significant vessel tortuosity or other parameters prohibiting access to 
the lesion or 90° tortuosity which would prevent delivery of the stent 
device
21.
Noted perforation of the target vessel
22.
Stent placement required across or within 0.5 cm of the 
SFA/profunda femoris artery (PFA) bifurcation
23.
Cases of chronic total occlusion/in-stent restenosis/severe 
calcification in which there is pre-determined inability to treat the 
target lesion with a single stent, or procedures pre-determined to 
require stent-in-stent placement to obtain patency
24.
Presence of thrombus prior to crossing the lesion
25.
Successful PTA treatment of a target lesion in the SFA/PPA (defined 
as < 50% stenosis after PTA treatment)

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 15 of 83 
FINAL  
 
Statistics/Testing Methods
Approximately 129 of the 159 enrolled subjects will be studied to 
Vascular Stent System for delivery of the S.M.A.R.T.TM stent to obstructive 
iliac or femoropopliteal lesions by radial artery access.  The remaining
subgroup of approximately 30 subjects, consisting of the first two (2) enrolled 
subjects at each study site (as applicable) will constitute the roll-in cohort 
for the study.  Such subjects will be pre-specified as 
-
subjects prior to 
their enrollment and must meet all criteria for enrollment, however, they will 
be followed up and evaluated to 30 days post-procedure only for safety and 
not included in any endpoint analyses.
The intent of including a 
-
cohort is to enable less experienced investigators to overcome the learning 
curve in performing the study procedure and for all investigators to become 
better accustomed to the use of the various study devices.
It is assumed that the technical success rate will be 98% and this rate will be 
compared to a performance goal of 93% which is derived from literature.  The 
testing will be done using exact methods.  A sample size of 129 limbs will 
provide 88% power to demonstrate that the observed technical success rate 
is greater than the performance goal of 93% at the 0.05 level of significance.
The assumed complication rate associated with radial access is 2.0% as 
reported in the literature.  This rate has been reported as being less than that 
associated with femoral access.  The performance goal is set at 7.0% and 
the Type I error rate is set to 5%.  Testing again is done using exact methods. 
A sample size of 129 subjects provides 88% power to demonstrate that the 
observed complication rate associated with radial access is less than the 
performance goal of 7.0%.   
To adequately assess the efficacy
and safety of both iliac and 
femoropopliteal artery treatment under study, a minimum of 30 subjects will 
be required for each of the two indications (femoropopliteal and iliac).
In order to characterize the safety and efficacy of the SABERX RADIANZ 
device, it is a goal of this study to collect information on 30 distinct uses of 
the device.  This is a goal and not a minimum since use of the SABERX 
RADIANZ device is dictated by the attending physician.  Ideally, the 30 uses 
will be evenly distributed between the iliac and femoropopliteal arteries.
Data will be collected on occurrence rate of complications associated with 
transradial artery access, successful index procedure, which is defined as 
successful insertion of the delivery system through the vasculature, 
successful deployment of the study device at the intended location, and 
successful withdrawal of the delivery system without conversion to femoral 
access. Additional secondary endpoints will report on device deficiencies,
adverse events, rates of death, index limb amputation, target lesion 
revascularization, rate of procedural complications, health economics 
outcomes, and demographic characteristics.  
For continuous variables, the mean, median, standard deviation, interquartile 
range, number of observations, minimum and maximum values, and 95% 
confidence intervals (CI), as appropriate, will be presented. For categorical 
variables, the numerator, denominator, rate (%) and exact 95% CI will be 
calculated. Data distribution will be tested, and correlations between 
variables will be explored. Additional subgroup analyses will be conducted 
and reported on. All calculations will be conducted using SAS version 9.4. 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 16 of 85 
FINAL  
 
Time and Event Schedule
All required assessments from screening to 30 days post-procedure are presented in Table 1.  
Table 1: Time and Event Schedule
1Documented informed consent must be obtained within 60 days prior to the index procedure.  The reflection period 
(time between explaining the study/providing written information to the prospective subject and obtaining documented 
consent) can vary based on individual circumstances but should be at least 24 hours in duration or per standard practice 
or institutional policies at each site.
2Must be completed within seven (7) days prior to the index procedure
3Post-procedure duplex ultrasound can be completed any time between discharge and the 30-day follow-up 
visit per standard practice.  If not standard-of-care at the site, this assessment must be completed at discharge.
Assessment
Screening
Index
Procedure
Discharge
(+7 days)
30 days (+/- 7
days) Post-
Procedure
Informed Consent1
X
Medical History 
X
Physical Examination2
X
Inclusion/Exclusion Criteria Verification
X
X
Labs2
X
Duplex Ultrasound of the radial access artery
X2
X3 (see footnote)
Angiogram
X
Adverse Event Assessment
X
X
X
Concomitant Medication
X
X
X
X
Quality of Life (SF-36 and EQ-5D) Assessments
X2
X
X

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 17 of 83 
FINAL  
 
Study Management Team
The entities that will be responsible for managing various aspects of this study are presented in Table 2.
Please refer to the Study Contact List provided by the sponsor for more specific contact information for
each of these entities, which will be updated throughout the study as needed.
Table 2: Study Management Team
Sponsor
Cordis US Corp.
Sponsor
Cordis Cashel
Medical Monitor 
North American Science Associates, LLC 
(NAMSA)
Lead (Coordinating) Investigator
Prof. Raphael Coscas
Imaging Core Laboratory 
NAMSA
Monitoring
NAMSA
Electronic Data Capture (EDC) 
System/Study Database
Medrio
Data Management
Cordis US Corp.
Safety Management
NAMSA
Statistics
NAMSA
Medical Writing
Cordis US Corp.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 18 of 83 
FINAL  
 
1
Introduction
1.1
Background
Peripheral arterial disease (PAD) affects more than 41 million people throughout the United States and 
Western Europe.1 Disabilities from PAD continue to increase each year with growing prevalence of risk 
factors, including but not limited to: tobacco use, diabetes, hypertension, and hypercholesterolemia.2
Although medical control of modifiable risk factors, and adherence to a structured regimen, are widely 
accepted as first-line treatment to slow disease progression, the majority of patients with critical limb 
ischemia require endovascular or surgical revascularization to prevent limb loss.2 Many patients with PAD 
are high-risk surgical candidates, and endovascular intervention has increasingly become the first line of 
therapy for the invasive management of PAD.2
Traditionally, the majority (approximately 97%) of endovascular interventions throughout the body have 
been performed through transfemoral arterial (TFA) access, to accommodate larger diameter or large bore 
devices for various interventions, however, TFA access is difficult to perform for patients that are morbidly 
obese and unable-to-lie-flat patients with hostile groin anatomy (e.g. multiple diffuse lesions, chronic limb 
ischemia) and history of aortoiliac occlusive disease (e.g., multiple diffuse lesions, chronic limb ischemia).1,3
TFA access is associated with increased risk of vascular complications and mortality.3
For interventions that do not have significant size requirements, alternative approaches including the 
transradial arterial (TRA) access have been extensively studied.1 It has been well established that the TRA 
compared to the TFA approach may reduce access site complications and serious adverse events, 
including mortality.4 Radial access approach is performed mostly from the left side as it is easier to 
approach target vessels due to shorter distance and since the aortic arch and cerebral vessels are avoided 
when inserting a guidewire or sheath.3 Safety and performance data on this approach is sparse due to lack 
of devices. 
The examination time for a procedure involving TRA access is similar to that for a procedure involving the 
TFA approach.
1.2
RADIANCY Clinical Study
In this clinical study, Cordis is evaluating the safety and e
Stent System (S.M.A.R.T. RADIANZ), when used with the BRITE TIP RADIANZTM Guiding Sheath (BRITE 
TIP RADIANZ) and SABERX RADIANZTM PTA Balloon Catheter (SABERX RADIANZ) to deploy the 
S.M.A.R.T.TM Nitinol Stent (S.M.A.R.T. stent) for the treatment of patients with iliac and/or femoropopliteal 
[which includes the superficial femoral artery (SFA) and proximal popliteal artery (PPA)] lesions via 
transradial artery access.
All S.M.A.R.T. RADIANZ products and all SABERX RADIANZ products in 9 and 10 mm diameters
are not CE marked (hereafter referred to as 
.
All other sizes (in 8 mm and smaller diameters) of the SABERX RADIANZ product and all BRITE 
TIP RADIANZ product are CE marked.
Both the investigational and CE marked products that will be used in this study are currently NOT 
commercially available in Europe and are being made available exclusively for use in this clinical study.  
Individually or collectively, both investigational and CE marked products

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 19 of 83 
FINAL  
 
The investigational study population is representative of the target population, which includes the following:
individuals requiring treatment for atherosclerotic lesions in the SFA and/or PPA
individuals requiring treatment in the common and external iliac arteries to improve luminal 
diameters in patients with symptomatic vascular stenotic and/or occlusive disease.
The target population is based on the 
s.
A list of all Investigators and sites (institutions) selected for participation in this clinical study is presented 
in Appendix C.
1.3
Literature Reviews
Summaries of the literature reviews that are related to the two (2) investigational products in this study 
(S.M.A.R.T. RADIANZ and 9 and 10 mm diameters of SABERX RADIANZ) and similar devices are provided 
below.
Literature Review Related to S.M.A.R.T. RADIANZ and Similar Devices
S.M.A.R.T. RADIANZ is a new device which has not been studied in any prior clinical investigations, 
however, the stent component of S.M.A.R.T. RADIANZ, the S.M.A.R.T. stent, is the same as that in 
previous generations of the S.M.A.R.T. device family.  The only difference is the stent delivery system in 
that S.M.A.R.T. RADIANZ delivers the stent via transradial arterial access to the target lesion(s). The 
S.M.A.R.T. device family has been evaluated for performance in lower extremity arterial disease indications 
(SFA, PPA and iliac arteries) in numerous studies.  
A recent literature search on the S.M.A.R.T. stent revealed that 10 publications reported outcomes in the 
SFA/PPA indication while four (4) publications reported outcomes in the iliac indication. To analyze the 
safety and performance of the S.M.A.R.T. device family in relation to similar self-expanding stents, an 
additional evaluation of the available literature data relative to the current state of the art (i.e., on 
similar/competitor/benchmark devices) was also performed based on 50 publications reporting outcomes 
in the SFA/PPA indication and eight (8) publications reporting outcomes in the iliac indication.
SFA/PPA Indication
The 10 publications5-14 reporting outcomes on use of the S.M.A.R.T. stent in the SFA/PPA indication 
included 1,617 subjects, 33.4% of whom were female, and whose mean lesion length was 105.4 mm (77.3-
157). The 50 publications15-64 reporting outcomes on use of similar devices in the SFA/PPA indication 
included 7,599 subjects, 32.8% of whom were female, and whose mean lesion length was 117.88 mm (10-
251).  
Both groups (S.M.A.R.T. and similar devices) had comparable rates of technical success, generally defined 
as successful completion of the procedure with less than or equal to 30% residual stenosis, of 99.5% and 
98.8%, respectively. The 30-day death rate [all-cause mortality (ACM)] was low for both groups with 0.0% 
and 1.0% rate for S.M.A.R.T. stent devices (one study reporting) and similar devices, respectively. At the 
one-year mark, ACM increased in both groups with 3.9% (n = 505) and 4.6% (n = 4,042) rate for S.M.A.R.T.
stent devices and similar devices, respectively.
The S.M.A.R.T. stent group saw a higher 1-year primary patency rate of 82.4% (6 studies) compared to the 
80.0% patency rate (33 studies) for the similar devices group. Neither group had a noteworthy number of 
cases of target lesion revascularization at 30 days (S.M.A.R.T.: 0.0%, similar devices: 0.6%), though rates 
increased at 1-year follow-up (S.M.A.R.T.: 10.3%, similar devices: 19.9%). Out of 3,568 patients in the 
similar device group, only 1.5% required major limb amputation after 1 year while 0.6% of the 276 patients
treated with S.M.A.R.T. required major limb amputation.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 20 of 83 
FINAL  
 
Iliac Indication
The four (4) publications65-68 reporting outcomes on use of the S.M.A.R.T. stent in the iliac indication 
included 2,328 subjects, 19.7% of whom were female, and whose mean lesion length was 56.8 mm (24.7-
60.0). The eight (8) publications69-76 reporting outcomes on use of similar devices in the iliac indication 
included 876 subjects, 27.9% of whom were female, and whose mean lesion length was 36 mm (25-57).  
Patients treated with the S.M.A.R.T. stent devices exhibited a technical success rate of 97.0% (n = 193) 
while the similar device group exhibited a similar rate at 97.6% (n = 560). The 30-day ACM rate was 2.0% 
and 1.4% for S.M.A.R.T. stents and similar devices, respectively.  The patency rate at 1-year for S.M.A.R.T. 
stents and similar devices was 92.0% and 92.9%, respectively. The slightly lower weighted averages are 
explained by the small cohort sizes for S.M.A.R.T. stents; however, the rates are similar and both results 
.
Literature Review Related to SABERX RADIANZ and Similar Devices
The new, 9 and 10 mm diameters are a line extension of the existing SABERX RADIANZ device available 
in 2-8 mm diameters and have not been studied in any prior clinical investigations.  The SABERX RADIANZ 
device 
Dilatation Catheter (SABERX).   
There is currently no literature available which report outcomes of using the SABREX RADIANZ, SABERX 
or any other Cordis PTA dilatation catheter in procedures involving a radial-to-peripheral treatment 
approach.  A literature search performed on other PTA catheters used in a radial-to-peripheral approach 
revealed the following:
In the prospective, observational, REACH PVI (Radial accEss for nAvigation to your cHosen lesion for 
Peripheral Vascular Intervention) study, 49 out of 50 patients were deemed procedurally successful.
Therefore, the conclusion was that transradial orbital atherectomy by percutaneous transluminal 
angioplasty (PTA) for lower extremity PAD is feasible and demonstrates a favorably safety profile, however, 
as the study points out, more studies and devices are needed so the transradial arterial access approach 
can be taken for any endovascular procedure.3
2
Products
Cordis US Corp. is the legal manufacturer of all investigational and CE marked product used in this study.  
2.1
Investigational Products
S.M.A.R.T. RADIANZ
The S.M.A.R.T. RADIANZ device is designed to deliver the S.M.A.R.T.
self-expanding stent (S.M.A.R.T.
stent) to the iliac arteries, superficial femoral arteries and/or proximal popliteal arteries using a 6F (2.0 mm) 
sheathed delivery system introduced through the radial artery. The S.M.A.R.T. stent is composed of a nickel 
titanium alloy (nitinol). A total of 12 (6 at each end) tantalum radiopaque markers are located on the ends 
of the stent. The stent is a flexible, fine mesh tubular prosthesis that expands upon deployment to appose
the vessel wall. Upon deployment, the stent imparts an outward radial force on the luminal surface of the 
vessel to establish patency. The S.M.A.R.T. stent is already CE marked for treating lesions in the iliac, 
superficial femoral and proximal popliteal arteries whereas the S.M.A.R.T. RADIANZ device is a 
new/investigational product.
The S.M.A.R.T. RADIANZ device is available in stent diameters ranging from 6 to 10 mm. Stent lengths 
range from 20 to 150 mm for 6, 7 and 8 mm stent diameters and from 20 to 80 mm for 9 and 10 mm stent 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 21 of 83 
FINAL  
 
diameters.  Stents with 6 and 7 mm diameters are available only in a delivery system with a 190 cm length;
stents with an 8 mm diameter are available in a 190 cm or 150 cm long delivery system; stents with a 9 or 
10 mm diameter are available only in a 150 cm long delivery system. The complete matrix showing all 
sizes in which the S.M.A.R.T. RADIANZ device is supplied is presented as Table 3.
Table 3: S.M.A.R.T. RADIANZ Size Matrix
Delivery 
System
Length
(cm)
Stent
Diameter
(mm)
Stent Length (mm)
20
30
40
60
80
100
120
150
190
6
X
X
X
X
X
X
X
X
190
7
X
X
X
X
X
X
X
X
190
8
X
X
X
X
X
X
X
X
150
X
X
X
X
X
X
X
X
150
9
X
X
X
X
X
150
10
X
X
X
X
X
All sizes of the S.M.A.R.T. RADIANZ device will be
The Instructions for Use (IFU) and the 
for the S.M.A.R.T. RADIANZ device will 
be provided by the sponsor and should be referred to for a more detailed description of the device and 
information on its intended purpose, indications/contraindications, warnings, precautions, potential 
complications, storage, handling, directions for use, necessary training and experience for use, etc. prior to 
the enrollment of and use of the device on any subjects in this study.
SABERX RADIANZ: 9 and 10 mm Diameters
The SABERX RADIANZ device is a catheter with a distal inflatable balloon. The catheter utilizes a rapid 
exchange design, consisting of a single inflation lumen and a distal guidewire lumen. The guidewire lumen 
begins at the distal tip and terminates at the guidewire exit port. The proximal hub is used as a balloon 
inflation port. Radiopaque marker bands indicate the dilating section of the balloon and aid in balloon 
placement. For balloon lengths greater than or equal to 10 cm, the distal section will have one (1) marker 
band and proximal section will consist of two (2) adjacent marker bands. For balloon lengths less than 10 
cm, the distal and proximal section will have each one (1) marker band. The catheter tip is tapered to ease 
entry into peripheral arteries and to facilitate the crossing of tight stenoses. SABERX RADIANZ balloons 
are coated with a hydrophilic material designed to increase lubricity throughout the lifetime of the device.
Currently, the SABERX RADIANZ device is CE marked for diameters of 2, 2.5, 3, 3.5, 4, 5, 6, 7, and 8 mm
(see Section 2.2.2 below). The 9 and 10 mm diameters for this device are new/investigational, for which 
available balloon lengths range from 2 through 10 cm, as presented in Table 4.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 22 of 83 
FINAL  
 
Table 4:  SABERX RADIANZ 9 and 10 mm Diameter Size Matrix
Balloon 
Length
(cm)
Balloon 
Diameter (mm)
9
10
2
X
X
3
X
X
4
X
X
6
X
X
8
X
X
10
X
X
All SABERX RADIANZ units with 9 and 10 mm diameters will be
The IFU for the 9 and 10 mm diameters of the SABERX RADIANZ device and the IB for the SABERX
RADIANZ device will be provided by the sponsor and should be referred to for a more detailed description 
of the device and information on its intended purpose, indications/contraindications, warnings, precautions, 
potential complications, storage, handling, directions for use, necessary training and experience for use, 
etc. prior to the enrollment of and use of the device on any subjects in this study.
2.2
CE Marked Products
BRITE TIP RADIANZ
The CE marked, BRITE TIP RADIANZ device is a catheter guiding sheath that facilitates percutaneous 
entry of an intravascular device into the peripheral vasculature through the radial artery. The sheath surface 
has a hydrophilic coating to enhance entry and withdrawal during vessel access.
A hemostasis valve 
facilitates entry and withdrawal of intravascular devices through the catheter guiding sheath and minimizes 
the back-flow of blood.
It has a hydrophilic coating and a multi-segmented braided design for optimal 
pushability, kink resistance and back-up support. The BRITE TIP RADIANZ device is available in working 
lengths of 110 cm and 135 cm. 
The IFU for the BRITE TIP RADIANZ device will be provided by the sponsor and should be referred to for 
a 
more 
detailed 
description 
of 
the 
device 
and 
information 
on 
its 
intended 
purpose, 
indications/contraindications, warnings, precautions, potential complications, storage, handling, directions 
for use, etc. prior to the enrollment of and use of the device on any subjects in this study.
SABERX RADIANZ: 2 through 8 mm Diameters
The SABERX RADIANZ device is CE marked for all diameters from 2 through 8 mm.  Balloons that are 2
through 6 mm in diameter are available in lengths from 2 through 30 cm; balloons that are 7 or 8 mm in 
diameter are available in lengths from 2 through 10 cm as shown in Table 5.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 23 of 83 
FINAL  
 
Table 5: SABERX RADIANZ 2 through 8 mm Diameter Size Matrix
Balloon 
Length
(cm)
Balloon Diameter (mm)
2
2.5
3
3.5
4
5
6
7
8
2
X
X
X
X
X
X
X
X
X
3
X
X
X
X
X
X
X
X
X
4
X
X
X
X
X
X
X
X
X
6
X
X
X
X
X
X
X
X
X
8
X
X
X
X
X
X
X
X
X
10
X
X
X
X
X
X
X
X
X
15
X
X
X
X
X
X
X
20
X
X
X
X
X
X
X
25
X
X
X
X
X
X
X
30
X
X
X
X
X
X
X
Of all the CE marked sizes for the SABERX RADIANZ device, only those in diameters from 4 through 
8 mm will be available in this study. 
The IFU for the 2 through 8 mm diameters of the SABERX RADIANZ device and the IB for the SABERX 
RADIANZ device will be provided by the sponsor and should be referred to for a more detailed description 
of the device and information on its intended purpose, indications/contraindications, warnings, precautions, 
potential complications, storage, handling, directions for use, etc. prior to the enrollment of and use of the 
device on any subjects in this study.
3
Study Objectives
The primary objective of this clinical investigation is to evaluate acute safety and efficacy of the S.M.A.R.T. 
TM Guiding Sheath and 
SABERX RADIANZTM PTA Balloon Catheter, to deploy the S.M.A.R.T.TM Nitinol Stent, in the treatment of 
patients with obstructive iliac or femoropopliteal arterial disease via radial artery access.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 24 of 83 
FINAL  
 
4
Indications
4.1
Investigational Products
S.M.A.R.T. RADIANZ
The S.M.A.R.T. RADIANZ device is indicated for use to improve luminal diameter for the treatment of 
patients with de novo or restenotic, native lesion(s) of the superficial femoral artery and/or proximal popliteal 
artery with total lesion length up to 150 mm and a reference vessel diameter ranging from 4 mm to 7 mm,
or of the Iliac artery with total lesion length up to 100 mm and a reference vessel diameter ranging from 4 
mm to 9 mm.
SABERX RADIANZ: 9 and 10 mm Diameters
The SABERX RADIANZ device in the 9 and 10 mm diameters is indicated to dilate stenoses in the iliac,
femoral, and proximal popliteal arteries. The device is also indicated for post-dilatation of balloon-
expandable and self-expanding stents in the peripheral vasculature.
4.2
CE Marked Products
BRITE TIP RADIANZ 
The BRITE TIP RADIANZ device is indicated for intravascular introduction of interventional and/or 
diagnostic devices into the peripheral vasculature through the radial artery. In this study, this device will be 
used within its approved indications.
SABERX RADIANZ: 2 through 8 mm Diameters
The SABERX RADIANZ device in the 2 through 8 mm diameters is indicated to dilate stenoses in the iliac, 
femoral, ilio-femoral, popliteal, infra popliteal and renal arteries.
The device is also indicated for post-
dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature. As this device will 
be used for stenoses in the iliac and/or femoropopliteal arteries in this study, it will be used within its 
approved indications.
5
Benefits/Risks
5.1
S.M.A.R.T. RADIANZ
5.1.1
Benefits
The potential benefits of using S.M.A.R.T. RADIANZ via radial artery access include:
Reduced access site and major complications
Lower bleeding risk
Faster mobilization
Cost-effectiveness
The potential benefit of the S.M.A.R.T. stent within the S.M.A.R.T. RADIANZ device includes improved 
arterial luminal diameter in patients with peripheral artery disease.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 25 of 83 
FINAL  
 
5.1.2
Risks
The following are possible risks, categorized by occurrence (Improbable, Remote, Occasional, Probable, 
Frequent), associated with use of S.M.A.R.T. RADIANZ and S.M.A.R.T. stent.
Occurrence Rate: Improbable, <0.002%
Abrupt closure
Access failure
Access site complications
Allergic/anaphylactoid 
reaction to anticoagulant 
and/or antithrombotic 
therapy or contrast 
medium
Allergic reaction to nitinol
Allergic reaction
Amputation
Anemia/blood loss
Arrhythmia
Blue toe syndrome
Bradycardia
Worsened claudication or 
rest pain
Death 
Encephalopathy (new or 
worse) (altered mental 
state or confusion)
Fever
Fistulization
Gangrene
Gastrointestinal bleed from 
anticoagulation/antiplatelet 
medication
Hematoma
Hemorrhage
Hypotension/hypertension
Iliac artery spasm
Infection
Infection and/or sepsis
Intimal tear/dissection
Ischemia
Multi-organ failure
o
Muscle 
hemorrhage
Pain
Pneumothorax
Pseudoaneurysm
Renal failure
Respiratory arrest
Sepsis
Stent embolization
Stent migration
Stent occlusion
Stroke
Transient Ischemic 
Attack (TIA)
Trauma to adjacent 
structures
Worsened claudication or 
rest pain
Occurrence Rate: Remote, 0.002%-<0.02% 
Aneurysm
Angina/coronary ischemia/myocardial infarction
Arterial restenosis
Arterial stenosis or dissection
Arteriosclerosis
Arteriovenous fistula
Disseminated intravascular coagulation
Edema, peripheral
Embolism
Emergent repeat hospital intervention or surgery
Necrosis
Restenosis of the stented segment
Tissue necrosis
Vascular injury, including perforation, rupture and dissection
Vasospasm
Vessel occlusion/thrombosis, puncture site (restenosis or recurrent stricture)
Occurrence Rate: Occasional, 0.02% to <1%
No risks

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 26 of 83 
FINAL  
 
Occurrence Rate: Probable, 1% to <10%
No risks
Occurrence Rate: Frequent, >10%
No risks
5.2
BRITE TIP RADIANZ
NOTE:  As BRITE TIP RADIANZ is a CE marked device to be used within its intended purpose, the 
same benefits and risks apply as they do for the use for which the device has been approved. 
5.2.1
Benefits
The BRITE TIP RADIANZ device allows for radial artery access to successfully complete diagnostic and 
treatment procedures.  The potential benefits of using BRITE TIP RADIANZ are similar to other access 
sheaths that have been intended and optimized for use via a transradial approach.  In general, when 
vascular access is obtained by needle puncture, avoiding a surgical incision, the need for analgesia and 
sedation is reduced. Percutaneous access often results in shorter recovery times and thereby, length of 
hospital stay.77 Compared to traditional femoral access, the transradial approach is associated with a lower 
bleeding rate, faster time to ambulation and shorter hospital stay.78 Also, these benefits allow a wider range 
of patients to be treated, including those who otherwise would be contraindicated from undergoing surgery 
due to operative risk and comorbidities. 
5.2.2
Risks
The following are possible risks, categorized by occurrence (Improbable, Remote, Occasional, Probable, 
Frequent), associated with use of BRITE TIP RADIANZ.
Occurrence Rate: Improbable, <0.002%
Air Embolism
Allergic reaction (contrast medium and 
medications)
Hematoma at puncture
Hemorrhage
Inflammation / Infection / Sepsis
Perforation of vessel wall
Peripheral nerve injury
Thrombus formation
Occurrence Rate: Remote, 0.002% to <0.02%
Abrupt vessel closure                                                         
Additional intervention
Embolic Stroke/Cerebral Infarct
Intimal tear
Necrosis
Pain
Vascular complications (e.g., intimal tear, dissection, pseudoaneurysm, perforation, rupture, 
spasm, occlusion)
Occurrence Rate: Occasional, 0.02% to <1%
No risks

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 27 of 83 
FINAL  
 
Occurrence Rate: Probable, 1% to <10%
No risks
Occurrence Rate: Frequent, >10%
No risks
5.3
SABERX RADIANZ
NOTE: The benefits and risks associated with using the SABERX RADIANZ device with the 
investigational, 9 and 10 mm diameters are the same as those which apply for the uses for which 
the device with the CE marked, 2 through 8 mm diameters have been approved.      
5.3.1
Benefits
The potential benefits of using SABERX RADIANZ in patients with arterial stenosis are that it allows for 
improved arterial luminal diameter (opens the arterial lumen), prepares the lesion for stenting and/or 
ensures the stent has been fully expanded and apposing the arterial wall.
5.3.2
Risks
The following are possible risks, categorized by occurrence (Improbable, Remote, Occasional, Probable, 
Frequent), associated with use of SABERX RADIANZ.
Occurrence Rate: Improbable, <0.002%
Acute Myocardial Infarction
Allergic reaction (contrast medium and medications)
Amputation
Arrhythmias
Arteriovenous fistula
Bradycardia
Death
Hypotension/hypertension
Inflammation/infection/sepsis
Neurological events, including peripheral nerve injury, transient ischemic attack, and/or stroke 
Organ failure (single, multiple)
Procedural complications: bleeding, hypotension, access site complications
Pseudoaneurysm
Renal failure
Vascular complications (e.g., intimal tear, dissection, pseudoaneurysm, perforations, rupture, 
spasm, occlusion)
Occurrence Rate: Remote, 0.002% to <0.02%
Abrupt vessel closure
Access site complication

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 28 of 83 
FINAL  
 
Dissection
Embolism
Hematoma at puncture site
Hemorrhage
Ischemia
Necrosis
Pain
Restenosis of the dilated vessel
Thrombosis
 
Occurrence Rate: Occasional 0.02% to <1%  
Potential for balloon burst and potential complications (rated burst pressure)
Occurrence Rate: Probable, 1% to <10%
No risks
Occurrence Rate: Frequent, >10%
No risks
5.4
Benefit and Risk Assessment
A comprehensive analysis of the individual risks, the overall residual risk, and the anticipated medical 
benefits as well as risk management for the Cordis SMART Stent Family and for the family of Cordis PTA
catheters are detailed in the documents,
Report for SMART RADIANZ Self-Expanding 
(100235021/Rev.8), respectively.
5.4.1
Benefits
Transradial access (TRA) is a safe and feasible alternative to transfemoral access for a range of peripheral 
interventions, achieving success in 93.2% of cases.79
Most of the disadvantages of the femoral artery access approach are non-existent when accessing the 
radial approach. Even in obese patients, the radial artery is close to the skin surface, making the initial 
needle puncture simple and straightforward. In addition, any bleeding can be readily seen and addressed 
immediately - a short compression of the radial artery can stop bleeding even when the patient has been 
aggressively anticoagulated.
Lastly, the radial artery is not close to a major nerve (as opposed to the 
80
Overwhelming evidence demonstrating these advantages as well as reduced access-related complications, 
early ambulation and discharge, cost savings, and patient preference because of improved post-procedure 
comfort with faster recovery are some of the important reasons for the increased adoption of transradial 
approach 
for 
coronary, 
peripheral, 
and 
cerebrovascular 
endovascular 
procedures
worldwide.81,82,83,84,85,86,87,88,89,90 Led by the interventional cardiology community, large randomized 
multicenter trials such as the Radial versus Femoral Access for Coronary Angiography and Intervention in 
Patients with Acute Coronary Syndrome (RIVAL) and Minimizing Adverse Haemorrhagic Events by 
Transradial Access Site and the Systemic Implementation of AngioX (MATRIX) studies, with over 7,000 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 29 of 83 
FINAL  
 
patients each, have reported a greater than 60% reduction in vascular complications as well as significant 
decreases in all-cause mortality and net adverse clinical events with TRA.90,91  From the PREVAS study, 
immediate ambulation as opposed to bed rest after femoral procedures, reduced post-procedure nursing 
care, reduced hospital stay, and therefore cost, with an overwhelming patient preference for transradial 
angiography have all been reported.92
 
5.4.2
Risks
The TRA approach, however, does come with access challenges. Failure to access the radial artery is 
typically due to puncture error or radial artery spasm (RAS). These two reasons for failure are intimately 
linked as failed attempts at piercing the radial artery quickly result in RAS, which in turn results in even 
greater difficulty in accurately puncturing and cannulating the small artery in spasm.93  
Imaging modalities have shown to improve and/overcome this technical barrier. The routine use of 
ultrasound for radial artery puncture nearly eliminates access failure and improves efficiency. In a 
randomized, multicenter trial of 692 patients, ultrasound guidance resulted in a significantly reduced number 
of attempts (mean 1.65±1.2 vs 3.05±3.4, p<0.0001) and time to access (88±78s vs 108±112s, p=0.006), 
as well as improved first-pass success (64.8% vs 43.9%, p<0.0001)93 This reduction in attempts is important 
in decreasing the likelihood of RAS as well as preventing patient pain, swelling, and hematomas at the 
access site. Of note, when radial artery access failure occurs distally, attempts to cannulate the radial artery
more proximally can be done prior to conversion to TFA. The entire length of the radial artery distal to the 
brachioradialis muscle (in which the artery dives below the fascia) is easily accessed and associated with 
minimal risk.
Additionally, it is expected that enrolled subjects will be exposed to some amounts of radiation from the 
angiogram imaging required in this study. The total radiation dose to which subjects (of average size) will 
be exposed from their participation in this study ranges from approximately 0.05 mSv to 5 mSv (depending 
on the artery undergoing treatment) and may or may not be comparable to what they would be otherwise 
exposed to if they did not take part in this study, based on standard of care at the study institution.
Nevertheless, the total radiation exposure from angiography would be a multiple of natural radiation 
exposure for an individual who does not undergo this type of procedure.
5.4.3
Summary of Assessment 
As mentioned above, a comprehensive review and analysis of the benefits and risks involving the
investigational study devices are provided within the respective risk management reports.
Additionally, the risk/benefit analyses summarized above, the Clinical Evaluation Reports and post-market 
surveillance data (obtained from active customer feedback, complaints, quality and production information 
and periodic literature reviews), which provide objective evidence to support the risk/benefit profile,
conclude that the potential benefits associated with the medical procedures in which the SMART RADIANZ 
Self-Expanding Stent (SES) Family and Cordis PTA catheters are used outweigh the potential risks. 
From a clinical perspective, the devices achieve their intended performance during normal conditions of 
use as stated in the labeling materials. Known and foreseeable risks and adverse events are minimized 
and acceptable when weighed against the benefits of the intended performance. At this time, no unknown 
device or procedural interaction is suspected, and the device is generally used as indicated by the label.
Based on the analysed information, the SMART RADIANZ SES Family of devices and Cordis PTA catheters 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 30 of 83 
FINAL  
 
have been demonstrated as safe and effective devices when used in accordance with their Instructions for 
Use.
Analysis of published literature and post-market surveillance data have identified no new/previously 
unknown hazards (safety or performance issues) and/or increased frequency/severity of known hazards 
during use of these products. The safety profile and types/incidences of complications reported in the 
published literature were consistent with hazards identified by risk assessment for these devices and with 
reported complaints. Review of the complaints database, which includes the rate of occurrence for all 
categories of complaints, also showed that these and other, commercially-available devices, which have 
been on the market for over twenty years, have similar potential risks and a known and stable history of 
adverse events, with most events being an inherent risk of the percutaneous vascular procedure.
Based on the results and completeness of the risk management process as listed above as well as the 
criteria defined in the Risk Management Plan, it is concluded that the SMART Stent Family of devices and 
Cordis PTA catheters remain safe and effective treatment options for treating stenotic lesions. Considering 
the risk profile and evidence of the same when compared to the benefits, it is believed that the potential 
risks are outweighed by the potential benefit to the patients.  
6
Study Design
This is a multi-center, single-arm, non-randomized, prospective, pivotal (pre-market) clinical study enrolling 
approximately 159 subjects with obstructive iliac or femoropopliteal arterial disease.
-
cohort: A subgroup of approximately 30 subjects, consisting of the first two (2) enrolled 
subjects at each study site (as applicable)
-
.  Such 
subjects will be pre-
-
and must meet all criteria 
for enrollment, however, they will be followed up and evaluated to 30 days post-procedure only for 
safety and not included in any endpoint analyses.
-
intended to allow less experienced investigators to overcome the learning 
curve
in performing the study procedure and for all investigators to become better 
accustomed/acclimated to the operation/use of all study devices through the first couple study 
subjects treated at their respective sites, but without including such subjects in endpoint analyses.
All enrolled subjects 
-
will be followed up to 30 days post-
procedure.  
To adequately assess the efficacy and safety of both iliac and femoropopliteal artery treatment 
under study, a minimum of 30 subjects will be required for each of the two indications 
(femoropopliteal and iliac).
A goal of this study is to collect data on 30 uses of the SABERX device.  Ideally those uses will be 
evenly distributed across the iliac and femoropopliteal arteries. 
There will be approximately 15 participating study sites across Europe.
The RADIANCY study started (first subject enrollment) in Q2 2022 and is anticipated for completion (last 
subject last visit) in Q4 2023.
The sponsor, Cordis US Corp. (Cordis), will finance the study and arrange for all liability insurance needs.
All devices (both investigational and CE marked) will be provided free of charge to all participating sites by 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 31 of 83 
FINAL  
 
the sponsor as none are yet commercially available.   The costs for all non-standard-of-care tests required 
by this study protocol will be covered by the sponsor.
Each study site will be contracted with Cordis via a Clinical Trial Agreement to execute all study activities 
as described in this protocol.
7
Inclusion and Exclusion Criteria
Prior to any study-specific activities, all subjects must sign and date the most current, EC approved 
Informed Consent Form (ICF).
7.1
Inclusion Criteria
Subjects must meet ALL of the following inclusion criteria to be enrolled in the study:  
1.
Age 
18 years
2.
For women of child-bearing potential, a negative pregnancy test within seven (7) days prior to the 
index procedure
3.
Symptomatic leg ischemia or ischemic ulcerations that do NOT exceed digits of the foot 
(Rutherford/Becker Classification category 2, 3, 4 or 5)
4.
, as assessed by duplex ultrasound
5.
Eligibility for standard surgical repair, if necessary
6.
A patient who requires a coronary intervention should have it performed at least seven (7) days prior
to treatment of the target lesion
7.
The patient must provide documented informed consent and any other documented authorization, as 
required, prior to initiation of the study procedure
8.
Per Investigator assessment, the patient is willing and able to be followed up to 30 days post-
procedure for evaluation and complete all required assessments per the study protocol.
Inclusion criteria 9 and 10 AND 11a through 14a OR 11b through 16b (whichever is applicable) 
would be assessed via baseline angiography performed at the time of index procedure:
9.
The Investigator has assessed that the patient is a suitable candidate (i.e, meets all inclusion criteria 
and none of the exclusion criteria), for treatment of a lesion in the iliac, superficial femoral and/or 
proximal popliteal arteries via transradial approach and is eligible for conversion from a transradial to 
transfemoral approach, if it becomes necessary.
10. The guidewire is across the target lesion(s) and located intraluminally within the distal vessel following 
a transradial approach
Patients whose target lesion is in the iliac artery must meet these additional criteria prior to 
enrollment:
11a. A single de novo
12a. Stenotic lesion (one long or multiple serial/tandem lesions) 
100 mm, by visual assessment, within 
or across the common or external iliac arteries.  The stenosis must be treatable with no more than 
two stents (while minimizing stent overlap)  
13a. Reference vessel diameter (RVD) ranging from 4.0 to 9.0 mm by visual assessment

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 32 of 83 
FINAL  
 
14a. Angiographic evidence of a patent profunda or superficial femoral artery in the diseased (target) limb
Patients whose target lesion is in the SFA and/or PPA must meet these additional criteria prior to 
enrollment:
11b.  A single de novo or restenotic lesion 
50% stenosis in the SFA and/or PPA
12b.  Stenotic lesion (one long or multiple serial/tandem lesions) 
150 mm, by visual assessment, within 
or across the SFA and/or PPA.  The stenosis must be treatable with no more than two stents (while 
minimizing stent overlap) 
13b. RVD ranging from 4.0 to 7.0 mm by visual assessment
14b. All lesions are to be located at least three centimeters proximal to the superior edge of the patella
15b. Patent infrapopliteal artery, i.e., single vessel runoff or better with patency (<50% stenosis) of at least 
one of three vessels to the ankle or foot
16b. Adequate
to treatment of the target lesion
(defined as < 30% stenosis after PTA or stenting) prior to treatment of the target lesion
7.2
Exclusion Criteria 
Subjects will be excluded if they meet ANY of the following exclusion criteria:
1.
The patient has had/experienced any prior intervention/treatment to the target vessel within 90 days 
prior to enrollment (e.g., previously implanted graft in the aorta or target vessel; stroke; cryoplasty,
laser or atherectomy; abdominal aortic aneurysm or aneurysm of the iliac, superficial femoral or 
popliteal artery). 
2.
Previously deployed stent at the site of the target lesion.
3.
The patient has post-surgical stenosis and anastomotic suture treatments of the target vessel.
4.
Requires general anesthesia for percutaneous transluminal angioplasty (PTA) and/or the stenting 
procedure.
5.
Use of mechanical devices on or thrombolysis of the target vessel within 72 hours prior to the index 
procedure without complete resolution of the thrombus.
6.
The patient is receiving any form of dialysis.
7.
The patient is receiving any form of immunosuppressant therapy.
8.
Planned amputation.
9.
Established vasospastic disease.
10.
Glomerular filtration rate (GFR) < 30 mL/min within 7 days prior to the index procedure.
11.
The patient has a history of neutropenia, coagulopathy, and/or thrombocytopenia.
12.
Thrombophlebitis, uremia, or deep venous thrombus, within past 30 days prior to the index 
procedure
13.
Bleeding diathesis.
14.
Known allergies or intolerance to antiplatelet, anticoagulant or thrombolytic medications including 
but not limited to aspirin, clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®) or heparin that cannot 
be medically managed.
15.
Known allergy or intolerance to Nitinol (nickel titanium).

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 33 of 83 
FINAL  
 
16.
Known allergy to contrast agent that cannot be medically managed before treatment with steroids 
and/or antihistamines.
17.
Known or suspected active infection at the time of the index procedure.
18.
Patient is currently participating in another investigational drug or medical device study that has not 
completed primary endpoint(s) evaluation or clinically interferes with the endpoints from this study or 
is planning to participate in such a study prior to their completion of this study.
19.
Patient has had a major surgical or interventional procedure unrelated to this study within 30 days 
prior to enrollment or is anticipated/planned to have such a procedure within 30 days after enrollment. 
Exclusion criteria 20 through 25 would be assessed via baseline angiography performed at the 
time of index procedure:
20.
Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity 
which would prevent delivery of the stent device.
21.
Noted perforation of the target vessel.
22.
Stent placement required across or within 0.5 cm of the SFA/profunda femoris artery (PFA) 
bifurcation.
23.
Cases of chronic total occlusion/in-stent restenosis/severe calcification in which there is pre-
determined inability to treat the target lesion with a single stent, or procedures pre-determined to 
require stent-in-stent placement to obtain patency.
24.
Presence of thrombus prior to crossing the lesion.
25.
treatment).
This study is designed to exclude children, pregnant women, and immunocompromised subjects, due to 
the nature of the procedure, device and indications.
8
Study Endpoints
8.1
Primary Endpoints
8.1.1
Primary Safety Endpoint
The primary safety endpoint is the occurrence rate of CEC-adjudicated, major radial access site 
complications attributed to study device or procedure through time of hospital discharge.
8.1.2
Primary Efficacy Endpoint
Technical success at the conclusion of the index procedure, defined as successful insertion of the 
successful deployment of the study device (S.M.A.R.T.TM stent) at the intended location, and successful 
withdrawal of the delivery system without conversion from radial to femoral artery access.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 34 of 83 
FINAL  
 
8.2
Secondary Endpoints
8.2.1
Secondary Safety Endpoints
Secondary safety endpoints include the following:
Peri-procedural (within 30 days post-index procedure):
o
Rate of device deficiencies for each of the three (3) devices
o
Rate of adverse events
o
Rates of death, index limb amputation and target lesion revascularization
o
Rate of procedural complications
Secondary Efficacy Endpoints
Technical success associated with use of the BRITE TIP RADIANZTM Guiding Sheath, defined as 
successful insertion of the device into the peripheral vasculature through the radial artery (allowing for 
introduction of interventional and/or diagnostic devices) and successful withdrawal of the device.
Procedural success associated with use of the SABERX RADIANZTM PTA Balloon Catheter for pre-
dilation and/or post-deployment stent dilatation (whenever applicable), defined as successful insertion 
of the device into the peripheral vasculature through the radial artery, successful inflation and deflation 
of the balloon, successful withdrawal of the device, and achievement of a final residual diameter 
stenosis of < 30% at the conclusion of the index procedure.
8.3
Additional Data Points 
Data will be collected to evaluate the following health economics outcomes: 
Fluoroscopy time and procedural time, defined as the time of sheath introduction to time of vascular 
closure.
Time to achieve hemostasis,
defined as the time elapsed from removal of the BRITE TIP RADIANZTM Guiding Sheath to the time 
that hemostasis was first observed.Time to ambulation, defined as when the subject can stand up and 
walk any distance 
Time to hospital discharge
Time to hospital discharge eligibility (when physician examines and if all is well, gives 
discharge orders). 
Method to achieve closure of the transradial artery access site
Quality of Life Assessments: Data will be also collected to evaluate health-related, quality-of-life in all 
subjects by administeringthe 36-item Short Form Health Survey (SF-36) and the EuroQOL-5 Dimension 
(EQ-5D) standardized, validated questionnaires to assess general and disease-specific outcomes. Brief 
descriptions of these two questionnaires are as follows
The SF-36 is a patient-reported survey of general health and well-being.
It consists of 36 items 
grouped in these dimensions: physical functioning, physical and emotional limitations, social 
functioning, bodily pain, general and mental health. Higher scores indicate better health status.
The EQ-5D questionnaire is used for the assessment of health state utility and visual analog rating,
which is a quantitative measure of overall health status.  It consists of five (5) dimensions: mobility, 
self-care, usual activities, pain/discomfort and anxiety/depression.  
8.4
Rationale for Study Endpoints
Each of the primary and secondary safety and/or efficacy endpoints above aligns with the primary objective 
of the study in evaluating 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 35 of 83 
FINAL  
 
when used with the BRITE TIP RADIANZTM Guiding Sheath and SABERX RADIANZTM PTA Balloon 
Catheter in treating femoropoliteal or iliac artery lesions via a radial artery approach.  
Regarding the S.M.A.R.T. RADIANZ device in particular: since the investigational S.M.A.R.T. RADIANZ
delivery system incorporates the CE marked S.M.A.R.T. stent, for which there is an abundance of short-
term and long-term clinical data available from its evaluation in previous, Cordis-sponsored studies, the 
main purpose of this study is to assess the safety and performance (outcomes) of the delivery system
versus the stent. There is proven, long-term primary patency through 10 years and low stent fracture rate 
through 3 years following implantation of the S.M.A.R.T. stent. Therefore, rates of vessel patency,
restenosis, stent fractures, etc. have not been included as pre-specified endpoints for this study.
The various health economic endpoints will be used to determine if there are cost savings/benefits, such 
as decreased procedural/treatment and hospitalization costs, for patients who are eligible for and undergo 
procedures that can be completed via a transradial versus transfemoral arterial approach. General and 
disease-specific outcomes assessed via the SF-36 and EQ-5D standarized, validated questionnaires will 
help determine if there is overall, improved quality-of-life in the short-term in patients that undergo stenting 
procedures via transradial approach to 30 days post-procedure.
9
Informed Consent
Prior to enrollment and performance of any study-specific activities or procedures, the study team shall:
1.
Provide each prospective subject with a full explanation of the study (including all potential benefits 
and risks) that is also documented (i.e., informed consent form) and ensure they have understood 
all information that has been presented to them.
a. The informed consent form (ICF) should enable the subject to understand:
i.
the nature, objectives, benefits, implications, risks and inconveniences of the clinical 
investigation;
ii.
the subject's rights and guarantees regarding his/her protection, in particular his/her right 
to refuse to participate in and the right to withdraw from the clinical investigation at any 
time without any resulting detriment and without having to provide any justification;
iii.
the conditions under which the clinical investigations are to be conducted, including the 
expected duration of the subject's participation in the clinical investigation; and
iv.
the possible treatment alternatives, including the follow-up measures if the participation of 
the subject in the clinical investigation is discontinued.
b. The ICF shall:
i.
Be comprehensive, concise, clear, relevant and understandable to the subject;
ii.
Be provided in a prior interview with a member of the clinical investigation team who is 
appropriately qualified under national law and delegated to this responsibility; gives 
special attention to the information needs of specific patient populations and individual 
subjects as well as to the methods used to provide the information; verifies the subject 
has understood the information;
iii.
Include information about an applicable damage compensation system; and 
iv.
Include the unique, study identification number and information about the availability of 
clinical study results to the subject, to the extent possible, via a clinical study report and 
summary presented in terms understandable to the intended user, irrespective of the 
outcome of the clinical study.
2.
Allow adequate time for the prospective subject to read the most current EC-approved informed 
consent form (ICF) and consider participation in the study and for addressing any/all of their 
questions.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 36 of 83 
FINAL  
 
3.
Obtain documented consent [handwritten or electronic (if applicable) signature and date on the 
ICF] from the prospective subject after it is certain they understand all implications of participating 
in the study. The ICF shall also be signed by the Investigator or person performing the interview.  
Alternatively, in situations where the subject is unable to write, consent may be provided in the 
presence of at least one impartial witness, who shall sign and date the ICF.
 
 
The reflection period (time between explaining the study/providing written information to the prospective 
subject and obtaining documented consent) can vary based on individual circumstances, but should be at 
least 24 hours in duration or per standard practice or institutional policies at each site.
A copy of the ICF (or other record by which informed consent had been provided) that is signed by the 
subject and the Investigator and/or designee obtaining consent will be provided to the subject.
The Investigator and/or designee must clearly document the process for obtaining informed consent, 
including the date and time of obtaining consent, in the subj
responsibility to ensure that the informed consent process is performed in accordance with ICH-GCP
applicable international standards and all applicable local and federal regulations.
Documented informed consent must be obtained within 60 days prior to the index procedure.
Exceptions to obtaining documented informed consent prior to the initiation of study-specific procedures 
would be in cases where necessary to eliminate an immediate apparent hazard and protect the life or 
physical well-being of a study subject, as determined by the investigator. See section 15.5.3 (Emergency 
Deviations). In such cases, informed consent must be obtained from the subject following the same process 
as described above as soon as possible following the index procedure.
10
Screening and Enrollment
10.1
Overall Process
The sequence of steps in the evaluation of potential patients for study enrollment is described as follows 
and diagrammed in Figure 1. Refer to Section 7 for a list of all inclusion and exclusion criteria.
1.
Pre-Screening:  The potential patient will be evaluated against all inclusion and exclusion 
criteria that can be assessed via review of their medical records.
2.
Informed Consent: A patient who is shown to qualify for the study based on medical record 
review alone will be asked to provide documented informed consent to participate in the study 
as described in Section 9.
3.
Screening: A patient who provides informed consent will be evaluated against all other 
inclusion and exclusion criteria via study-specific assessments performed through the time of 
index procedure (i.e., angiography).
4.
Enrollment: A patient who meets all criteria as outlined in Section 10.3 can be enrolled into the 
study.
Figure 1: Patient Evaluation Process

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 37 of 83 
FINAL  
 
 
 
10.2
Pre-Screening and Screening
10.2.1 Data Collection and Assessments
In addition to obtaining documented informed consent within 60 days prior to the index procedure, the
following must be (except as indicated below) performed or obtained. Subjects will be verified to meet all 
inclusion criteria and none of the exclusion criteria prior to device implantation.
1.
Demographic Data: Including but not limited to age, sex, weight, height, and race
2.
Medical/Surgical History: Including but not limited to vascular and non-vascular clinical history, 
risk factors, medical and surgical cardiovascular background (i.e., history of cardiac, kidney or 
peripheral vascular disease, diabetes, hypertension, bleeding history, hypercholesterolemia, 
TIA, stroke, renal insufficiency, allergies, tobacco use)
3.
Physical Examination: Complete review of systems must be completed within seven (7) days
prior to the day of the index procedure
4.
Concomitant Medications (recommended): Aspirin AND either Clopidogrel bisulfate (Plavix®)
or Ticlopidine (Ticlid®).  Please see section 11.5.
5.
Laboratory Evaluations: Non-fasting results are acceptable.  The patient should be adequately 
hydrated prior to obtaining laboratory tests.  The following tests must be completed within seven 
(7) days prior to the day of the index procedure.
a.
Glomerular filtration rate assessment
b.
Pregnancy test (if the patient is female and of child-bearing potential)
6.
Duplex Ultrasound: This must be completed of the radial artery that will be used as the access 
site within seven (7) days prior to the day of the index procedure.  Refer to the Core Lab 
reference manual for guidelines on performing and submitting this assessment.
7.
Health-Related Quality of Life: Assessed via the SF-36 and EQ-5D questionnaires that are 
completed by the subject or administered to the subject by a study team member at the site (if 
possible) within seven (7) days prior to the day of the index procedure.
8.
Baseline Angiography: Performed at the time of index procedure
The baseline angiography (assessment 8) will be done at the time of the index procedure.  T
according to all anatomically-related inclusion/exclusion criteria, however, all angiograms will also be sent 
to the core lab for further analysis.
10.2.2 Screen Failures & Pre-Screen Failures
Pre-screen Failures: Pre-screen failures are defined as patients who are confirmed to not qualify for study 
participation according to the eligibility criteria after review of their medical records (i.e., prior to providing 
informed consent).  Such subjects will neither be treated with the study devices nor followed per protocol.
Pre-
Screening
Informed 
Consent
Screening
Enrollment

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 38 of 83 
FINAL  
 
Screen Failures: Any consented patient who is confirmed to not qualify for study participation according to 
the eligibility criteria will be considered a screen failure and will neither be treated with the study devices
nor followed per protocol.  
Signed informed consent forms and all applicable documentation including source records indicating 
rationale for screen failure classification and Screening/Enrollment logs or equivalent forms/screens in the 
Electronic Data Capture (EDC) system will be reviewed during monitoring visits for all screen failure 
patients.
10.2.3 Duration
The screening of potential patients for this study is anticipated to occur over a 4-6 month period.
10.3
Enrollment
The subject will be considered enrolled into the study after ALL of the following criteria have been met:
ICF has been signed/dated by all parties
All pre-screening and screening assessments have been completed
Vascular access has been obtained in the radial artery (i.e., time of puncture)
Subject has been assessed by the site against all study eligibility criteria, including those 
determined by angiography
11
Treatment Plan
11.1
Index Procedure
The Instructions for Use (IFU) provides detailed information on the product, safety, storage, design, 
deliverability, and sizing specifications for all three (3) devices: S.M.A.R.T. RADIANZ, BRITE TIP RADIANZ 
and SABERX RADIANZ.  All information within the IFU for each device should be reviewed prior to initiation 
of the index procedure and implantation of the study stent.
NOTE: Left side radial artery access is recommended/preferred for all subjects.
NOTE: There is currently no data available to support use of the study devices via the distal radial artery
as the access site.
CAUTION: The height of each subject must be considered to ensure the S.M.A.R.T. RADIANZ delivery 
system is adequate in length to be tracked to the site of the target lesion.
1.
Initial Angioplasty using SABERX RADIANZ PTA Balloon Catheter (if appropriate)
a.
An angioplasty balloon catheter should be selected to correspond to the diameter of the 
superficial femoral artery proximal to the lesion. The side arm of the introducer should be 
connected to a pressure transducer to record the arterial pressure distal to the obstruction. An 
initial dilation of the lesion should be made with an appropriately sized balloon catheter.
Whenever there is doubt about the dispensability of the lesion, the smallest appropriate balloon 
catheter should be used for the initial dilatation. 
Note: Stent placement is not indicated if the primary angioplasty is not technically successful. A 
technically successful angioplasty is one in which the guidewire and dilation catheter are 
passed through the lesion and dilatation of the lesion produces a lumen adequate to 
accommodate introduction of the stent delivery system.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 39 of 83 
FINAL  
 
b.
Following dilatation of the lesion, an arteriographic image should be recorded in order to 
determine the adequacy of the primary procedure.
2.
Select S.M.A.R.T. Stent Size
a.
Measure the length of the target lesion to determine the length of stent(s) required, as per 
Table 3. Size the stent length(s) to extend slightly proximal and distal to the lesion.
b.
The appropriate stent length(s) should be selected to cover the entire length of the lesion.
c.
The appropriate unconstrained stent diameter should be selected based on the vessel lumen 
diameter as per 
Table 6.
Table 6: Stent Size Selection Guide
Vessel Lumen Diameter
Unconstrained Stent 
Diameter
4.0
5.0 mm
6 mm
5.0
6.0 mm
7 mm
6.0
7.0 mm
8 mm
7.0
8.0 mm
9 mm
8.0
9.0 mm
10 mm
Note: Refer to product labeling for stent length information
3.
Insertion of BRITE TIP RADIANZ Guiding Sheath or Guide Catheter and Guidewire
a.
Access the treatment site utilizing the appropriate accessory equipment compatible with the 6F 
(2.0 mm) delivery system.
b.
Place a 6F guiding sheath of an appropriate length (110cm for a 150cm long delivery system
and a 135cm for a 190cm long delivery system) with an internal diameter of at least 2.2 mm.
c.
guiding sheath or guide catheter.
4.
Dilation of Lesion with SABERX RADIANZ PTA Balloon Catheter (if appropriate)
a.
Pre-dilate the lesion using standard PTA balloon catheter techniques.
b.
Remove the PTA balloon catheter from the patient while maintaining lesion access with the 
guidewire.
5.
Stent Deployment
a.
proximal and distal to the target lesion.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 40 of 83 
FINAL  
 
b.
Initiate stent deployment by rotating the thumbwheel in a clockwise direction while holding the
handle in a fixed position.
c.
While using fluoroscopy, maintain position of the radiopaque stent markers relative to the target 
lesion site. Watch for the distal radiopaque markers to begin separating. Separation of the 
distal stent markers signals that the stent is deploying. Continue turning the tuning dial to cause 
further separation of the distal radiopaque markers until the distal end of the stent obtains full 
wall apposition.
d.
Deployment is complete when the proximal markers oppose the vessel wall and the outer 
sheath radiopaque marker is proximal to the support member stent stop.
6.
Post-deployment Stent Dilatation with SABERX RADIANZ PTA Balloon Catheter (if 
appropriate)
a.
While using fluoroscopy, withdraw the entire delivery system as one unit, over the guidewire, 
into the guiding sheath and out of the body. Remove the delivery device from the guidewire. Do 
not rotate the handle during withdrawal.
b.
Using fluoroscopy, visualize the stent to verify full deployment. Post-deployment balloon 
dilatation can be performed within the stent at any point along the lesion where there was 
incomplete expansion.
c.
Select an appropriate size PTA balloon catheter, dilate the lesion with conventional technique 
and remove the PTA balloon from the patient.
7.
Post Stent Placement
a.
Remove the guidewire and sheath from the body.
b.
Close entry wound as appropriate.
NOTE: It is required to use S.M.A.R.T. RADIANZ as the stent delivery system, BRITE TIP RADIANZ as the 
guiding sheath and SABERX RADIANZ as the PTA balloon catheter (if pre-dilation and/or post-dilatation is 
performed) during the index procedure to be able to adequately evaluate the performance of all three (3) 
devices.
Though subjects are considered enrolled only from the time they are confirmed to qualify for study 
participation according to the eligibility criteria (i.e., upon completion of angiography), all events for enrolled 
subjects, which include all adverse events and device deficiencies, will be reported retroactive to when 
vascular access was established in the radial artery (i.e., time of puncture), in the case of adverse events,
or initial use or handling of a study device, in the case of device deficiencies.
11.2
Treatment of Bilateral Stenosis
A patient with bilateral stenosis (lesions in both limbs) can have both lesions treated without a waiting period 
(e.g., during the index procedure). In all cases, a lesion on the second/contralateral limb can ONLY be
treated with the study devices, via transradial approach and if it meets all applicable study eligibility criteria. 
11.3
Treatment Failures
In the event of a device deficiency, detailed information on the product, circumstances of the deficiency as 
well as any complications and their management will be collected and reported to the sponsor, as described 
in Section 13.6.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 41 of 83 
FINAL  
 
Failure to implant the assigned study device will be recorded on the CRF as a treatment failure.  In the 
event of a treatment failure, each site will follow their standard-of-care procedures (and/or use 
commercially-available products) to ensure the safety of the subject.  
Any subject enrolled in this clinical study that does not receive the study device (S.M.A.R.T. stent) will be 
followed to 30 days post-procedure to be monitored for safety (adverse events and overall health) but will 
not be required to complete any of the study-specific procedures/assessments scheduled for the 30-day 
follow-up visit.  
If applicable, the Investigator must return any malfunctioned/damaged/unused
investigational devices to the sponsor or its designee in accordance with the instructions provided.
11.4
Post-Procedure Care/Discharge (+7 days)
Following the index procedure, the site will notify the sponsor of the subject enrollment status (i.e., whether 
the subject was enrolled or was a screen failure).
In addition to the standard-of-care procedures at each participating site, all subjects will undergo these 
assessments at time of discharge (+ 7 days):
1.
Concomitant Medications (recommended):
Post Procedure: Clopidogrel bisulfate (Plavix®)
75 mg qd
or
Ticlopidine (Ticlid®)
250 mg b.i.d.
After Discharge: Aspirin
75-325 mg qd indefinitely
Clopidogrel bisulfate (Plavix®) 
75 mg qd for at least 30 days
or
Ticlopidine (Ticlid®) 
250 mg b.i.d. for at least 30 days
2.
Adverse Event Monitoring
3.
Quality of Life Assessment: SF-36 & EQ-5D
4.
Duplex Ultrasound*: This must be completed of the radial artery that was used as the access 
site during the index procedure.  Refer to the Core Lab reference manual for guidelines on 
performing and submitting this assessment.
If a
-of-care requires additional imaging assessments prior to discharge that are not 
required per the study protocol, copies should be sent to the Core Lab.  
Upon discharge, subjects must be given a Stent Implant Card 
included.
 
* Post-procedure duplex ultrasound can be completed any time between discharge and the 30-day follow-up
visit per standard practice.  If not standard-of-care at the site, this assessment must be completed at 
discharge. 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 42 of 83 
FINAL  
 
11.5
Recommended Medication Regimen
 
Pre-Procedure
Aspirin
AND
Clopidogrel bisulfate (Plavix®)
OR
Ticlopidine (Ticlid®)
75-325 mg (non-enteric coated water 
soluble) starting at least 24 hours prior to 
procedure
Loading dose of 300-375 mg within 24 
hours pre-procedure
Loading dose of 250 mg within 24 hours 
pre-procedure
During Procedure
Heparin (If administered)
Initial bolus IV with additional boluses to 
maintain an activated clotting time (ACT) >
250 seconds
Post-Procedure
Clopidogrel bisulfate (Plavix®)
OR
Ticlopidine (Ticlid®)
75 mg qd
250 mg b.i.d.
After Discharge
Aspirin
AND
Clopidogrel bisulfate (Plavix®)
OR
Ticlopidine (Ticlid®)
75-325 mg qd indefinitely
75 mg qd for at least 30 days
250 mg b.i.d. for at least 30 days
The above medications are NOT required.  An alternative medication regimen that is standard of care at 
the institution may be used instead.  Any medications utilized must adhere to the recommendation specified 
by 
package insert.
11.6
Follow-up Visit/Assessments
Subjects are required to complete the follow-up visit at 30 days (+/- 7 days) post-procedure at the 
investigational site (study institution/office/clinic). The following assessments will be completed at this 
visit:
1.
Concomitant Medications Assessment
2.
Adverse Event Monitoring
3.
Quality of Life Assessment: SF-36 & EQ-5D
NOTE: Please refer to section 11.4 for the requirements and timing of a duplex ultrasound of the radial 
artery to be done post-procedure.
11.7
Telephone/Virtual Follow-Up
The 30-day follow-up visit may be conducted by telephone or other virtual means of communication (i.e., 
audio/video conferencing) ONLY in exceptional circumstances (e.g., due to COVID infection). If the visit 
is conducted by telephone/virtually, concomitant medications, safety information and quality of life 
assessment (SF-36 and EQ-5D) data should be collected from the subject or from a friend/family member,
if possible.  
Every occurrence of a telephone/virtual 30-day follow-up visit will be captured as a protocol deviation with 
an explanation recorded as to why the visit was not completed at the site (e.g., due to COVID infection).  

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 43 of 83 
FINAL  
 
11.8
Lost to Follow-up
For all active subjects, the site must first make three (3) telephone contact attempts to reach the subject for
the 30-day follow-up visit.  If unsuccessful, the Investigator must then send a certified letter to the subject.  
All contact attempts must be adequately 
.  When possible, 
asked for assistance with contacting the subject.   
The subject will be considered lost to-follow-up only under the following circumstances:
The site learns that all methods of contacting the subject are no longer viable (e.g., telephone
number not in service, no forwarding address provided, no current/correct contact information 
The site fails to reach/hear from the subject for the 30-day follow-up visit after all required contact 
attempts have been made using a valid telephone number and address on record.
11.9
Unscheduled Visits
Unscheduled follow-up visits may be required to ensure the safety of study subjects.  All complications and 
adverse events will be evaluated by the Investigator and reported according to sponsor and EC regulations.
If an unscheduled follow-up visit is required, the site study team will assess if the subject has undergone 
any interventional treatment or experienced any adverse events since the last protocol-specified visit and 
will record such information on the appropriate CRF pages. Any additional imaging obtained must be 
forwarded to the Core Lab. All relevant information required to assess any adverse event reported should 
be maintained in the 
records and all relevant documentation required for event 
adjudication should be provided as requested by the sponsor.
Assessments that may be completed at an unscheduled visit include, but are not limited to, the following:
1.
Concomitant medications
2.
Physical examination
3.
Imaging studies
4.
Adverse event monitoring
5.
Quality of Life Assessment: SF-36 & EQ-5D
11.10 Subject Study Exit/Discontinuation
Every subject should be encouraged to remain in the study until they have completed the final, protocol-
required, follow-up visit at 30 +/- 7 days post-procedure.
As required, the investigator(s)/institution(s) will arrange for the care of subjects after their participation in 
the study has ended, per institutional standard-of-care and/or 
best clinical judgement.
If subject participation is prematurely discontinued, the reason for such must be documented
source documents and the CRF.  Possible reasons for 
early exit from the study may include,
but are not limited to, the following:
Withdrawal of consent 
Subject decides to withdraw from the study.  This decision must be 
(i.e., made by the subject). The reason for withdrawal of consent should also 
be inquired from the subject and documented if provided.
Physician discretion 
The Investigator may choose to withdraw a subject from the study for
reasons which include, but are not limited to, safety concerns. A detailed reason for the
withdrawal should be documented.
Death

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 44 of 83 
FINAL  
 
Lost to follow-up
all methods of contacting the subject are no longer viable or the subject is 
unable to be reached, or heard back from, to complete the 30-day follow-up visit
Subjects who discontinue early from the study will not be replaced and cannot re-enter the study.  The 
investigator(s)/institution(s) must arrange for any continued safety monitoring, treatment and/or follow-up 
of subjects who withdraw/are withdrawn from the study or determined as lost to follow-up as per standard-
of-care/best clinical judgement, unless it has been determined by the Investigator that the continued follow-
up may jeopardize the rights, safety, and/or welfare of the subject.  The investigator(s)/institution(s) must 
also maintain traceability of the study device that has been implanted in each of these subjects in the event 
they are to report any safety-related events or complaints attributed to the study device to the sponsor.
11.11 End of Study
The clinical study will be considered complete when the last enrolled subject has completed the 30-day 
follow-up visit or protocol-required assessment or has otherwise exited the study.
The sponsor will provide end-of-study notification to all Member States in which the clinical study was 
conducted within 15 days of the end of the clinical study across all Member States.
12
Core Laboratory 
All sites will be required to submit the duplex ultrasound and baseline angiogram at the time of 
screening/index procedure and any imaging of the same type obtained at other timepoints such as from 
unscheduled visits or per routine, standard-of-care until the time of subject exit, for independent review and 
analysis by a core laboratory.
Instructions for filming technique and film submission will be provided as part of the Study Reference 
Manual.
13
Safety Reporting 
Any person who identifies an event or 
safety has an obligation to inform the Investigator and the sponsor of their concerns.
13.1
Adverse Events
An Adverse Event (AE) is any untoward medical occurrence, unintended disease or injury or any untoward 
clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context 
of a clinical investigation, whether or not related to the investigational device and whether or not anticipated.
Therefore, all anticipated adverse events listed in section 13.2 are included within the scope of overall AE 
reporting requirements.
In this study, the investigational products are:
S.M.A.R.T. RADIANZ 
9 and 10 mm diameters of SABERX RADIANZ  
Though subjects are considered enrolled only from the time they are confirmed to qualify for study 
participation according to the eligibility criteria (i.e., upon completion of angiography), all adverse events for 
all enrolled subjects, 
-
cohort of the study, will be reported retroactive to 
when vascular access was established in the radial artery (i.e., time of puncture) until their exit from the 
study (i.e., point of study completion or premature discontinuation).  Each new AE or change to a previously 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 45 of 83 
FINAL  
 
reported AE (based on any new findings) will be recorded and followed until resolution or stabilization of 
the event or until the subject has exited the study.  
Subjects should be encouraged to report AEs spontaneously and may volunteer information at any time.  
At each evaluation, the Investigator will assess if an adverse event has occurred and will obtain all
information required to complete the appropriate AE CRF(s). If an event occurs at an outside institution, 
the Investigator should obtain all or as much of the required AE information as possible.
For each AE, the Investigator should report at a minimum, the term/description, start/end dates, severity, 
serious/non-serious classification, treatment and outcome of the AE and determine its causality/association 
to the study devices or study procedures. During causality assessment, clinical judgement shall be used 
or the study protocol shall be consulted, 
as all the foreseeable SAEs and the potential risks are listed and assessed there. The presence of 
confounding factors, such as concomitant medication/treatment, the natural history of the underlying
disease, other concurrent illness or risk factors shall also be considered.
The following categorizations will be used when reporting the severity and causality for AEs:
Severity:
Mild:
Awareness of a sign or symptom that does not interfere with the 
usual activity or is transient, resolved without treatment and 
with no sequelae;
Moderate:
Interferes, but does not hinder the 
usual activity and may 
require treatment;
Severe:
Symptom(s) causing severe discomfort and significant impact of the 
usual activity and requires treatment or intervention.  
Causality:
Not related: 
Relationship to the study devices or procedures can be excluded when:
- the event has no temporal relationship with the use of the study devices,
or the procedures related to application of the study devices
- the adverse event does not follow a known response pattern to the medical 
device (if the response pattern is previously known) and is biologically 
implausible;
- the discontinuation of medical device application or the reduction of the
level of activation/exposure, when clinically feasible, and reintroduction of 
its use (or increase of the level of activation/exposure), do not impact on 
the AE;
- the event involves a body-site or an organ that cannot be affected by the 
device or procedure;
- the serious adverse event can be attributed to another cause (e.g., an 
underlying or concurrent illness/ clinical condition, an effect of another 
device, drug, treatment or other risk factors);
- the event does not depend on a false result given by the study device used 
for diagnosis, when applicable;

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 46 of 83 
FINAL  
 
In order to establish the non-relatedness, not all the criteria listed above 
might be met at the same time, depending on the type of device/procedures 
and the AE.
 
Possible: 
The relationship with the use of the study device or the procedures is weak 
but cannot be ruled out completely. Alternative causes are also possible 
(e.g., an underlying or concurrent illness/clinical condition or/and an effect 
of another device, drug or treatment). Cases where relatedness cannot be 
assessed, or no information has been obtained should also be classified as 
possible.
Probable:
The relationship with the use of the study device or the procedures, seems
relevant and/or the event cannot be reasonably explained by another 
cause.
Causal relationship:
The AE is associated with the study device or
procedures beyond reasonable doubt when:
- the AE is a known side 
effect of the product category the device belongs to or of similar devices 
and procedures;
- the AE has a temporal relationship with study device use/application or 
procedures;
- the AE involves a body-site or organ:
o
to which the study devices or procedures are applied;
o
on which the study devices or procedures have an effect; 
- the AE follows a known response pattern to the medical device (if the 
response pattern is previously known);
- the discontinuation of medical device application (or reduction of the level 
of activation/exposure) and reintroduction of its use (or increase of the level 
of activation/exposure), impact on the AE (when clinically feasible);
- other possible causes (e.g., an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug or treatment) have been 
adequately ruled out;
- harm to the subject is due to error in use;
- the AE depends on a false result given by the study devices used for 
diagnosis, when applicable;
 
In order to establish the relatedness, not all the criteria listed above might 
be met at the same time, depending on the type of devices/procedures and 
the AE.
The sponsor and the investigators will distinguish between AEs related to the study devices and those 
related to the procedures (any procedure specific to the clinical investigation). An AE can be related both 
to procedures and the study devices. Complications caused by concomitant treatments not required by the 
study protocol or routine diagnostic or patient management procedures applied to patients regardless of 
the study protocol are considered not related. If routine procedures are not required by the study protocol,
complications caused by them are also considered not related.  In some particular cases, the AE may not 
be adequately assessed because information is insufficient or contradictory and/or the data cannot be 
verified or supplemented. The sponsor and the Investigators will make the maximum effort to define and 
categorize the event and avoid these situations. 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 47 of 83 
FINAL  
 
The sponsor/designee will review/screen source documents during on-site and/or remote interim monitoring 
visits (IMV) to ensure any new adverse events or changes to previously-reported adverse events have been 
reported appropriately by the study site or otherwise, request they be promptly reported.
13.2
Anticipated Adverse Events
The following is a list of anticipated AEs categorized by occurrence (Improbable, Remote, Occasional, 
Probable, Frequent) for S.M.A.R.T. RADIANZ
Vascular Stent System.
Occurrence Rate: Improbable, <0.002%
Abrupt closure
Access failure
Access site complications
Allergic/anaphylactoid 
reaction to anticoagulant 
and/or antithrombotic 
therapy or contrast 
medium
Allergic reaction to nitinol
Allergic reaction
Amputation
Anemia/blood loss
Arrhythmia
Blue toe syndrome
Bradycardia
Worsened claudication or 
rest pain
Death 
Encephalopathy (new or 
worse) (altered mental 
state or confusion)
Fever
Fistulization
Gangrene
Gastrointestinal bleed from 
anticoagulation/antiplatelet 
medication
Hematoma
Hemorrhage
Hypotension/hypertension
Iliac artery spasm
Infection
Infection and/or sepsis
Intimal tear/dissection
Ischemia
Multi-organ failure
Muscle hemorrhage
Pain
Pneumothorax
Pseudoaneurysm
Renal failure
Respiratory arrest
Sepsis
Stent embolization
Stent migration
Stent occlusion
Stroke
Transient Ischemic 
Attack (TIA)
Trauma to adjacent 
structures
Worsened claudication or 
rest pain
Occurrence Rate: Remote, 0.002%-<0.02% 
Aneurysm
Angina/coronary ischemia/myocardial infarction
Arterial restenosis
Arterial stenosis or dissection
Arteriosclerosis
Arteriovenous fistula
Disseminated intravascular coagulation
Edema, peripheral
Embolism
Emergent repeat hospital intervention or surgery
Necrosis
Restenosis of the stented segment
Tissue necrosis
Vascular injury, including perforation, rupture and dissection
Vasospasm
Vessel occlusion/thrombosis, puncture site (restenosis or recurrent stricture)

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 48 of 83 
FINAL  
 
Occurrence Rate: Occasional, 0.02% to <1%
No risks
Occurrence Rate: Probable, 1% to <10% 
No risks
Occurrence Rate: Frequent, >10%
No risks
*All hematoma events should be reported according to the EASY Hematoma Classification System 
presented in Appendix D.
The following is a list of anticipated AEs categorized by occurrence (Improbable, Remote, Occasional, 
Probable, Frequent), for the SABERX RADI
Occurrence Rate: Improbable, <0.002%
Acute Myocardial infarction
Allergic 
reaction 
(device, 
contrast 
medium, and medications)
Amputation
Arrhythmias
Arteriovenous fistula
Bradycardia
Death
Hypotension/ hypertension
Inflammation
Infection / sepsis
Neurological events, including peripheral 
nerve injury, transient ischemic attack, 
and/ or stroke
Organ failure (single, multiple)
Procedural 
complications: 
bleeding, 
hypotension, access site complications
Pseudoaneurysm
Renal failure
Vascular complications (e.g. intimal tear, 
dissection,
pseudoaneurysm, 
perforations, rupture, spasm, occlusion)
Occurrence Rate: Remote, 0.002% to <0.02% 
Abrupt vessel closure
Access site complication
Dissection
Embolism
Hematoma at puncture site
Hemorrhage
Ischemia
Necrosis
Pain
Restenosis of the dilated vessel
Occurrence Rate: Occasional, 0.02% to <1%
Potential for balloon burst and potential complications (rated burst pressure) 
Occurrence Rate: Probable, 1% to <10% 
No risks
Occurrence Rate: Frequent, >10%
No risks

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 49 of 83 
FINAL  
 
*All hematoma events should be reported according to the EASY Hematoma Classification System 
presented in Appendix D.
13.3
Serious Adverse Events
A Serious Adverse Event (SAE) is any AE that led to any of the following:
a)
death
b)
serious deterioration in the health of the subject, that resulted in any of the following:
life-threatening illness or injury;
permanent impairment of a body structure or a body function;
hospitalization or prolongation of existing hospitalization;
medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function;
chronic disease
c) fetal distress, fetal death or a congenital physical or mental impairment or birth defect
The Investigator must report all new SAEs or changes to previously-reported SAEs (based on any new 
findings), with whatever information is available at the time, to the sponsor and/or designee by any 
acceptable method as communicated by them, within 24 hours or one working day of first awareness of the 
event by any member of the site study team and provide any additional information as required by the 
sponsor/designee.  Principally, such events may be reported through the EDC system within 24 hours or 
one working day of first awareness; if this is not possible, the event must still be reported in the EDC system 
as soon as possible. In the case of death, all available information, e.g., autopsy or other post-mortem 
findings, including causality/association to the investigational product, should be provided.  The medical 
monitor of this study will decide if more follow-up information is needed in case the event is not resolved at 
the time of subject exit from the study.
The Investigator or Contract Research Organization (CRO) shall notify the EC of the institution at which 
SAEs occurred (and/or the ECs of other participating institutions) in accordance with institutional 
requirements.  
SAEs will be recorded and followed until resolution or stabilization of the event or until the subject has exited 
the study.  
13.4
Major Adverse Events 
Certain significant SAEs are also classified as Major Adverse Events (MAE).  For this study, an MAE is 
defined as any event which resulted in one of the following:
Death
Index Limb Amputation
Target Lesion Revascularization
The Investigator must report all new MAEs or changes to previously-reported MAEs (based on any new 
findings), with whatever information is available at the time, to the sponsor and/or designee by any 
acceptable method as communicated by them, within 24 hours or one working day of first awareness of the 
event by the study team at the institution and provide any additional information as required by the 
sponsor/designee.  If the event is not reported through the EDC system within this time period, it must be 
done so as soon as possible.  In the case of death, all available information, e.g., autopsy or other post-
mortem findings, including causality/association to the investigational product, should be provided.  The 
medical monitor of this study will decide if more follow-up information is needed in case the event is not 
resolved at the time of subject exit from the study.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 50 of 83 
FINAL  
 
The Investigator or CRO shall notify the EC of the institution at which MAEs occurred (and/or the ECs of 
other participating institutions) in accordance with institutional requirements.  
MAEs will be recorded and followed until resolution or stabilization of the event or until the subject has 
exited the study.  
13.5
Unanticipated Serious Adverse Device Effects 
An Unanticipated Serious Adverse Device Effect (USADE) is a serious AE (adverse effect) related to the 
use of a study device which by its nature, incidence, severity or outcome has not been identified in the 
current risk assessment or any other unanticipated serious problem associated with a study device that 
relates to the rights, safety, or welfare of subjects. Procedures associated with the use of a device should 
be addressed in the risk assessment, which makes it possible to determine whether the procedure-related 
SAEs are USADEs or not. SAEs related to procedures required in this study but not with the use of the 
device should not be considered USADEs.
The Investigator must report all potential new USADEs or changes to previously-reported USADEs (based 
on any new findings), with whatever information is available at the time, to the sponsor and/or designee by 
any acceptable method as communicated by them, within 24 hours or one working day of first awareness 
of the event by the study team at the institution and provide any additional information as required by the 
sponsor/designee.  If the event is not reported through the EDC system within this time period, it must be 
done so as soon as possible.  In the case of death, all available information, e.g., autopsy or other post-
mortem findings, including causality/association to the investigational product, should be provided.  The 
medical monitor of this study will decide if more follow-up information is needed in case the event is not 
resolved at the time of subject exit from the study.
The Investigator or CRO shall notify the EC of the institution at which USADEs occurred (and/or the ECs 
of other participating institutions) in accordance with institutional requirements.
USADEs will be recorded and followed until resolution or stabilization of the event or until the subject has 
exited the study.  
13.6
Device Deficiencies
A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of 
an investigational device, including device malfunction, use errors or inadequacy in information supplied by 
the manufacturer.
A device malfunction is considered a failure of a device to meet any of its performance 
specifications or otherwise perform as intended. Performance specifications include all claims 
made in the 
clinical study protocol.
In the event of a device deficiency, detailed information on the product, circumstances of the deficiency as 
well as any complications and their management will be collected and reported.  
Though subjects are considered enrolled only from the time they are confirmed to qualify for study 
participation according to the eligibility criteria (i.e., upon completion of angiography), all device deficiencies 
for all enrolled subjects, 
-
cohort of the study, will be reported retroactive to 
the initial use or handling of a study device until their exit from the study (i.e., point of study completion or 
premature discontinuation).  
The Investigator must report all new device deficiencies or changes to previously-reported device 
deficiencies (based on any new findings), with whatever information is available at the time, to the sponsor
and/or designee by any acceptable method as communicated by them, within 24 hours or one working day
of first awareness of the event by the study team at the institution and provide any additional information 
as required by the sponsor/designee.  If the event is not reported through the EDC system within this time 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 51 of 83 
FINAL  
 
period, it must be done so as soon as possible.  If applicable, the Investigator must make arrangements for 
the safe return of any malfunctioned, damaged, and/or unused investigational devices in accordance with 
the instructions provided by the sponsor.
13.7
Complaints for CE Marked Product
AEs and device deficiencies that occur with approved (CE marked) product used in accordance with the 
Instructions for Use (i.e., within the scope of its intended use) will be considered as complaints .  In other 
words, complaints for CE marked product are considered the equivalent of AEs and device deficiencies for 
investigational product.
Therefore, the criteria used to categorize all complaints for CE marked 
product by type and the timeframes and methods for recording and reporting each to the sponsor 
will be the same as they apply for all adverse events and device deficiencies reported for
investigational product, as described in sections 13.1 through 13.6 above.
In this study, the CE marked products are:
BRITE TIP RADIANZ
8 mm and smaller diameters of SABERX RADIANZ
Since all sizes of the BRITE TIP RADIANZ device and all sizes of the SABERX RADIANZ device with an 8
mm or smaller diameter are CE marked, the anticipated events associated with use of these devices are
respective IFUs, which will be 
provided by the sponsor.
13.8
Reportable Events
13.8.1 Investigational Product
, which require immediate reporting from the sponsor 
(which can be the manufacturer, the legal representative or another contact person/entity established by 
the sponsor, if accepted by the Member State) to the National Competent Authorities (NCA)):
a) any SAE that has a causal relationship with the investigational devices or the investigation 
procedure or where such causal relationship is reasonably possible;
b) any device deficiency that might have led to an SAE if appropriate action had not been taken, 
intervention had not occurred, or circumstances had been less fortunate;
c) any new findings in relation to any event referred to in points a) and b).
Even if it is not possible to report all new SAEs, MAEs, USADEs, device deficiencies and complaints for 
CE marked product or changes to such previously-reported events to the sponsor by any acceptable 
method within 24 hours or one working day of first awareness of the event by the study team at the 
institution, every effort must be made to ensure all 
still reported to the sponsor no later than three (3) calendar days of first awareness by the study team.
The sponsor will follow the below timelines for notifying NCAs of all reportable events for the investigational 
products used in this study, unless a different timeline or modality is agreed upon between the NCAs and 
sponsor:
For all reportable events which indicate an imminent risk of death, serious injury, or serious illness 
and that require prompt remedial action for other subjects, users or other persons or a new finding 
to it: Immediately, but no later than two (2) calendar days after awareness by sponsor of a new 
reportable event or of new information in relation with an already reported event. This includes 
 
Possible, probable or causal relationship assigned to the SAE by either the sponsor or Investigator

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 52 of 83 
FINAL  
 
events that are of significant and unexpected nature such that they become alarming as a potential 
public health hazard and includes the possibility of multiple deaths occurring at short intervals.
These concerns may be identified by either the NCA or the manufacturer.
Any other reportable events or a new finding/update to it: Immediately, but no later than seven (7)
calendar days following the date of awareness by the sponsor of the new reportable event or of 
new information in relation with an already reported event.
The period for reporting shall take into account, the severity of the event.  Where necessary to ensure timely 
reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report. 
Reportable events will be reported all at the same time to all NCAs where the clinical investigation is 
authorized to start or has commenced.
The reporting method (i.e., use of the Summary Reporting Form) and above reporting timelines, as specified 
in the MDCG 2020-10/1 guidance entitled, 
Investigations of Medical Devices 
(October 2022) will be followed in the process for notifying the NCAs
of all reportable events.
Individual countries may also require separate and similar reporting to the Ethics Committee(s) of
participating institutions in those countries.
13.8.2 CE Marked Product
Any SAE or device deficiency that might have led to an SAE that is related to CE marked product used in 
investigation procedure, in which case the sponsor would follow the same reporting procedures and 
timelines as they apply for investigational product (see section 13.8.1) in addition to following the normal 
vigilance reporting procedures for CE marked product (see section 13.9).
13.9
Post-Market Surveillance and Vigilance
13.9.1 Reporting Serious Incidents and Field Safety Corrective Actions
For the CE marked devices used in this study, the sponsor will report to the relevant NCAs, any serious
incidents or potentially reportable serious incidents involving these devices and any field safety corrective 
actions with respect to these devices and perform a follow-up analysis of such serious incident or field 
safety corrective action (see Section 13.9.3). The period for reporting shall take into account, the severity 
of the event.  Where necessary to ensure timely reporting, the sponsor may submit an initial report that is 
incomplete followed up by a complete report.
The sponsor shall report the serious incident or potentially reportable serious incident immediately, 
and no later than 15 days, upon awareness of the incident and establishing the causal relationship 
between the incident and device or that such causal relationship is reasonably possible.
o Additionally, the sponsor will report a serious public health threat immediately, and no later 
than two (2) days, upon awareness of the threat.
o Additionally, the sponsor will report a death or unanticipated serious deterioration 
state of health immediately, and no later than 10 days, upon awareness of the serious incident
and establishing or suspecting a causal relationship between the device and the serious 
incident.
Except in urgent cases where it is necessary to undertake immediate field safety correction action, 
the sponsor will report the field safety correction action prior to it being undertaken. 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 53 of 83 
FINAL  
 
If agreed upon between the sponsor and NCAs, the sponsor may provide periodic summary 
reports in lieu of individual serious incident reports for similar serious incidents that occur with the 
same device or device type and for which the root cause has been identified or a field safety 
corrective action implemented or for which the incidents are common and well-documented.
If the sponsor considers an incident as NOT a serious incident or as an expected, undesirable side effect 
covered by trend reporting, it will provide an explanatory statement for review and consideration by the 
NCA.  If the statement is not agreed to by the NCA, the sponsor may still be required to report the incident 
and perform a follow-up analysis.
13.9.2 Trend Reporting
For the CE marked devices, the sponsor will report to the NCAs, any statistically significant increase in the 
frequency or severity of non-serious incidents or expected, undesirable side effects that could have 
a significant impact on the benefit-risk analysis (i.e., have led or may lead to risks to the health or safety 
of patients, users or other persons that are unacceptable when weighed against the intended benefits),
when compared to the foreseeable frequency or severity of such incidents during a specific period as per 
the technical documentation and product information. The management of these incidents, methods used 
for determining the statistically significant increase
Post-Market Surveillance Plan. 
13.9.3 Analysis of Serious Incidents and Field Safety Corrective Actions
Following the reporting of a serious incident to the relevant NCAs, the sponsor will immediately perform the 
necessary investigations related to the serious incident and the CE marked devices concerned, which will 
include a risk assessment of the incident and field safety corrective action. Such investigations will NOT 
involve altering the device or a sample of the device lot/batch concerned in a way that may affect any 
subsequent evaluation of the causes of the incident, prior to informing the NCAs of such action. Upon 
request, the sponsor will provide the NCA with any documentation necessary for their conduct of a risk 
assessment. The sponsor will also provide a final report to the NCA with findings and conclusions from the 
investigation and where applicable, the corrective actions to be taken.
The sponsor will ensure that all users of the device in question are immediately notified of all information 
regarding the field safety corrective action taken via a field safety notice that is written in the official 
language(s) of the Member State/country in which the field safety correction action is taken.
Except in 
urgent cases, the sponsor will submit the content of the draft field safety notice to the evaluating NCA (or 
where appropriate, the coordinating NCA) for comments.  The field safety notice will clearly explain, without 
understating the level of risk, the reasons for the field safety corrective action with reference to the device 
malfunction and associated risks for patients, users or other persons, and will clearly indicate all actions to 
be taken by users.
13.10 Risk Assessment and Management
Risks arising during the course of this clinical study will be managed as follows:
1)
Risks will be monitored against established risk acceptability thresholds. 
2)
When concerns have been recognized, a preliminary risk analysis will be performed and documented 
by the sponsor along with the Investigator and other advisors, as appropriate, and can result in one of 
the following outcomes: 
A. The new information is adequately reflected in the existing risk assessment and the individual and 
overall residual risks to subjects, users, or other persons remain acceptable.
B. If a potential, unacceptable risk or serious health threat has been identified, the sponsor will suspend 
the clinical study immediately and notify all interested parties of the preliminary risk analysis while 
making appropriate arrangements for conducting a comprehensive risk assessment per ISO 14971.  
If appropriate, the Data and Safety Management Board (DSMB) (see section 18.1) or other expert 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 54 of 83 
FINAL  
 
advisors will be requested to provide their input into the comprehensive risk assessment, which can 
result in one or more of the following outcomes: 
i.
The new information is adequately reflected in the existing risk assessment and individual and 
overall residual risks to subjects, users or other persons remain acceptable, in which case the
sponsor will ensure a rationale is recorded in the clinical study documentation and necessary 
activities are performed before resuming the clinical study. 
ii. Corrective actions can be applied, including the following:
a. If the corrective actions do not affect the validity of the clinical study, the sponsor will revise 
the benefit-risk analysis to justify continuation of the clinical study and perform necessary 
activities before resuming the clinical study. 
b. If the corrective actions affect the validity of the clinical study, the sponsor will terminate the 
clinical study. 
iii. Corrective actions cannot be applied, in which case the sponsor will terminate the clinical study.
Signals from adverse events or device deficiencies that might indicate a serious health threat can be 
detected by either the sponsor or investigator but are always evaluated by the sponsor.
A formal review of risks will be performed upon completion of this clinical study and incorporated into the 
risk analysis and clinical evaluation and an update of the benefit-risk conclusions made in both documents.
Additionally, the sponsor and/or designee, including but not limited to the clinical project manager, medical 
monitor and representatives from its post-market surveillance (complaint handling) groups will review
information on individual, site-reported adverse events, device deficiencies and complaints and/or periodic 
listings of such events to assess for any trends, identify any new risks, etc. that may impact the safety of 
study subjects.
14
Statistics/Data Analyses
Previous clinical studies of therapeutic Iliac and femoropopliteal artery lesion stent treatments have focused 
on demonstrating the efficacy and safety of the stents under study. As such, the endpoints centered on how 
well the stent improved luminal diameter and any major adverse events associated with the stent treatment. 
There was little if any data captured on the stent delivery systems, or the access artery used in these 
studies.
The primary objective of the RADIANCY study is to evaluate acute safety and efficacy of the S.M.A.R.T. 
TM Guiding Sheath and 
SABERX RADIANZTM PTA Balloon Catheter, in treating patients with obstructive iliac or femoropopliteal 
arterial disease via radial artery access. In other words, the focus of this study is on demonstrating the 
efficacy and safety of the RADIANZ delivery system when using radial artery access (as opposed to femoral 
artery) to deliver the S.M.A.R.T. stent to iliac and femoropopliteal artery lesions (previously approved 
indications for this stent). Therefore, the efficacy and safety endpoints for this study focus on access and 
delivery success and any adverse events associated with access and delivery.  The aim of this study is to 
demonstrate the safety and effectiveness with which the new delivery system can access the radial artery 
to deliver the S.M.A.R.T. stent to obstructive iliac or femoropopliteal lesions.
14.1
Analysis Population
Analyses for the endpoints will be performed using the intent-to-treat (ITT) population. The ITT population 
will consist of all subjects enrolled in the study and for whom a device insertion was attempted, regardless 
of the treatment actually received.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 55 of 83 
FINAL  
 
The per-protocol analysis population is defined as a sub-group of the ITT population consisting of subjects 
without protocol deviations that could possibly affect the primary endpoints.  Primary endpoint analysis 
using this population is supportive in nature.
14.2
Statistical Hypotheses for Endpoints
Effectiveness
The primary efficacy endpoint is technical success at the conclusion of the index procedure defined as 
successful deployment of the study device (S.M.A.R.T.TM stent) at the intended location, and successful 
withdrawal of the delivery system without conversion to femoral access. 
The hypothesis being tested is:
 
Vs 
 
limbs that are successfully treated with one or more 
Vascular Stent Systems.
Safety
The primary safety endpoint is the occurrence rate of device or procedure-related complications associated 
with transradial artery access through the time of hospital discharge. 
The safety hypothesis being tested is:
Vs
f subjects experiencing a radial access related complication. 
14.3
Sample Size Determination
The statistical objective of this study is to assess the efficacy and safety of the primary endpoints. 
Approximately 129 of the 159 subjects enrolled in this study at approximately 15 sites will be included in 
the analyses of the primary safety and efficacy endpoints. The remaining cohort of approximately 30 
subjects (consisting of the first two (2) enrolled subjects at each study site, as applicable) will define the 
-
-
-
and must meet all criteria for enrollment, however, they will be followed up and evaluated to 30 days post-
procedure only for safety and not included in any endpoint analyses.
-
is to enable lesser experienced investigators to gain training/experience with the study procedure and for 
all investigators to become better accustomed to the use of the various study devices.  
The justification for this sample size is as follows:
Efficacy
It is assumed that the technical success rate will be 98%, which is derived from other studies using radial 
access procedures.  The performance goal was also based on a literature review and was set at 93%. 
Using a one-sided exact 95% confidence interval calculated using the Clopper-Pearson method, a sample 
size of 129 limbs provides 88% power to demonstrate that the observed technical success rate is greater 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 56 of 83 
FINAL  
 
than the performance goal of 93%.  Given the acute, in-hospital nature of the endpoint, no adjustment for 
attrition was made.
Safety
It is assumed that the in-hospital device or procedure related radial artery complications will be 2% which 
is derived from other studies using radial access procedures. The performance goal was also based on a 
literature review and was set at 7%. Using a one-sided exact 95% confidence interval calculated using the 
Clopper-Pearson method, a sample size of 129 subjects provides 88% power to demonstrate that the 
observed complication rate is less than the performance goal of 7%. No adjustment for attrition was made.
To adequately assess the efficacy and safety of both iliac and femoropopliteal artery treatment under study 
a minimum of 30 subjects will be required for each artery treatment, i.e., a minimum of 30 iliac and minimum 
of 30 femoropopliteal arteries.
In order to characterize the safety and efficacy of the SABERX RADIANZ device, it is a goal of this study 
to collect information on 30 distinct uses of the device.  This is a goal and not a minimum since use of the 
SABERX RADIANZ device is dictated by the attending physician.  Ideally, the 30 uses will be evenly 
distributed between the iliac and femoropopliteal arteries.
14.4
Statistical Analysis Methods
Except where otherwise specified, the following general principles apply to the planned statistical analyses. 
All descriptive statistical analyses will be performed using SAS version 9.4 or higher, unless otherwise 
noted (SAS Institute Inc., Cary, NC) or other widely accepted statistical or graphical software as required. 
Derived variables will be independently verified by an independent programmer / statistician. 
For categorical variables, the numerator, denominator, rate (%) and exact 95% CI will be calculated. For 
continuous variables, the median, mean, standard deviation, interquartile range, number of observations,
minimum and maximum values, and 95% CI, as appropriate, will be presented. 
For each parameter, the baseline value will be defined as the last non-missing value collected at the time 
closest to but before treatment with the investigational device. 
Statistical tests of the primary endpoints will be performed at the one-sided 0.05 significance level. 
Primary Analysis
Efficacy
A one-sided lower exact 95% CI for technical success rate will be calculated using the Clopper-Pearson 
method. The lower bound will be compared to the performance goal of 93%.  If the lower bound is greater 
than the performance goal then this endpoint will have been successfully achieved.  Technical success is 
defined in section 8.1 above.
This analysis will be done on a per limb basis since some subjects enrolled in the trial have bilateral lesions.  
Each lesion can be treated with up to two stents.  In the case that two stents are used, success is based 
artery, successful deployment of both stents at the intended location and the successful withdrawal of both 
systems with no conversion to femoral access.  While some subjects will present with bilateral lesions, the 
actual number of those subjects will be small.  As such, each limb will be considered an independent 
observation for the purpose of analysis of this endpoint.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 57 of 83 
FINAL  
 
The same analysis will be completed on the per-protocol analysis population if that population is different 
from the ITT population. 
Safety
A one-sided upper exact 95% CI for device or procedure-related radial artery complications rate will be 
calculated using the Clopper-Pearson method. The upper bound will be compared to the performance goal 
of 7%.  If the upper bound is less than the performance goal, then this endpoint will have been successfully 
achieved. Complications related to radial access are defined in section 8.1 above.
Even though some subjects may contribute bilateral lesions, the safety analysis will be analyzed on a per 
subject basis.
The same analysis will be completed on the per-protocol analysis population if that population is different 
from the ITT population. 
Trial success is defined as successful achievement of both the primary efficacy and the primary safety 
endpoints.
14.4.2 Additional Analyses
Secondary endpoints will be summarized using the statistical methods described in section 14.4. No formal 
hypothesis testing will be done on the secondary endpoints.
All secondary safety endpoints will be summarized on a per subject basis.  
The secondary endpoint of technical success of the BRITE TIP RADIANZTM Guiding Sheath will be 
summarized on a per subject basis since the guiding sheath would not be completely removed between 
lesion treatments of a bilateral subject.
Procedural success of the SABERX RADIANZTM PTA Balloon Catheter will be summarized on a per limb 
basis.  In cases where pre-dilation and post-dilatation are performed and/or more than one SABERX balloon
was used to treat a lesion, each device must be successfully inserted into the peripheral vasculature 
through the radial artery, successfully inflated and deflated, and successful withdrawn with the achievement 
of a final residual diameter stenosis of < 30% for the treated lesion.
The additional data points of fluoroscopy time and procedural time, time to achieve hemostasis, time to 
ambulation, time to hospital discharge, time to hospital discharge eligibility, method to achieve closure and 
the scoring of the EQ-5D and SF-36 will be completed on a per subject basis.
Roll-in subjects will be summarized separately and are not part of any endpoint analysis.
A subgroup analysis on the primary endpoints may be performed by artery treated, i.e., iliac and 
femoropopliteal.
14.5
Missing Data
For both primary endpoints, a sensitivity analysis will be done where missing data is imputed using a worst-
case scenario. Specifically, for the efficacy endpoint (technical success), missing data will be imputed as 
radial access-related AE. 
For secondary endpoints, no imputation of missing data is planned since these endpoints are hypothesis-
generating and not being used to expand labeling. Subjects who have ascertainment of status at a later 
out-of-window date (for example, subjects who are known to be free of events past discharge but missed 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 58 of 83 
FINAL  
 
the discharge visit) are not considered missing as their status is known and their data will be used as noted 
previously. 
14.6
Reporting
A final clinical summary (report) will be developed for this study upon completion of all subject follow-up 
visits/database lock for the last required follow-up visit in the study. This final report will be submitted to all 
relevant NCAs within one (1) year of end of study, as described in section 11.11.
A clinical investigation report will be submitted to all relevant NCAs within three (3) months of an early
termination or temporary halt of the study.
This will be provided to the applicable regulatory authorities as well as all participating Investigators and 
eCs.  Interim reports will also be developed and provided only as required.
15
Quality Control and Quality Assurance
15.1
Regulatory and Ethical Compliance
The sponsor maintains a quality management system with written Standard Operating Procedures (SOP)
to ensure that clinical studies are conducted and data are generated, documented and reported in 
compliance with the study protocol and the requirements of ISO 14155:2020, ICH E6 R2 Good Clinical 
Practice, Regulation (EU) 2017/745 (including Annex XIV and Annex XV) and the requirements of all 
applicable regulatory authorities. The staff of Cordis is trained regularly to ensure adherence to these SOPs.
15.2
Data Quality Assurance
Study procedures to ensure the quality of all data collected and analyzed within this study include, but are 
not limited to, the following:
Qualified Investigators, study sites and monitors will be selected.
The investigational devices will be provided to Investigators/sites after being tested and released 
according to appropriate standards.
Training:
o
Training will be provided to and documented for all Investigators and study team, which 
includes, but is not limited to, a review of the protocol, all study devices and the index 
procedure (via a hands-on demonstration using model devices) for the Investigators, CRFs,
EDC system, GCP guidelines and study expectations. This training will be provided at or
around the time of the site initiation visit and prior to the start of any study-related activities
(especially the treatment/enrolment of any study subjects), and as necessary (e.g., when 
there are changes to the study team).
o
Training will be provided to all study monitors on the study protocol, background/therapeutic 
area and GCP-conforming monitoring activities.  Monitors will receive project-specific 
monitoring conventions and all forms needed to document the monitoring activity (e.g., forms 
for monitoring reports, investigational product accountability).
Approximately 30 subjects will be included
oll-
to allow less experienced 
investigators to overcome the learning curve in performing the study procedure and for all investigators
to become better accustomed/acclimated to the operation/use of all study devices through the first 
couple study subjects treated at their respective sites, but without including such subjects in endpoint 
analyses.
Live case support during the study procedure may be provided for the first two (2) subjects enrolled at 
each study site and may be provided for any additional subjects, as deemed necessary.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 59 of 83 
FINAL  
 
The sponsor and/or designee plans to conduct 100% source document verification, as specified in the 
sponsor
, by comparing original source documentation against the CRFs for all 
different types of source data. Any discrepancies identified will be resolved with the Investigator, or 
designee, as appropriate.
Appropriate edit checks incorporated within the EDC system and periodic reviews of the data by Data 
Management will verify the completeness and accuracy of the data.  Similar to the study monitor, Data 
Management will post queries to data points in need of further clarification and/or correction from sites 
and will keep the sponsor study team informed of the status of queries and completeness of the study 
database.
The EDC vendor, Medrio, has policies in place governing data protection, privacy and security
measures that are in compliance with regulations such as 21 CFR Part 11, Annex 11, Good Clinical 
Practice, General Data Protection Regulation (GDPR), CCPA, and HIPAA.
It is expected that all 
investigational sites also have data privacy, protection and security policies and a General Data 
Protection Officer in place.
Professional, independent core laboratories will be used for review and analysis of all site-submitted 
imaging and independent data review committees (Data Safety Monitoring Board and Clinical Events 
Committee) will be used to review aggregate study data and adjudicate certain events at periodic 
intervals.
The laboratory analysis in this trial will be performed by routine techniques of the laboratory of the study 
center. Laboratory certification and normal range values will be obtained from each 
laboratory.
The Investigator must produce/capture, review and maintain all study documents and data (including 
electronic source data) to ensure reliability, integrity, control and traceability.  All documents must be
identifiable, traceable and appropriately stored to provide a complete history of the study.  The accuracy of 
all translations, if applicable, must be documented.  The Investigator must also ensure accuracy, attribution, 
completeness, legibility and timeliness of all study data reported in the CRFs and in all required reports. If
copies of the original source documents are on file, they must be certified via dated signature by a member 
of the study team or generated through a validated process.
The Investigator must ensure all trained study site team members are recorded and tracked via a 
Delegation of Authority log, which will include their names, initials, signatures and roles (functions).
15.3
Clinical Data
The case report form (CRF) for each subject is a record of their eligibility to enter the study, medical history, 
pre-procedure/baseline assessments, concomitant medications, all study devices used during the index 
procedure, all procedural complications, and adverse events as well as data from discharge, follow-up and 
any unscheduled visits.
It is the obligation of each Investigator (or designee) to ensure that all source 
documents (e.g., medical files, clinic charts, diagnostic films, nursing files), are available to support all data 
points collected within the CRF for every screened and/or enrolled subject for verification by the study 
monitor(s).  All information obtained during and between all protocol-required procedures needs to be 
clearly documente
and CRF. A printout of the CRFs CANNOT
be used as source documentation.
Qualified study site team members trained to the protocol, CRFs and EDC system will perform primary data 
collection and data entry into the CRFs in a timely manner following subject enrollment and the completion 
of study-required assessments/follow-up visit at 30 days post-procedure.
Data will be collected from 
subject ' hospital charts, imaging films, and/or other medical records, which the Investigator is responsible 
to ensure are adequate to support all CRF entries.  Corrections to CRFs will be performed by the 
Investigator or other authorized study site personnel.   A record of study site team members authorized to 
perform CRF data entry and/or corrections will be maintained by the site and provided to the sponsor.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 60 of 83 
FINAL  
 
The Investigator must sign and da e th specified section(s) within the CRF to confirm that s/he has reviewed 
the data and that the data are complete and accurate.
15.4
Monitoring
The sponsor (and/or designee) will oversee the conduct and progress of the study at each investigational 
site.  In addition to regular communications with the site, the sponsor will conduct on-site and/or remote 
interim monitoring visits (IMV) at periodic intervals to verify the following:
The rights and well-being of the subjects are protected;
The study is conducted according to International Council of Harmonization (ICH), applicable 
international standards and Good Clinical Practices (GCP) (ICH E6), the Declaration of Helsinki
(1964) amended in Brazil 2013 and all national, state and local laws of the pertinent regulatory 
authorities;
The study is conducted in compliance with all requirements identified within the approved protocol/
amendment(s);
The data reported in the CRFs/EDC system are accurate, complete and verifiable from source 
documentation.
The study monitor will complete verification of the above primarily from review and assessment of regulatory 
documents; signed informed consent forms; accountability, records and storage of investigational product;
and CRF/EDC system entries against all source documents. As mentioned in section 15.2, the sponsor 
monitoring plan, by comparing original source documentation against the CRFs for all different types of 
source data. Additionally, the sponsor/designee will review/screen source documents to ensure any new 
adverse events or changes to previously-reported adverse events have been reported appropriately by the 
study site or otherwise, request they be promptly reported.
The monitor will also post and address queries within the EDC system and discuss the conduct of the study 
with the Investigator and study team.  CRFs would need to be completed in a timely manner, within 5 
working days or 1 week, to ensure availability for IMVs.
Complete details regarding the monitoring 
procedures followed for the study are described in the sponsor
The Investigator must agree to provide study monitors with direct access to the office/clinic/facilities,
medical records/source data/source documents for all enrolled subjects, regulatory documents and any/all 
other applicable study-related documents to enable the proper completion of IMVs.
IMVs will be conducted throughout the course of this study according to the sponsor
The 
IMV frequency is planned to be one IMV conducted approximately every 6-8 weeks during both the 
enrollment phase and acute follow-up period, however, will also be based on factors including, but not 
limited to, the rate and volume of enrollment, the timing of subjects completing follow-up visits and overall 
compliance by the investigational site.
Routine, on-site and/or remote closeout visits (COV) will be scheduled after completion of clinical site 
participation (i.e., all enrolled subjects completed final follow-up assessments as required per the protocol), 
premature discontinuation/termination of a study or site or deemed otherwise appropriate.  They will be 
files are retrieved, all remaining clinical investigation materials are disposed of, previously identified issues 
have been resolved, Inve
notified.  
Monitoring Plan.   

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 61 of 83 
FINAL  
 
15.5
Protocol Modifications
15.5.1 Protocol Amendments
Changes to the research covered by this protocol must be implemented through a formal protocol 
amendment.  Change(s) to only logistical or administrative aspects of the study will be reflected in 
the study protocol if/when it is next amended to address any changes to the research. Protocol 
amendments may be initiated by the sponsor or at the request of the Investigator.  In either case, 
however, all protocol amendments must be approved by the sponsor, signed and dated by the 
Investigator and approved by the respective NCA and EC prior to implementation. Depending on 
the nature of the changes reflected in the amended protocol, amendments to the ICF, CRF and/or 
IB, etc. may also be required with all applicable approvals obtained prior to implementation.
15.5.2 Protocol Deviations/Noncompliance
A protocol deviation is defined as a divergence from a specific element of the study protocol (e.g., 
missed assessment, visit out of window, violation of inclusion/exclusion criteria).  Sites must comply 
with all requirements of the study protocol to control the number of protocol deviations to the extent 
possible.  This does not include circumstances where necessary to eliminate an immediate hazard
to study subjects (see section below) or that involve only logistical or administrative aspects of the 
study.
The study monitor will verify the conduct of the study is in compliance with the currently approved 
protocol at each site and will identify any deviations from the protocol.  The study monitor will also 
determine if there are any other issues of noncompliance (e.g., with EC requirements, regulations 
from applicable regulatory authorities).  If any protocol deviations or other areas of noncompliance 
are noted, the Investigator, site staff and/or study monitor will ensure corrective actions are 
implemented and evaluate the effectiveness of those corrective actions. 
Recurrence of 
noncompliance may require development of a formal corrective action plan that includes a 
suspension in enrollment and/or other actions.  All protocol deviations and other issues of 
noncompliance at a site will be monitored closely by the sponsor and/or designee(s) and will be 
reported to the applicable regulatory authorities and/or the EC, as required.  
No protocol waivers will be issued by the sponsor for this study. 
15.5.3 Emergency Deviations
Emergency deviations would occur only in cases where the change is necessary to eliminate an 
immediate apparent hazard and protect the life or physical well-being of a study subject.  Such cases 
must be reported to the sponsor/Medical Monitor and the EC in writing within five (5) working days
of the occurrence and will still be entered as protocol deviations in the CRF.
15.6
Audits
The sponsor and/or designee and the FDA may contact the participating institution to inform the Investigator 
of an upcoming audit and/or inspection, which may be routine or 
.  In the event the Investigator 
receives notification from FDA of an audit/inspection for this study, the Investigator should immediately 
notify the sponsor.
The Investigator must agree to provide direct access to the office/clinic/facilities, medical records/source 
documents for all enrolled subjects, regulatory documents and any/all other applicable study-related 
documents to all representatives of the sponsor and/or designee and all regulatory authorities to enable 
proper completion of the audit/inspection.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 62 of 83 
FINAL  
 
15.7
Subject Confidentiality and Data Privacy
Subject confidentiality will be maintained throughout the clinical study.  A unique subject identification 
number will be assigned to every enrolled study subject, which will identify all data reported for that subject
and ensure the data can be traced back to their source records.
The Institution and Investigator will conduct the study and test the study devices in accordance with all 
applicable data protection laws, in particular GDPR, to ensure that all legal data protection requirements 
are met in relation to the processing of personal data of study participants.  In particular, the Institution and 
Investigator will provide all study participants with data protection information in accordance with applicable 
data protection law and to obtain data protection-compliant informed consent from the study participants.
Data relating to the study may be made available to all representatives of the sponsor and/or designee and 
third parties (e.g., in the case of an audit performed by regulatory authorities), provided the data are treated 
in accordance with all applicable data protection 
laws, in particular GDPR.
The EDC system used in this study will capture data reported by sites and other entities that will be sent 
outside of the geographic region (Europe) in which the study is being conducted. 
The results of the study may be published in a medical book or journal or presented at meetings, however, 
neither subject names nor any other personal health information that specifically identifies them will be used 
in those publications or presentations.
15.8
Ethics Committee (EC)
Prior to study initiation, the protocol, informed consent form and all other applicable study-related 
documents, including any written materials to be provided to subjects must be submitted for review by a
certified EC. Written approval or favorable opinion of these documents must be obtained and submitted to 
the sponsor prior to screening and enrolling any subjects and initiating any study-related activities.
The Investigator will prepare the draft informed consent form (ICF) and provide to the sponsor and/or 
designee for approval prior to submission to the EC. If the sponsor requires any changes, a revised draft 
of the ICF incorporating these changes must be approved by the sponsor prior to EC submission.  If the 
EC requires additional changes, these must be reviewed and approved by the sponsor prior to resubmission 
to the EC. Copies of the final, EC-approved ICF and all other EC-approved study documents must be 
submitted to sponsor or designee.
The Investigator or authorized designee will promptly report all changes in research activity and all 
unanticipated events/issues involving risks to human subjects to the EC.  All sponsor-approved 
amendments to the study protocol, ICF, etc. must be approved by the EC prior to implementation.  All other 
changes to research activities must be approved by the sponsor and EC prior to implementing, except when 
necessary to eliminate an immediate apparent hazard to the subject.   
If applicable, at least annually, or more frequently if required by EC policy, the Investigator or authorized 
designee must submit a study progress report to their EC to obtain continuing review approval for the study
prior to the expiration of the most recent approval.  Additionally, the Investigator must provide notification 
to their EC, within three (3) months following the completion, termination, or discontinuation of the study at 
the specific site and provide the acknowledgement letter from the EC to the sponsor.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 63 of 83 
FINAL  
 
16
Record Keeping/Publication Policy
16.1
Record Retention
All study records (e.g. correspondence, regulatory documents, CRFs and all source documents, informed 
consent forms, laboratory reports, progress notes, medical histories, physical and diagnostic findings, 
diagnoses, procedure/assessment dates and investigational product disposition records, etc. that support 
the CRFs) must be retained in the files of the responsible Investigator at the study institution for the retention 
period required by applicable local laws.
All study records must be accessible upon request by the applicable regulatory authorities, the sponsor
and/or designee until destruction is possible. The sponsor will notify each Investigator in the study as 
to when records destruction is possible according to the applicable local laws, unless a longer 
retention period is required per institutional requirements.
If the Investigator retires, relocates, or for other reasons, withdraws from assuming primary responsibility 
for keeping the study records, written notice (transfer of obligation) must be submitted to the sponsor and 
EC indicating the name and address of the new custodian accepting primary responsibility.  
16.2
Use of Information and Publications
All information concerning the sponsor (Cordis US Corp.), the study devices, patent application, 
manufacturing processes, and scientific data supplied by the sponsor to the Investigator and not previously 
published, is considered confidential and remains the sole property of the sponsor.
The Investigator 
understands the information developed in the clinical study will be used by the sponsor to prepare a clinical 
study report (CSR)/clinical investigational report in connection with a regulatory submission and thus may 
be disclosed as required to other Investigators or government regulatory authorities.
At the conclusion of the study, a manuscript may be prepared for publication of results across multiple study 
centers in a reputable scientific journal. The publication of the principal results from any single study center 
is not allowed until the preparation and publication of the multi-center results.  Exceptions to this rule require 
prior approval of the sponsor.
The analysis of pre-specified and non-pre-specified endpoints will be 
performed by the sponsor and/or designated entity(-ies) for data management and/or statistics.  Secondary 
analyses as well as other proposed investigations will require the approval of the sponsor.  For purposes 
of timely abstract presentation and publication, secondary publications will be delegated to the appropriate 
principal authors.
17
Product Accountability 
17.1
Product Accountability
Both investigational and CE marked products will be used in this clinical study.  
All sizes of the S.M.A.R.T. RADIANZ device and all SABERX RADIANZ units with 9 and 10 mm 
diameters are investigational
All other sizes (8 mm and smaller diameters) of the SABERX RADIANZ device and all sizes of the 
BRITE TIP RADIANZ device are CE marked and will therefore not have the investigational use 
label.  Both CE marked products, however, are currently NOT commercially available in Europe
and are being made available exclusively for use in this clinical study.
All product for this clinical study must be kept in a secure location with restricted access to authorized 
members of the study team and stored according to the conditions outlined in the Instructions for Use (IFU)

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 64 of 83 
FINAL  
 
and/or Investigator Brochure (IB) for each product.  All product is intended solely for use by the Investigator 
or Sub-Investigator(s) and in subjects of this clinical study.
Accountability for all products will include tracking of all units from point of shipment to the investigational 
sites through point of final disposition and verifying the presence and completeness of all documentation 
supporting product accountability and inventory of product.
Documentation is to be maintained for all 
investigational and CE-marked product supplied for this study and includes, but is not limited to, the 
following:
Packing slips provided with each product shipment.
An up-to-date, complete and accurate product accountability log, separately maintained for each 
product, (or equivalent) showing receipt, use and final disposition of every unit shipped to the site.
Copies of product malfunction forms (or equivalent) for the return of devices for which there was a 
malfunction reported.
Copies of product return forms (or equivalent) for the return of unused or expired devices.
All other device accountability records including source documents and/or package labels of 
product used in study subjects, shipping labels, delivery confirmations, etc.
The Investigator and/or authorized designee will maintain adequate records of the receipt, use, and final 
disposition of all products as required by protocol and applicable country, local and federal regulations. 
All product in this clinical study may be inventoried during on-site visits to ensure there is an adequate 
supply available for use at each site throughout the study.
All product that is opened/used will be accounted for in the CRFs. All AEs, device deficiencies and other 
product issues must also be recorded in the CRFs.
17.2
Instructions for Return of Investigational Products
The sponsor will provide instructions to all sites on the re-package and return of all products not used in 
subjects in this clinical study, the appropriate form(s) (or equivalent) that must be completed and the 
address(es) to which the product must be returned based on whether it is opened/unopened and unused, 
expired, damaged, mislabeled, a product complaint or malfunction has occurred or study enrollment has 
been completed. 
18
Committees
18.1
Data and Safety Monitoring Board 
The DSMB is a body of professionals (primarily comprised of physicians, a biostatistician, and/or a medical 
ethicist) which reviews overall study data at intervals pre-determined before the start of the study and/or 
based on subject enrollment accrual and/or event accrual to assess progress and identify any safety 
concerns or other issues. The DSMB is independent of the sponsor, the investigational sites or anyone 
otherwise involved in the conduct of the study.  Members will not have any scientific, financial or other 
conflict of interest related to the sponsor or the study Investigators.
Information in safety reports provided to the DSMB will include, but not be limited to, all serious, major and 
reportable adverse events; unanticipated serious adverse device effects, device deficiencies and events 
related to the primary safety endpoint.
The DSMB will be responsible for providing to the sponsor, minutes of their meetings and any 
recommendations regarding early termination, suspension or modifications to the study, if the safety and 
well-being of the subjects is in jeopardy.  Any formal statistical rules for terminating or recommending 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 65 of 83 
FINAL  
 
termination of the study will be determined by the DSMB, as applicable.
A memo summarizing the 
outcomes and/or any recommendations from the DSMB will be provided to all investigational sites after 
each DSMB meeting.
The structure and function of the DSMB will be documented in the DSMB Charter.
18.2
Clinical Events Committee
The Clinical Events Committee (CEC) is responsible for the review and final adjudication of a specific list 
of adverse events using source documents provided by sites, upon request, against a set of criteria to 
categorize clinical events and clinical endpoints in the study.  The CEC will establish study-related 
guidelines for the requisite source data and the algorithm followed in order to classify a clinical event 
(according to the study definition).  The sponsor will review the definitions prior to the start of the 
adjudication process.
The CEC will consist of qualified physicians with the appropriate expertise for the type of investigational 
product or condition under study.  Similar to the DSMB, the CEC is also an independent body, functioning 
separately from the sponsor, the investigational sites or anyone otherwise involved in the conduct of the 
study or the clinical care of study subjects.  Members will not have any scientific, financial or other conflict 
of interest related to the sponsor or the study Investigators. As appropriate, members of the CEC will be 
blinded to the primary results of the trial.
The CEC will be responsible for providing adjudication results and minutes of their meetings to the sponsor
for internal review.  
The structure and function of the CEC will be documented in the CEC Charter.
18.3
Early Study Termination or Suspension
The sponsor, DSMB, regulatory authorities or the Investigator may choose to temporarily suspend or
prematurely terminate the study if the safety and well-being of the subjects is in jeopardy (e.g., if there is 
an unacceptable risk or serious health threat).
The sponsor reserves the right to temporarily suspend or prematurely terminate this study either at a single 
site, multiple sites or across all sites at any time for reasons including, but not limited to:
Safety or ethical issues
e.g., if in the opinion of the Investigator, the incidence and/or severity of 
device deficiencies or adverse events in the study caused by treatment with the investigational 
product indicates a potential health hazard 
Inaccurate or incomplete reporting of data
Non-compliance
Unsatisfactory enrollment with respect to quality or quantity
Technical reasons (e.g., change in personnel)
If the sponsor prematurely terminates or temporarily suspends the study, they will promptly notify the 
applicable Investigator(s)/institution(s) and the regulatory authority(ies) of the termination or suspension 
and the reason(s) for such, in accordance with applicable regulatory requirement(s).  The applicable EC(s) 
should also be informed and provided with the reason(s) for termination or suspension by the sponsor or
by the Investigator(s)/institution(s), in accordance with applicable regulatory requirement(s).  In addition, 
the sponsor will provide direction on the return of all unused investigational product and other study 
materials. 
The sponsor will inform the Member State in which the clinical study was conducted within 15 days of the 
date of early termination or temporary suspension (or within 24 hours if done for safety reasons).

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 66 of 83 
FINAL  
 
If the Investigator terminates or suspends the study without prior agreement with the sponsor, he/she will 
promptly provide all details to the institution, the sponsor, and the EC.
If the EC terminates or suspends the study, the Investigator will promptly inform the sponsor with written 
explanation.
In all cases, the investigator(s)/institution(s) must arrange for any continued safety monitoring, treatment 
and/or follow-up of subjects as per standard-of-care/best clinical judgement, unless it has been determined 
by the Investigator that the continued follow-up may jeopardize the rights, safety, and/or welfare of the 
subject.Subject enrollment may be paused or terminated early if the sponsor or DSMB determines that the 
potential benefits of the investigational product/procedure are unlikely to outweigh the risks.  For example, 
if the probability of achieving the target primary endpoint falls below a certain threshold, the study will be 
stopped or paused for re-evaluation.
19
Bibliography
1.
Posham, R. e. (2018). Radial Access for Lower Extremity Peripheral Arterial Interventions: Do We 
Have the Tools? Seminars in Interventional Radiology, 35(5).
2.
Kwon, Y. e. (2018, November). Predictions for Transradial Access Capabilities in the Near Future. 
Endovascular Today, 17(11).
3.
Lodha, A. e. (2021). Transradial Endovascular Intervention: Results from the Radial Access for 
Navigation to your Chosen Lesion for Peripheral Vascular Intervention (REACH PVI) Study. 
Cardiovasc Revasc Med.
4.
Cortese, B. e. (2014). Safety and Feasibility of Iliac Endovascular Interventions with a Radial 
Approach. International Journal of Cardiology, 175, 280-284.
5.
Bunte MC, Cohen DJ, Jaff MR, Gray WA, Magnuson EA, Li H, et al. Long-term clinical and quality of 
life outcomes after stenting of femoropopliteal artery stenosis: 3-year results from the STROLL study. 
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac 
Angiography & Interventions. 2018;92(1):106-14.
6.
Duda, S. H., Bosiers, M., Lammer, J., Scheinert, D., Zeller, T., Oliva, V., . . . Beregi, J. P. (2006). 
Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial 
femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther, 13(6), 701-710. 
doi:10.1583/05-1704.1.
7.
Garriboli L, Miccoli T, Pruner G, Jannello AM. PTA and Stenting of Femoropopliteal Trunk With 
Cordis Smartflex Stent System: A Single-Center Experience. Vascular and endovascular surgery. 
2020;54(1):17-24.
8.
Gray, E. A., Feiring, A., Cioppi, M. , Hibbard, R., Gray, B., Khatib, Y., Jessup, D., Bachinsky, W., 
Rivera, E., Tauth, J., Patarca, R., Massaro, J., Stoll, H. P., & Jaff, M. R. (2015). S.M.A.R.T. Self-
expanding nitinol stent for the treatment of atherosclerotic lesions in the superficial femoral artery 
(STROLL): 1-Year Outcomes. J Vasc Interv Radiol; 26: 21-28
9.
Iida, O., Soga, Y., Hirano, K., Okamoto, S., Dohi, T., Uematsu, M., Yokoi, H., Nobuyoshi, M., 
Muramatsu, T., Fujita, M., Nanto, S., & Nagata, S. (2011). Retrospective multicentre analysis of 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 67 of 83 
FINAL  
 
S.M.A.R.T. vs Luminexx nitinol stent implantation for superficial femoral artery lesions (REAL SL) 
registry. Circ, 75, 421-427
10. Iida O, Urasawa K, Komura Y, Soga Y, Inoue N, Hara H, et al. Self-Expanding Nitinol Stent vs 
Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data 
From the SM-01 Trial. Journal of endovascular therapy an official journal of the International Society 
of Endovascular Specialists. 2019;26(2):158-67.
11. Jagic, N., Stamenkovic, D., Toncev, S., Petrovic, D., Miloradovic, V., & Milicic, B. (2008). S.M.A.R.T. 
control stents in femoropopliteal region. Vojnosanit Pregl, 65(12), 87.
12. Matsumi, J., Tobita, K., Shishido, K., Mizuno, S., Yamanaka, F., Murakami, M., Tanaka, Y., Takahasi, 
S., Akasaka, T., & Saito, S. (2016). Long-term outcomes of S.M.A.R.T. implantation in patients with 
femoro-popliteal disease. Catheterization Cardiovasc Interv, 88, 832-841
13. Schlager, O., Dick, P., Sabeti, S., Amighi, J., Mlekusch, W., Minar, E., & Schillinger, M. (2005). Long-
segment SFA stenting--the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J
Endovasc Ther, 12(6), 676-684. doi:10.1583/05-1672.1.
14. Suzuki, K., Iida, O., Soga, Y., Hirano, K., Inoue, N., Uematsu, M., . . . Meguro, T. (2011). Long-term
results of the S.M.A.R.T. Control(TM) stent for superficial femoral artery lesions, J- S.M.A.R.T. 
registry. Circ J, 75(4), 939-944.
15. Brodmann, M., et al., Clinical Outcomes of Ambulatory Endovascular Treatment Using 4-French and 
6-French Femoral Access Strategies: The Bio4amb Multicentre Trial. Cardiovasc Intervent Radiol, 
2021. 44(5): p. 689-697.
16. Falkowski, A., H. Bogacki, and M. Szemitko, Assessment of Mortality and Factors Affecting Outcome 
of Use of Paclitaxel-Coated Stents and Bare Metal Stents in Femoropopliteal PAD. J Clin Med, 2020. 
9(7).
17. Geraghty, P.J., et al., Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack 
Endovascular System in Below-the-Knee Arteries (TOBA II BTK). Journal of Endovascular Therapy, 
2020. 27(4): p. 626-636.
18. Lin, Y., et al., Mid-term outcomes of endovascular treatment and risk factors for recurrence in patients 
with Trans-Atlantic-Inter-Society II C/D femoropopliteal lesions. Quant Imaging Med Surg, 2021. 
11(5): p. 2028-2039.
19. Rigatelli, G., et al., Impact of number of run-off vessels on interwoven nitinol mesh stents patency in 
the femoropopliteal segment. J Geriatr Cardiol, 2020. 17(9): p. 561-565.
20. Stricker, H., et al., Stent-Assisted Angioplasty (SAA) at the Level of the Common Femoral Artery 
Bifurcation: Long-Term Outcomes. Cardiovasc Intervent Radiol, 2020. 43(4): p. 541-546
21. Biagioni, R.B., et al., Comparison of Bypass and Endovascular Intervention for Popliteal Occlusion 
with the Involvement of Trifurcation for Critical Limb Ischemia. Ann Vasc Surg, 2020. 63: p. 218-226

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 68 of 83 
FINAL  
 
22. D'Archambeau O. 4-French-compatible endovascular material is safe and effective in the treatment of 
femoropopliteal occlusive disease: results of the 4-EVER trial. J Endovasc Ther. 2013 Dec;20(6):746-
56. doi: 10.1583/13-4437MR.1. PMID: 24325689.
23. Deloose, K., et al., Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal 
Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial. J Endovasc 
Ther, 2020. 27(6): p. 936-945.
24.
ly patients with peripheral arterial disease. 
Turkish Journal of Vascular Surgery, 2020. 29(3).
25. Nguyen, D.T., et al., Mid-term results and predictors of restenosis in patients undergoing 
endovascular therapy for isolated popliteal artery steno-occlusive disease. Imaging, 2021. 13(1): p. 
69-75.
26. Ruffino, M.A., et al., Prognostic risk factors for loss of patency after femoropopliteal bailout stenting 
with dual-component stent: results from the TIGRIS Italian Multicenter Registry. Radiol Med, 2021. 
126(8): p. 1129-1137.
27.
Efficacy analysis. Turkish Journal of Thoracic and Cardiovascular Surgery, 2021. 29(1): p. 5.
28. Sigl, M., et al., Lesion Revascularisation subsequent to femoropopliteal spot stenting using the multi-
LOC stent delivery system. in vivo, 2020. 34(1): p. 433-439.
29. Stahlberg, E., et al., Post-dilatation of an interwoven nitinol stent using a paclitaxel-coated balloon for 
revascularization of complex femoro-popliteal lesions. Cardiovascular Intervention and Therapeutics, 
2021. 36(3): p. 338-346.
30. Armstrong EJ, Jeon-Slaughter H, Kahlon RS, Niazi KA, Shammas NW, Banerjee S. Comparative 
Outcomes of Supera Interwoven Nitinol vs Bare Nitinol Stents for the Treatment of Femoropopliteal 
Disease: Insights From the XLPAD Registry. Journal of endovascular therapy : an official journal of 
the International Society of Endovascular Specialists. 2019:1526602819885652.
31. Bosiers, M., Deloose, K., Callaert, J., Moreels, N., Keirse, K., Verbist, J., & Peeters, P. (2011). 
Results of the Protege EverFlex 200-mm-long nitinol stent (ev3) in TASC C and D femoropopliteal 
lesions. J Vasc Surg, 54(4), 1042-1050. doi:10.1016/j.jvs.2011.03.272.
32. Bosiers, M., Peeters, P., Tessarek, J., Deloose, K., Strickler, S., & Zilver, P. T. X. S.-A. S. I. (2013). 
The Zilver(R) PTX(R) Single Arm Study: 12-month results from the TASC C/D lesion subgroup. J
Cardiovasc Surg (Torino), 54(1), 115-122.
33. Brescia, A. A., Wickers, B. M., Correa, J. C., Smeds, M. R., & Jacobs, D. L. (2015). Stenting of 
femoropopliteal lesions using interwoven nitinol stents. J Vasc Surg, 61(6), 1472-1478. 
doi:10.1016/j.jvs.2015.01.030.
34. Chan, Y. C., Cheng, S. W., Ting, A. C., & Cheung, G. C. (2014). Primary stenting of femoropopliteal 
atherosclerotic lesions using new helical interwoven nitinol stents. J Vasc Surg, 59(2), 384-391. 
doi:10.1016/j.jvs.2013.08.037.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 69 of 83 
FINAL  
 
35. Davaine, J. M., Azema, L., Guyomarch, B., Chaillou, P., Costargent, A., Patra, P., . . . Goueffic, Y. 
(2012). One-year clinical outcome after primary stenting for Trans-Atlantic Inter-Society Consensus 
(TASC) C and D femoropopliteal lesions (the STELLA "STEnting Long de L'Artere femorale 
superficielle" cohort). Eur J Vasc Endovasc Surg, 44(4), 432-441. doi:10.1016/j.ejvs.2012.07.015.
36. de Boer SW, de Vries J, Werson DA, Fioole B, Vroegindeweij D, Vos JA, et al. Drug coated balloon 
supported Supera stent versus Supera stent in intermediate and long-segment lesions of the 
superficial femoral artery: 2-year results of the RAPID Trial. The Journal of cardiovascular surgery. 
2019;60(6):679-85.
37. de Boer SW, van den Heuvel DAF, de Vries-Werson DAB, Vos JA, Fioole B, Vroegindeweij D, et al. 
Short-term Results of the RAPID Randomized Trial of the Legflow Paclitaxel-Eluting Balloon With 
Supera Stenting vs Supera Stenting Alone for the Treatment of Intermediate and Long Superficial 
Femoral Artery Lesions. Journal of endovascular therapy : an official journal of the International 
Society of Endovascular Specialists. 2017;24(6):783-92.
38. Dias-Neto M, Matschuck M, Bausback Y, Banning-Eichenseher U, Steiner S, Branzan D, et al. 
Endovascular Treatment of Severely Calcified Femoropopliteal Lesions Using the "Pave-and-Crack" 
Technique: Technical Description and 12-Month Results. Journal of endovascular therapy : an official 
journal of the International Society of Endovascular Specialists. 2018;25(3):334-42.
39. Dumantepe, M., Seren, M., Fazliogullari, O., Ayoglu, U., & Teymen, B. (2015). Treatment of complex 
atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: Midterm 
results. Vascular. doi:10.1177/1708538114568884.
40. Ferreira, M., Lanziotti, L., Monteiro, M., Abuhadba, G., Capotorto, L. F., Nolte, L., & Fearnot, N.
(2007). Superficial femoral artery recanalization with self-expanding nitinol stents: long-term follow-up 
results. Eur J Vasc Endovasc Surg, 34(6), 702-708. doi:10.1016/j.ejvs.2007.07.025.
41. Garcia, L., Jaff, M. R., Metzger, C., Sedillo, G., Pershad, A., Zidar, F., . . . Investigators, S. T. (2015). 
Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries: 
Twelve-Month Results of the SUPERB Trial. Circ Cardiovasc Interv, 8(5). 
doi:10.1161/CIRCINTERVENTIONS.113.000937.
42. Han D, Kang SH, Kim SH, Yoon CH, Chae IH. Comparison of patency between two different 
peripheral self-expandable stents, absolute Pro(R) versus complete SE(R) in femoropopliteal 
occlusive disease. International angiology : a journal of the International Union of Angiology. 
2019;38(4):305-11.
43. Iida, O., Soga, Y., Hirano, K., Okamoto, S., Dohi, T., Uematsu, M., Yokoi, H., Nobuyoshi, M., 
Muramatsu, T., Fujita, M., Nanto, S., & Nagata, S. (2011). Retrospective multicentre analysis of 
S.M.A.R.T. vs Luminexx nitinol stent implantation for superficial femoral artery lesions (REAL SL) 
registry. Circ, 75, 421-427
44. Laird, J. R., Jain, A., Zeller, T., Feldman, R., Scheinert, D., Popma, J. J., . . . Complete, S. E. I. 
(2014). Nitinol stent implantation in the superficial femoral artery and proximal popliteal artery: twelve-
month results from the complete SE multicenter trial. J Endovasc Ther, 21(2), 202-212.
doi:10.1583/13-4548R.1.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 70 of 83 
FINAL  
 
45. Laird JR, Zeller T, Loewe C, Chamberlin J, Begg R, Schneider PA, et al. Novel Nitinol Stent for 
Lesions up to 24 cm in the Superficial Femoral and Proximal Popliteal Arteries: 24-Month Results
From the TIGRIS Randomized Trial. Journal of endovascular therapy : an official journal of the 
International Society of Endovascular Specialists. 2018;25(1):68-78.
46. Lucatelli P, Cini M, Tommasino G, Benvenuti A, Guaccio G, Bascetta S, et al. Use of the Gore Tigris 
Vascular Stent in Advanced Femoropopliteal Peripheral Arterial Disease. Journal of vascular and 
interventional radiology : JVIR. 2018;29(5):614-22.
47. Matsumura, J. S., Yamanouchi, D., Goldstein, J. A., Pollock, C. W., Bosiers, M., Schultz, G. A., . . . 
Rocha-Singh, K. J. (2013). The United States StuDy for EvalUating EndovasculaR TreAtments of 
Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege Everflex NitInol 
STent SYstem II (DURABILITY II). J Vasc Surg, 58(1), 73-83 e71. doi:10.1016/j.jvs.2012.12.066.
48. Miura T, Miyashita Y, Soga Y, Hozawa K, Doijiri T, Ikeda U, et al. Drug-Eluting Versus Bare-Metal 
Stent Implantation With or Without Cilostazol in the Treatment of the Superficial Femoral Artery. 
Circulation Cardiovascular interventions. 2018;11(8):e006564.
49. Montero-Baker, M., Ziomek, G. J., Leon, L., Gonzales, A., Dieter, R. S., Gadd, C. L., & Pacanowski, 
J. P., Jr. (2016). Analysis of endovascular therapy for femoropopliteal disease with the Supera stent. 
J Vasc Surg, 64(4), 1002-1008. doi:10.1016/j.jvs.2016.04.053.
50. Myint, M., Schouten, O., Bourke, V., Thomas, S. D., Lennox, A. F., & Varcoe, R. L. (2016). A Real-
World Experience With the Supera Interwoven Nitinol Stent in Femoropopliteal Arteries: Midterm 
Patency Results and Failure Analysis. J Endovasc Ther, 23(3), 433-441. 
doi:10.1177/1526602816639543.
51. Ohki, T., Angle, J. F., Yokoi, H., Jaff, M. R., Popma, J., Piegari, G., . . . investigators, O. (2016). One-
year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of 
superficial femoral artery disease (OSPREY study). J Vasc Surg, 63(2), 370-376 e371. 
doi:10.1016/j.jvs.2015.08.093.
52. Ruef, J. (2009). One-year follow-up after implantation of the EverFlex nitinol stent in long lesions of 
the superficial femoral artery. Angiology, 60(1), 31-35. doi:10.1177/0003319708317336.
53. San Norberto EM, Flota CM, Fidalgo-Domingos L, Taylor JH, Vaquero C. Real-World Results of 
Supera Stent Implantation for Popliteal Artery Atherosclerotic Lesions: 3-Year Outcome. Annals of 
vascular surgery. 2020;62:397-405.
54. Scheinert, D., Grummt, L., Piorkowski, M., Sax, J., Scheinert, S., Ulrich, M., . . . Schmidt, A. (2011). A 
novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-month results of 
the SUPERA SFA registry. J Endovasc Ther, 18(6), 745-752. doi:10.1583/11-3500.1.
55. Schlager, O., Dick, P., Sabeti, S., Amighi, J., Mlekusch, W., Minar, E., & Schillinger, M. (2005). Long-
segment SFA stenting--the dark sides: in-stent restenosis, clinical deterioration, and stent fractures. J
Endovasc Ther, 12(6), 676-684. doi:10.1583/05-1672.1.
56. Schulte, K. L., Kralj, I., Gissler, H. M., Bagnaschino, L. A., Buschmann, I., Pernes, J. M., . . . Langhoff, 
R. (2012). MISAGO 2: one-year outcomes after implantation of the Misago self-expanding nitinol 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 71 of 83 
FINAL  
 
stent in the superficial femoral and popliteal arteries of 744 patients. J Endovasc Ther, 19(6), 774-
784. doi:10.1583/JEVT-12-3861MR.1.
57. Stavroulakis, K., Torsello, G., Manal, A., Schwindt, A., Hericks, C., Stachmann, A., . . . Bisdas, T. 
(2016). Results of primary stent therapy for femoropopliteal peripheral arterial disease at 7 years. J
Vasc Surg, 64(6), 1696-1702. doi:10.1016/j.jvs.2016.05.073.
58. Stone, P. A., Campbell, J. E., Fischer, R., Phang, D., Thompson, S. N., Dippel, N., & Mousa, A. 
(2015). Early results with LifeStent implantation in RESILIENT and non-RESILIENT inclusion criteria 
patients. Vascular, 23(3), 225-233. doi:10.1177/1708538114545109.
59. Teymen B, Akturk S, Akturk U, Tdjani M. Comparison of drug-eluting balloon angioplasty with self-
expanding interwoven nitinol stent deployment in patients with complex femoropopliteal lesions. 
Vascular. 2018;26(1):54-61.
60. Tsujimura T, Iida O, Fujita M, Masuda M, Okamoto S, Ishihara T, et al. Two-year Clinical Outcomes 
Post Implantation of Epic(TM) Self-Expanding Nitinol Stents for the Aortoiliac Occlusive Disease in 
Patients with Peripheral Arterial Disease. Journal of atherosclerosis and thrombosis. 2018;25(4):344-
9.
61. Vent PA, Kaladji A, Davaine JM, Guyomarch B, Chaillou P, Costargent A, et al. Bare Metal Versus 
Paclitaxel-Eluting Stents for Long Femoropopliteal Lesions: Prospective Cohorts Comparison Using a 
Propensity Score-Matched Analysis. Annals of vascular surgery. 2017;43:166-75.
62. Werner M, Gomari-Grisar F, Belalcazar S, Hirschl M, Kalchhauser G, Al-Taiee B, et al. Prospective 
Evaluation of the TIGRIS Vascular Stent Within a Modern Treatment Algorithm. Journal of 
endovascular therapy : an official journal of the International Society of Endovascular Specialists. 
2019;26(5):637-42.
63. Werner, M., Piorkowski, M., Thieme, M., Nanning, T., Beschorner, U., Rastan, A., . . . Scheinert, D. 
(2013). SUMMIT registry: one-year outcomes after implantation of the EPIC self-expanding nitinol 
stent in the femoropopliteal segment. J Endovasc Ther, 20(6), 759-766. doi:10.1583/13-4430R.1.
64. Zeller, T., Tiefenbacher, C., Steinkamp, H. J., Langhoff, R., Wittenberg, G., Schluter, M., . . . 
Krankenberg, H. (2008). Nitinol stent implantation in TASC A and B superficial femoral artery lesions: 
the Femoral Artery Conformexx Trial (FACT). J Endovasc Ther, 15(4), 390-398. doi:10.1583/08-
2461.1.
65. Kishida, T., et al., The feasibility of the flower stenting technique for ostial lesions of the common iliac 
artery. Health Sci Rep, 2021. 4(3): p. e343.
66. Iida, O., Soga, Y., Takahara, M., Kawasaki, D., Yamauchi, Y., Suzuki, K., Hirano, K., Ryoji, K., Kamoi, 
D., Tazaki, J., Higashitani, M., Shintani, Y., Yamaoka, T., Okazaki, S., Suematsu, N., Tsuchiya, T., 
Miyashita, Y., Shinozaki, N., Takahashi, H., & Uematsu, M. (2013). Efficacy of the S.M.A.R.T. Control 
vs. other stents for aortoiliac occlusive disease in contemporary clinical practice. J Endovasc Ther, 
20, 431-43966

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 72 of 83 
FINAL  
 
67. Ponec, D., Jaff, M. R., Swischuk, J., Feiring, A., Laird, J., Mehra, M., Popma, J. J., Donohoe, D., 
Firth, B., Keim, E., & Snead, D. (2004). The nitinol S.M.A.R.T. stent vs Wallstent for suboptimal iliac 
artery angioplasty: CRISP-US trial results. J Vasc Radiol, 15, 911-918
68. Shintani, Y., Soga, Y., Takahara, M., Iida, O., Kawasaki, D., Yamauchi, Y., . . . Kawasaki, T. (2015). 
Clinical Outcomes of S.M.A.R.T. Versus Luminexx Nitinol Stent Implantation for Aortoiliac Artery 
Disease: A Propensity Score-Matched Multicenter Study. Angiology, 66(9), 875-881. 
Doi:10.1177/0003319714564207.
69. Sevil, F.C. and M. Tort, Management of endovascular treatment in spontaneous iliac artery 
dissections: Applications enabling classical surgery. Turk Gogus Kalp Damar Cerrahisi Derg, 2020. 
28(4): p. 601-608.
70. Clair, D. G., Adams, J., Reen, B., Feldman, R., Starr, J., Diaz-Cartelle, J., & Dawkins, K. D. (2014). 
The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION 
clinical trial. J Endovasc Ther, 21(2), 213-222. doi:10.1583/13-4560.1.
71. Iida, O., Soga, Y., Takahara, M., Kawasaki, D., Yamauchi, Y., Suzuki, K., Hirano, K., Ryoji, K., Kamoi, 
D., Tazaki, J., Higashitani, M., Shintani, Y., Yamaoka, T., Okazaki, S., Suematsu, N., Tsuchiya, T., 
Miyashita, Y., Shinozaki, N., Takahashi, H., & Uematsu, M. (2013). Efficacy of the S.M.A.R.T. Control 
vs. other stents for aortoiliac occlusive disease in contemporary clinical practice. J Endovasc Ther, 
20, 431-439
72. Krol, K. L., Saxon, R. R., Farhat, N., Botti, C. F., Brown, O. W., Zemel, G., . . . Katzen, B. T. (2008). 
Clinical evaluation of the Zilver vascular stent for symptomatic iliac artery disease. J Vasc Interv 
Radiol, 19(1), 15-22. doi:10.1016/j.jvir.2007.08.031.
73. O'Sullivan, G. J., Sheehan, J., Lohan, D., & McCann-Brown, J. A. (2013). Iliofemoral venous stenting 
extending into the femoral region: initial clinical experience with the purpose-designed Zilver Vena 
stent. J Cardiovasc Surg (Torino), 54(2), 255-261.
74. Ponec, D., Jaff, M. R., Swischuk, J., Feiring, A., Laird, J., Mehra, M., Popma, J. J., Donohoe, D., 
Firth, B., Keim, E., & Snead, D. (2004). The nitinol S.M.A.R.T. stent vs Wallstent for suboptimal iliac 
artery angioplasty: CRISP-US trial results. J Vasc Radiol, 15, 911-918
75. Shintani, Y., Soga, Y., Takahara, M., Iida, O., Kawasaki, D., Yamauchi, Y., . . . Kawasaki, T. (2015). 
Clinical Outcomes of S.M.A.R.T. Versus Luminexx Nitinol Stent Implantation for Aortoiliac Artery 
Disease: A Propensity Score-Matched Multicenter Study. Angiology, 66(9), 875-881. 
doi:10.1177/0003319714564207.
76. Stockx, L., Poncyljusz, W., Krzanowski, M., Schroe, H., Allocco, D. J., Dawkins, K. D., & 
Investigators, M. (2010). Express LD vascular stent in the treatment of iliac artery lesions: 24-month 
results from the MELODIE trial. J Endovasc Ther, 17(5), 633-641. doi:10.1583/09-2917MR.1.
77. Ando T., e. a. (2016). Percutaneous Versus Surgical Cut-Down Access in Transfemoral 
Transcatheter Aortic Valve Replacement: a Meta-Analysis. Journal of Cardiac Surgery, 31(12), 710-
717.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 73 of 83 
FINAL  
 
78. Caputo R., e. a. (2011). Transradial Arterial Access for Coronary and Peripheral Procedures: 
Executive Summary by the Transradial Committee of the SCAI. Catheterization and Cardiovascular 
Interventions, 78(6), 823-839.
79. Hung ML, Lee EW, McWilliams JP, et al. A reality check in transradial access: a single-centre 
comparison of transradial and transfemoral access for abdominal and peripheral intervention. Eur 
Radiol. 2019 Jan;29(1):68-74.
80. Angioplasty.org. Transradial Angioplasty. Transradial Angioplasty.
http://www.ptca.org/radial/overview.html. Accessed on 21 October 2021.
81. Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn 
1989; 16:3 7.
82. Mitchell MD, Hong JA, Lee BY, et al. Systematic review and cost benefit analysis of radial artery 
access for coronary angiography and intervention. Circulation 2012; 5:454 62.
83. Mann JT, Cubeddu MG, Schneider JE, et al. Right radial access for ptca: a prospective study 
demonstrates reduced complications and hospital charges. J Invasive Cardiol 1996; 8:40 4.
84. Brueck M, Bandorski D, Kramer W, et al. A randomized comparison of transradial versus 
transfemoral approach for coronary angiography and angioplasty. JACC Cardiovasc Interv 2009;2: 
1047 54.
85. Caputo RP, Tremmel JA, Rao S, et al. Transradial arterial access for coronary and peripheral 
procedures: executive summary by the Transradial Committee of the SCAI. Catheter Cardiovasc 
Interv 2011; 78:823 39.
86. Wang YB, Fu XH, Wang XC, et al. Randomized comparison of radial versus femoral approach for 
patients with STEMI undergoing early PCI following intravenous thrombolysis. J Invasive Cardiol 
2012; 24:412 6.
87. Mamas MA, Tosh J, Hulme W, et al. Health economic analysis of access site practice in England 
during changes in practice: insights from the British Cardiovascular Interventional Society. Circ 
Cardiovasc Qual Outcomes 2018;11: e004482.
88. Valgimigli M, Gagnor A, Calabró P, et al. Radial versus femoral access in patients with acute 
coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet 
2015;385: 2465 76.
89. Kolkailah AA, Alreshq RS, Muhammed AM, et al. Transradial versus transfemoral approach for 
diagnostic coronary angiography and percutaneous coronary intervention in people with coronary 
artery disease. Cochrane Database Syst Rev 2018;4:CD012318.
90. Chase AJ, Fretz EB, Warburton WP, et al. Association of the arterial access site at angioplasty with 
transfusion and mortality: the M.O.R.T.A.L study (Mortality benefit Of Reduced Transfusion after 
percutaneous coronary intervention via the Arm or Leg). Heart 2008; 94:1019 25.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 74 of 83 
FINAL  
 
91. Jolly SS, Yusuf S, Cairns J, et al. Radial versus femoral access for coronary angiography and 
intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, 
multicentre trial. Lancet 2011; 377:1409 20.
92. Kok MM, Weernink MGM, von Birgelen C, et al. Patient preference for radial versus femoral vascular 
access for elective coronary procedures: The PREVAS study. Catheter Cardiovasc Interv 2018; 
91:17 24.
93. Hess CN, Peterson ED, Neely ML, et al. The learning curve for transradial percutaneous coronary 
intervention among operators in the United States: a study from the National Cardiovascular Data 
Registry. Circulation 2014; 129:2277 86.
94. Cortese, B. e. (2014). Safety and Feasibility of Iliac Endovascular Interventions with a Radial 
Approach. International Journal of Cardiology, 175, 280-284.
 
 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 75 of 83 
FINAL  
 
Appendix A. Definitions
Adverse Event (AE): An Adverse Event (AE) is any untoward medical occurrence, unintended disease or 
injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other 
persons, in the context of a clinical investigation, whether or not related to the investigational device.
Allergic reaction: The hypersensitive response of the immune system of an allergic individual to a 
substance.
Angiography: A procedure performed to view blood vessels after injecting them with a radiopaque dye 
that outlines them on x-ray. This technique can be usefully used to look at arteries in many areas of the 
body, including the brain, neck (carotids), heart, aorta, chest, pulmonary circuit, kidneys, gastrointestinal 
tract, and limbs.
Arteriosclerosis: Hardening and thickening of the walls of the arteries. Arteriosclerosis can occur 
because of fatty deposits on the inner lining of arteries (atherosclerosis), calcification of the wall of the 
arteries, or thickening of the muscular wall of the arteries from chronically elevated blood pressure 
(hypertension).
Artery: A vessel that carries blood high in oxygen content away from the heart to the farthest reaches of 
the body. Since blood in arteries is usually full of oxygen, the hemoglobin in the red blood cells is 
oxygenated. 
Asymptomatic: Without symptoms. For example, an asymptomatic infection is an infection with no 
symptoms.
Blood clot: Blood that has been converted from a liquid to a solid state. Also called a thrombus.
Blood pressure: The pressure of the blood within the arteries. It is produced primarily by the contraction 
of the heart muscle. Its measurement is recorded by two numbers. The first (systolic pressure) is 
measured after the heart contracts and is highest. The second (diastolic pressure) is measured before the 
heart contracts and lowest.
Complication: In medicine, an additional problem that arises following a procedure, treatment or illness 
and is secondary to it. 
Device related complication - complication attributed to the device (e.g. graft migration, graft infection, 
etc.).
Procedure-related complications - complication not attributed to device but arises following the 
procedure (e.g., cardiac issue, renal insufficiency, etc.).
Computerized tomography scan (CT scan): Pictures of structures within the body created by a 
computer that takes the data from multiple X-ray images and turns them into pictures on a screen. CT 
stands for computerized tomography.
Death: All-cause mortality.
Delivery System Failure: Delivery system did not perform as intended during the stent placement 
procedure.
Device deficiency: Inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety or performance.  Includes malfunctions, use errors, and inadequate labelling.
Device malfunction: The failure of a device to meet any of its performance specifications or otherwise 
perform as intended.  Performance specifications include all claims made in the IFU/IB.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 76 of 83 
FINAL  
 
Dilation: The process of enlargement, stretching, or expansion. The word "dilatation" means the same 
thing. Both come from the Latin "dilatare" meaning "to enlarge or expand."
Dissection:
0
None
A
Small radiolucent area within lumen of the vessel
B
Linear, non-persistent extravasation of contrast
C
Extraluminal, persisting extravasation of contrast
D
Spiral shaped filling defect
E
Persistent lumen defect with delayed anterograde flow
F
Filling defect accompanied by total occlusion
Duplex ultrasound Success: The presence of a triphasic waveform, or biphasic doppler waveform 
in a patient whose post-procedural CFA doppler waveform was biphasic.  The duplex ultrasound 
scan must be taken at a 60o angle to the direction of the blood flow.
Duplex ultrasound Failure: The presence of a monophasic waveform, or a biphasic doppler 
waveform in a patient whose post procedural common femoral artery doppler waveform was 
triphasic.  The duplex ultrasound scan must be taken at a 60o angle to the direction of the blood flow.
Embolization: A treatment that clogs small blood vessels and blocks the flow of blood.
Hematoma: A mass of usually clotted blood that forms in a tissue, organ, or body space as a result of a 
broken blood vessel.
Hemostasis: Absence of any signs of arterial pulsatile bleeding or signs of expanding or developing 
hematoma.
High blood pressure: Also known as hypertension, high blood pressure is, by definition, a repeatedly 
elevated blood pressure exceeding 140 over 90 mmHg 
Immunodeficiency: Inability to mount a normal immune response. Immunodeficiency can be due to a 
genetic disease or acquired as in AIDS due to HIV.
Inflammation: A basic way in which the body reacts to infection, irritation or other injury, the key feature 
being redness, warmth, swelling and pain. Inflammation is now recognized as a type of nonspecific 
immune response. 
Low blood pressure: Any blood pressure that is below the normal expected for an individual in a given 
environment. Low blood pressure is also referred to as hypotension.
Magnetic Resonance Angiogram (MRA): A noninvasive test that has demonstrated usefulness in 
defining the anatomy of blood vessels of certain size in the head and neck. MRA serves as a complement 
to traditional MRI scanning in evaluation of the brain and neck. 
Magnetic Resonance Imaging (MRI): A special radiology technique designed to image internal
structures of the body using magnetism, radio waves, and a computer to produce the images of body 
structures. For more information, see: Magnetic Resonance Imaging; Paul C. Lauterbur; Peter Mansfield.
Major Adverse Event (MAE):  For this study, an MAE is any AE/SAE which resulted in one or more of
the following: death, index limb amputation or target lesion revascularization.
Myocardial infarction: Q-wave MI with CK/MB fraction > 3 times the upper limit of normal.
Occlusion: A complete absence of flow within a blood vessel.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 77 of 83 
FINAL  
 
Operation: Although there are many meanings to the word "operation", in medicine it refers to a surgical 
procedure.
Peripheral: Situated away from the center, as opposed to centrally located.
Procedural Success: Absence of device malfunctions during the index procedure.
Pseudoaneurysm: An encapsulated hematoma in communication with an artery.
Rupture: A break or tear in any organ or soft tissue 
Rutherford/Becker Classification: 
Grade
Category
Clinical Description
Objective Criteria
0
0
Asymptomatic, no hemodynamic 
significant occlusive disease
Normal results of treadmill test (five 
minutes at 2 mph on 12 incline. 
I
1
Mild claudication
Treadmill exercise completed, post-
exercise AP is greater than 50 mm Hg 
but more than 25 mm Hg less than 
normal
2
Moderate claudication
Symptoms between those of categories 
1 and 3
3
Severe claudication
Treadmill exercise cannot be completed, 
post-exercise AP is <50 mm Hg
II
4
Ischemic rest pain
Resting AP of <40 mm Hg, flat or barely 
pulsatile ankle or metatarsal 
plethysmographic tracing; toe pressure 
<30 mmHg
I I
5
Minor tissue loss - non-healing 
ulcer, 
focal 
gangrene 
with 
diffuse pedal ischemia
Resting AP <60 mm Hg, ankle or 
metatarsal plethysmographic tracing flat or 
barely pulsatile; toe pressure less than 40 
mm Hg  
6
Major tissue loss - extending 
above transmetatarsal
level, 
functional 
foot 
no 
longer 
salvageable
Same as for category 5
Scan: The data or image obtained from the examination of organs or regions of the body by gathering 
information with a sensing device.
Serious Adverse Event (SAE): Any AE that led to any of the following:
a)
death
b)
serious deterioration in the health of the subject, that resulted in any of the following:
life-threatening illness or injury;

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 78 of 83 
FINAL  
 
permanent impairment of a body structure or a body function;
hospitalization or prolongation of existing hospitalization;
medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function; 
chronic disease
c)  
fetal distress, fetal death or a congenital physical or mental impairment or birth defect
Stent: A tube designed to be inserted into a vessel or passageway to keep it open.
Stent Thrombosis: Formation of thrombus within the AAA stent graft (aortic bifurcate or one or both iliac 
limbs) leading to significant limitation of blood flow, requiring secondary intervention to restore blood flow 
Surgery: The branch of medicine concerned with diseases and conditions which require or are amenable 
to operative procedures. Surgery is the work done by a surgeon. 
Stroke: Any acute, new, persistent, documented neurological deficit ending in death or lasting greater 
than 24 hours and classified by a physician as a stroke.
Symptom: Any subjective evidence of disease. 
Target lesion: The site of stenosis/restenosis.
Target lesion revascularization: Revascularization of the target lesion using either bypass surgery 
or percutaneous (i.e., angioplasty) techniques.
Technical Success:
through the vasculature, successful deployment of the study device (S.M.A.R.T.TM stent) at the 
intended location, and successful withdrawal of the delivery system without conversion to femoral 
access.
Thrombosis
Formation of thrombus within a blood vessel leading to significant limitation of blood flow, 
requiring secondary intervention to restore blood flow (e.g., thrombolysis, thrombectomy, PTA)
Thrombus: Discrete, mobile intraluminal filling defect with defined borders with or without associated 
contrast staining.
Ultrasound: High-frequency sound waves used to bounce off of tissues using special devices. The 
echoes are then converted into a picture called a sonogram. 
Unanticipated Serious Adverse Device Effect (USADE): A serious adverse effect related to the use of 
a study device which by its nature, incidence, severity or outcome has not been identified in the current 
risk assessment or any other unanticipated serious problem associated with a study device that relates to 
the rights, safety, or welfare of subjects.
Vessel: A tube in the body that carries fluids: blood vessels or lymph vessels.

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 79 of 83 
FINAL  
 
Appendix B. Acronyms and Abbreviations
Acronym / 
Abbreviation
Term
ACM
AE
AP
BID
BP
CEC 
CFA
CFR
CI
Cm
COV
CRF
CRO 
CSR
CT
DSMB 
ECeCRF 
EDC
EQ-5D
EU
FDA
Fr
GCP 
GDPR
GFR
IB
ICF
ICH
IFU 
IMV
ISO
ITT 
MAE 
mm
mmHg
mSv
NCA
PPA
PTA 
PAD
QD 
RVD
SAE
SF-36
SFA
SOP
TFA
TFATIA
All-cause mortality
Adverse Event
Anterior/Posterior
Twice Daily
Blood Pressure
Clinical Events Committee
Common Femoral Artery
Code of Federal Regulations
Confidence Interval
Centimeter
Closeout Visit
Case Report Form
Contract Research Organization
Clinical Study Report
Computerized Axial Tomography Scan
Data and Safety Monitoring Board
Ethics Committee Electronic Case Report Form
Electronic Data Capture
EuroQOL-5 Dimension
European Union
Food and Drug Administration
French (sizing unit for devices)
Good Clinical Practice
General Data Protection Regulation
Glomerular Filtration Rate
Investigator Brochure
Informed Consent Form
International Council on Harmonization
Instructions for Use
Interim Monitoring Visits
International Organization for Standardization
Intent-to-treat
Major Adverse Event
Millimeter 
Millimeters of mercury (unit of pressure)
Millisievert
National Competent Authorities
Proximal popliteal artery
Percutaneous transluminal angioplasty
Peripheral Arterial Disease
Once Daily
Reference Vessel Diameter
Serious adverse event
Short-Form 36
Superficial femoral artery
Standard Operating Procedures
Transfemoral Artery
Transfemoral Arterial

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 80 of 83 
FINAL  
 
Acronym / 
Abbreviation
Term
TIA
TLR
TRA
USADE 
Transient Ischemic Attack
Target lesion(s) revascularization
Transradial Arterial
Unanticipated Serious Adverse Device Effect

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 81 of 83 
FINAL  
 
Appendix C. Participating Investigators and Sites
Site Investigator Name
Site Name
Site Address
Site Country
Dr. Koen Deloose
ID3 Medical CVBA
(A.Z. Sint-Blasius Hospital-
Dendermonde)
Kroonveldlaan 50
9200 Dendermonde
Belgium
Prof. Andrea Kahlberg
IRCCS San Raffaele 
Scientific Institute
Via Olgettina 60 20132 Milan
Italy
Dr. Luca Bertoglio
University of Brescia/ASST 
Spedali Civili Hospital
Piazzale Spedali Civili 1, 
25123 Brescia
Italy
Dr. Paolo Sbarzaglia
Maria Cecilia Hospital Via 
Corriera
1 Cotignola
Ravenna 48033
Italy
Dr. Giovanni Balestriero
Belluno General Hospital
Viale Europa 22, 32100
Belluno BL
Italy
Prof. Marianne 
Brodmann
Medical University Graz
Auenbruggerplatz 27, Graz
Austria
Dr. Martin Werner
Hanusch Krankenhaus
Henirich Collin Strasse 30
1140 Vienna
Austria
Prof. Dr. Klaus A. 
Hausegger
KABEG  Klinikum Klagenfurt 
am Wörthersee
Dept. of Diagnostic and 
Interventional Radiaology
Feschnigstraße 11
Klagenfurt Kärnten 9020
Austria
Prof. Oliver Schlager
Medical University of Vienna
Spitalgasse 23, 1090, Vienna 
Austria
Dr. Christoph Binkert
Kantonsspital Winterthur
Brauerstrasse 15
Winterthur 840
Switzerland
Prof. Raphael Coscas
CHU Ambroise Paré
CHU Ambroise Paré
AP-HP 9 Ave Charles de 
Gaulle
Boulogne-Billancourt 92100
France
Dr. Antoine Sauguet
Pasteur Clinic
SCP des Médecins 
Cardiologues
45 Ave de
Lombrez BP
France
Prof. Yann Gouëffic
Groupe Hôpital Paris St 
Joseph
Vascular and Endovascular 
Surgical Center
185 rue Raymond Losserand
Paris 75014
France

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 82 of 83 
FINAL  
 
Site Investigator Name
Site Name
Site Address
Site Country
Dr. Gilles Goyault
Cardiovascular Institute 
Strasbourg - Clinque Rhena
10 rue Francois Epailly, 
Strasbourg, 67000 Alsace
France
Dr. Gerd Groezinger
University Hospital Tubingen
Hoppe-Seyler-Straße 3
72076 Tübingen
Germany
Dr. Arne Schwindt
St. Franziskus Hospital 
Muenster
Hohenzollernring 70
Munster NRW, 48145
Germany
Dr. Mercedes Guerra
University Hospital of 
Guadalajara
Donante de sangre s/n
19002 Guadalajara
Secretaría del Servicio de 
Angiología,Cirugía Vascular y 
Endovascular
Spain
 
 
 
 
 
 
 
 
 
 
 
 

RADIANCY / P21-7701                                                  
 
 
  
                               
Version: 7.0 / March 21, 2023
               
CONFIDENTIAL 
Page 83 of 83 
FINAL  
 
Appendix D. EASY Hematoma Classification System
 
The table below should be used to classify hematomas94: 
Grade
I
II
III
IV
V
Incidence
<3%
<2%
<0.01%
Definition
Local hematoma, 
superficial
Hematoma with 
moderate muscular 
infiltration
Forearm Hematoma 
and muscular 
infiltration, below the 
elbow
Hematoma and 
muscular infiltration 
extending above the 
elbow
Ischemic threat 
(compartment 
syndrome)
Treatment
Analgesia
Additional bracelet
Local ice
Analgesia
Additional bracelet
Local ice
Analgesia
Additional bracelet
Local ice
Inflated BP cuff
Analgesia
Additional bracelet
Local ice
Inflated BP cuff
Consider surgery
Notes
Inform physician
Inform physician
Inform physician
Stat call to 
physician
Remarks
- Control blood pressure (BP) (importance of pain management)
- Consider interruption of any anticoagulation and/or antiplatelet infusion
- Follow forearm and arm diameters to evaluate requirement for additional bracelet and/or BP cuff inflation
- Additional bracelet(s) can be placed alongside artery anatomy
- Ice cubes in a plastic bag or washcloth are placed on the hematoma
- Finger O2 saturation can be monitored during inflated blood pressure cuff
- To inflate blood pressure cuff, select a pressure of 20 mmHg < systolic pressure and deflate every 15 minutes
- After bracelet removal, use "Velpeau bandage" around forearm/arm for a few hours to maintain mild positive 
pressure