Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter) for Conformité Européene (CE) Mark Approval
Conditions: PAD
Sponsor: W.L.Gore & Associates

 
GORE® Drug-Coated PTA Balloon Catheter 
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Nothing herein is to be disclosed in any way without the prior 
express written permission of W. L. Gore & Associates, Inc. 
 
 
 
 
 
 
 
 
 
Clinical Investigation of the GOREP®
P Drug-Coated PTA Balloon Catheter (GOREP® 
PDCB Catheter) 
for CE Mark Approval 
 
 
 
Protocol Number: DCB 15-02 
               14Feb2017 
 
 
 
 
 
W. L. Gore & Associates, Inc. 
Medical Products Division 
 
 

 
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PROTOCOL MODIFICATION SUMMARY 
 
List of Changes in: Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® 
DCB Catheter) for CE Mark Approval Revision 2 (DCB 15-02) 
 
The following administrative changes have been made to the protocol: 
• 
Minor typographical and punctuation errors have been corrected in Section 9.1.2.  
• 
In addition, the following changes have been made to the protocol: 
 
 
Changes incorporated during September 2016 BfArM and Ethics Committee submission cycle: 
0BSection 
Changes to Protocol 
Rationale 
Section 9.1.2 – 
Adverse Event 
Classification, Serious 
Adverse Event 
Added Note 3, to include the 
German Serious Adverse 
Event definition according to 
§2 No. 5 MPSV. 
Required addition for BfArM 
approval 
 
Modifications made in Sept 
2016 during first cycle of 
BfArM responses 
Section 9.1.4 – 
Serious AE reporting  
Added the last paragraph to 
include the quarterly 
summary evaluation of all 
SAEs per BfArM’s new 
process. 
Required addition for BfArM 
approval 
 
Modifications made in Sept 
2016 during first cycle of 
BfArM responses 
 
Changes incorporated during February 2017 BfArM and Ethics Committee submission cycle to  
include ISO 14155:2011 compliance items: 
1BSection 
Changes to Protocol 
Rationale 
Entire document  
Added or corrected the 
register mark for GORE 
 
Consistency in referencing 
Gore’s register mark 
Title Page 
Added 10 Feb 2017 date 
after Protocol Number 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011 
compliant 
Protocol Modification 
Summary 
Added Protocol Modification 
Summary after Title Page 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011 
compliant 
 
 
 
 
 
 

 
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2BSection 
3BChanges to Protocol 
4BRationale 
Protocol Summary 
Authorized Representative 
Added 
 
Updated Primary Objective 
and added Secondary 
Objective and hypothesis 
removed 
 
Study Endpoints section: 
Primary and Secondary 
Endpoints clarified  
 
Number of Sites section: 
added reference to the 
maintenance of the 
investigator list 
 
Added Coordinating 
Investigator section 
 
Added Expected Time of 
Each Study Subject to 
Complete the Study and Total 
Expected Duration of the 
Study sections 
 
Added Early Safety 
Enrollment Section 
 
Updated Independent Review 
section with addresses for 
contractors and detail for 
CEC / DSMB  
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011 
compliant 
 
Detail added to match body of 
Protocol 
List of Abbreviations 
Added DSMB 
Omitted in earlier version by 
mistake 
Section 1.2 
Added updated information 
on TACS II guideline 
 
Table 3 updated with new 
information 
New information became 
available 
Section 1.3 
Updated indication and 
manufacturer 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011 
compliant 

 
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5BSection 
6BChanges to Protocol 
7BRationale 
Sections 1.4 and 1.5 
Sections added 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011 
compliant 
Sections 2.1 and 2.2 
Updated Primary Objective 
and added Secondary 
Objective 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011 
compliant 
Section 3.1 
Added information about 
comparator and OPC 
 
Provided statement that 
Sponsor would maintain an 
updated investigator list 
 
Added safety review after 10 
subjects enrolled 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011 
compliant 
 
Modifications made in Feb 
2017 at request of BfArM 
Reviewer  
Section 3.2.2 
Split  primary endpoints info 
performance and safety 
endpoints 
Details added in Feb 2017 for 
clarity 
Section 4.1 
Provided clarification to 
patient population and 
subject population and 
rationale for treatment 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011 
compliant 
Section 4.2 
Added new inclusion #6 -
Patient is not a candidate for 
conservative therapy or has 
undergone conservative 
therapy that was not 
successful. 
 
Changed original #6 to #7 
Modification made in Feb 2017 
at the request of BfArM 
reviewer 
Section 4.3 
Exc #9: Added abbreviation 
for POBA 
 
Exc #18: Changed 72 hours 
to 30 days 
 
Exc #27: Changed to Patients 
with active vasculitis 
 
Added new Exc #28 – 
Patients with active tumor 
disease related to cancer 
 
Added in Feb 2017 for 
clarification 
 
Modifications made in Feb 
2017 at request of BfArM 
reviewer 

 
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Changed original Exc #’s 28 
& 29, to #’s 29 & 30 
respectively 
Section 5 
Added information including 
factors that may compromise 
the outcome of the study   
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011 
compliant 
Section 5.1 
Updated figure 2 to reflect 10 
patient safety cohort 
Modification made in Feb 2017 
at request of BfArM Reviewer 
Section 5.2  
Table 4 modified to include 
14 day follow up for 10 
subject safety follow up and 
added pharmacokinetic 
testing for plasma paclitaxel 
levels for these same 10 
subjects  
Modifications made in Feb 
2017 at request of BfArM 
Reviewer 
Section 5.4 
Added new baseline 
evaluations collected after 
informed consent: 
pharmacokinetic testing for 
plasma paclitaxel level for 
first 10 subjects only 
 
Modifications made in Feb 
2017 at request of BfArM 
Reviewer 
Section 5.6  
Added a statement about the 
reason for pre-dilation prior to 
use of the Gore device 
indicating that the Gore 
device is the second dilation 
Modifications made in Jan 
2017 during first cycle of 
Freiburg Ethics Committee 
responses 
Section 5.6  
Clarified standard of care 
treatments 
 
Added Post-procedure 
evaluation: Pharmacokinetic 
testing for plasma paclitaxel 
level – immediately after 
procedure, 1 hour post 
procedure, and 3 hours post 
procedure for first 10 subjects 
only 
 
Added Discharge evaluation: 
Pharmacokinetic testing for 
plasma paclitaxel level – at 
24 hours or at discharge 
whichever is sooner for the 
first 10 subjects only 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011 
compliant 
 
Modifications made in Feb 
2017 at request of BfArM 
Reviewer 

 
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8BSection 
9BChanges to Protocol 
10BRationale 
Section 5.8 
Added 14 day follow up 
information 
Modifications made in Feb 
2017 at request of BfArM 
Reviewer 
Section 6.2 
Monitoring, provided more 
clarity and included a 
minimum number of visit 
Modifications made in Jan 
2017 during first cycle of 
Freiburg Ethics Committee 
responses 
Section 6.7 
Presence of Sponsor, 
clarified that it was for 
observation of the procedure 
under the PI supervision 
Modifications made in Jan 
2017 during first cycle of 
Freiburg Ethics Committee 
responses 
Section 6.3 
Updated device information 
to reflect rationale for number 
of devices used and 
collection of data regarding 
devices 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011 
compliant 
Section 6.9 
Updated period of time to 
maintain records for BfS 
Modifications made in Feb 
2017as result of new 
information 
Section 6.10 
Publication Plan, provided 
more detail about the 
publication committee and 
timing of potential 
publications 
Modifications made in Jan 
2017 during first cycle of 
Freiburg Ethics Committee 
responses 
Section 7 
Added information regarding 
the Clinical Data 
Management Plan 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011  
Compliant 
Section 7.1 
Inserted additional review by 
Quality Assurance 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011  
Compliant 
Section 7.2 
Added statement about 
periodic data review 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011  
Compliant 
Section 8.1 
Added competitive device 
reference to AEs and rates 
and other known risk 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011  
Compliant 
 
 
 

 
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1BSection 
12BChanges to Protocol 
13BRationale 
Section 8.2 
Added statements on 
sponsor’s risk management 
activities 
 
Added bullet related to 
concomitant medical 
treatments 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011  
Compliant 
Section 8.2.1 
Section added to cover early 
safety monitoring process 
Modifications made in Feb 
2017 at request of BfArM 
Reviewer 
Section 8.4 
Risk to Benefit Rationale, 
corrected last statement 
 
Added additional information 
regarding risk management 
activities  
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011  
Compliant  
 
Correcting prior error 
Section 9.1.1 
Added definition of Adverse 
Device Effect 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011  
Compliant 
Section 9.1.2 
Added definition of Serious 
Adverse Device Effect 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011  
Compliant 
Section 9.3 
CEC/DSMB, provided more 
detail and termination 
language 
Modifications made in Jan 
2017 during first cycle of 
Freiburg Ethics Committee 
responses 
Section 10.1 
Moved hypothesis from 
summary to Statistical 
Analysis section 
Modified in Feb 2017 for 
clarification 
Section 10.4.4 
Provided information 
regarding both the 
performance endpoint and 
safety endpoint  
Modified in Feb 2017 for 
clarification 
Section 10.4.6 
Added sub-group analysis 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011  
Compliant 
Section 11.2 
Clarified additional 
requirements relative to 
compliance responsibilities  
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011  
Compliant 

 
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Section 11.3 
Removed reference to legal 
authorized representative and 
added emergency contact 
detail 
Modifications made in Feb 
2017 at the request of BfArM 
to be ISO 14155:2011  
Compliant 
Section 11.8 
Included termination criteria 
per ISO 14155:2011 and 
actions to be taken at 
termination 
Modifications made in Jan 
2017 during first cycle of 
Freiburg Ethics Committee 
responses 
Section 12 
Added reference 30 
Modified in Feb 2017 to 
identify new reference 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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34TPROTOCOL SUMMARY 
Study Title 
Clinical Investigation of the GOREP®
P Drug-Coated PTA 
Balloon Catheter (GOREP® 
PDCB Catheter) for CE Mark 
Approval 
Protocol Number 
DCB 15-02   
Sponsor 
W. L. Gore & Associates, Inc. 
Medical Products Division 
1505 North Fourth Street 
Flagstaff, Arizona 86004  U.S.A. 
Authorized 
Representative 
Graeme Shepherd 
W. L. Gore & Associates (UK) Ltd 
Mariner Drive • Dundee Technology Park 
Dundee, DD2 1 JA 
SCOTLAND 
Study Design 
Prospective, multi-center, single-arm study characterizing 
outcomes in subjects with Peripheral Artery Disease (PAD) 
lesions treated with percutaneous transluminal angioplasty 
(PTA) using the GOREP®
P DCB Catheter. 
Study Objective 
The primary objectives of the clinical investigation are to 
evaluate the performance and the safety of the GOREP®
P DCB 
Catheter in the treatment of de novo and restenotic 
atherosclerotic lesions in the superficial femoral and 
popliteal arteries (SFA/PA) of patients with symptomatic 
PAD. 
The secondary objectives of the clinical investigation are to 
assess procedural success and the long term performance 
and safety of the GOREP®
P DCB Catheter. 
 
Study Endpoints 
UPrimary Endpoints 
 
The primary performance endpoint: six month late lumen 
loss (LLL) defined as the difference in minimum lumen 
diameter of the Target lesion between the time points 
immediately post-intervention and the 6-month follow-up 
angiography or at the time of a Clinically Driven Target 
Lesion Revascularization (CD TLR), whichever is earlier. 
 
The primary safety endpoint: A composite 30-day safety 
endpoint is freedom from Major Adverse Events (MAE), 
defined as i) death, ii) Clinically-Driven Target Vessel 
Revascularization (CD TVR), or iii) amputation above the 
metatarsals, resulting from a vascular event, in the 
treated leg (Target limb amputation). 
 

 
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Secondary Endpoints at Procedure 
 
Acute Device Success 
 
Acute Procedural Success 
 
Technical Success 
 
Treated region thrombosis 
 
% of subjects that require Provisional Stenting 
 
Secondary Endpoints for all follow-up assessments: 
 
Primary patency (freedom from clinically-driven TLR and 
freedom from restenosis as determined by duplex 
ultrasound (DUS) peak systolic velocity ratio (PSVR) ≤ 
2.4 or angiographic stenosis < 50%) 
 
Freedom from MAE 
 
Freedom from TVR 
 
Freedom from CD-TVR 
 
Freedom from TLR 
 
Freedom from CD-TLR 
 
Rutherford improvement 
 
Ankle-Brachial Index (ABI) improvement 
 
Quality of life change 
 
Assisted primary patency 
 
Secondary patency 
Subject Population 
Patients with de novo or restenotic superficial 
femoral/popliteal artery lesions; stenosis ≥70%; lesion length 
30 - 150 mm; reference vessel diameter 4 - 6 mm; 
Rutherford 2 - 4. 
Number of Subjects 
52 subjects 
Number of Sites 
Up to 10 study sites in Germany 
 
The Sponsor shall maintain an updated list of principal 
investigators, investigation sites, and institutions. This list 
shall be kept separately from this Protocol. 
Coordinating 
Investigator 
Prof. Dr. med Thomas Zeller 
Universitäts-Herzzentrum Bad Krozingen 
Südring 15 
79189 Bad Krozingen, Germany 
Expected Time to 
Complete Enrollment  
35T~ 6 months 
Expected Time of each 
Study Subject to 
Complete the Study 
35T~24 months 
Total Expected Duration 
of the Study 
35T~ 30 months 
Significant 
Inclusion/Exclusion 
Criteria 
35TSignificant Inclusion Criteria: 
 
35TPAD patients with Rutherford Class 2 - 4 

 
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 
35TDe novo or restenotic lesions, including total occlusions 
of the SFA/PA 
 
35T1 lesion which may include one or more regions of 
luminal narrowing ≥70% with a total combined lesion 
length between 30 - 150mm and a reference vessel 
diameter of 4 – 6mm 
 
35T1 patent tibial or peroneal artery 
 
35TSignificant Exclusion Criteria: 
 
35TSurgical or endovascular access in the Target 
limb/vessel within the previous 30 days 
 
35TPrior treatment of the Target lesion with PTA within 90 
days or any prior treatment with drug-coated balloon 
 
35TPrior treatment of the Target vessel with stenting or 
bypass 
 
35TIliac artery inflow lesions that cannot be successfully 
treated during the Index procedure 
 
35TAcute or subacute thrombus or arterial aneurysm in 
Target limb 
 
35TSevere calcification that renders the Target lesion non-
dilatable 
 
35TAcute or chronic renal dysfunction (serum creatinine 
≥2.5 mg/dL) 
Schedule of Events: 
 
Baseline Screening  
Assessments 
• Demographics 
• Medical History (including height and weight) 
• Blood Work – RBC, WBC, Platelets, Creatinine  
• Rutherford Classification 
• ABI 
• Lesion Characteristics (by angiography at time of 
intervention) 
• Quality of Life Questionnaires (EQ-5D, PAQ) 
• Antiplatelet and Anticoagulant therapy 
Study  
Procedure 
• Angiography 
• Balloon Inflation 
• Provisional Stenting 
• Adverse Events 
Early Safety Enrollment • The first 10 subjects will be enrolled at a single institution 
by the Coordinating Investigator. Pharmacokinetic 
testing for plasma paclitaxel levels will be collected. 
Safety data will be reviewed prior to continuing study 
enrollment at all sites.  
Follow-up  
Assessments 
1-, 6-, 12-, and 24-month follow-up evaluations: 
• 
Medications – antiplatelet and anticoagulants only 
• 
Adverse Events 
• 
Rutherford Classification 

 
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• 
ABI 
• 
Quality of Life Questionnaires (EQ-5D, PAQ) 
• 
CDUS 
 
6- month follow-up evaluation: 
Angiography of Target limb 
Independent Review 
Ultrasound, Angiography Core Labs:  
coreLab Black Forest GmbH 
Südring 15 
79189 Bad Krozingen, Germany 
 
Clinical Research Monitoring:  
InnoRa GmbH 
Robert-Koch-Platz 4 
10115 Berlin, Germany 
 
Combined Clinical Events Committee (CEC) and Data 
Safety Monitoring Board (DSMB):  
 
35TIndependent of Sponsor, coordinated by non-
Sponsor Administrator 
 
35TMembers shall not be participating investigators in 
the study 
 
35TSponsor will provide operational support 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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LIST OF ABBREVIATIONS 
ABI 
Ankle-Brachial Index 
AE 
Adverse Event 
BfArM 
Bundesinstitut für Arzneimittel und Medizinprodukte 
(The Federal Institute for Drugs and Medical Devices) 
BfS 
Bundesamt für Strahlenschutz 
(The Federal Office for Radiation Protection) 
CAD 
Coronary Artery Disease 
CBC 
Complete Blood Count 
CDUS 
Color Flow Duplex Ultrasound 
CDMS 
Clinical Data Management System 
CE 
Conformité Européenne 
CEC 
Clinical Events Committee 
CFA 
Common Femoral Artery 
CHF 
Congestive Heart Failure 
CIP 
Clinical Investigation Plan 
cm 
Centimeters 
COPD 
Chronic Obstructive Pulmonary Disease 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DSMB 
EC 
Data Safety Monitoring Board 
Ethics Committee 
eCRF 
Electronic Case Report Form 
ePTFE 
Expanded Polytetrafluoroethylene 
EU 
European Union 
FDA 
Food and Drug Administration (United States) 
FEP 
Fluorinated Ethylene Propylene 
Fr 
French (sizing) 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practice 
HIT 
Heparin-Induced Thrombocytopenia 
IB 
Investigators Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IFU 
Instructions for Use 
IVUS 
Intravascular UItrasound 
MAE 
Major Adverse Event 
MedDRA 
Medical Dictionary for Regulatory Activity 
MI 
Myocardial Infarction 
mm 
Millimeters 
OUS 
Outside United States 

 
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PAD 
Peripheral Artery Disease 
PG 
Performance Goal 
PHI 
Protected Health Information 
PI 
Principal Investigator 
PA 
Popliteal Artery 
PSV 
Peak Systolic Velocity 
PSVR 
Peak Systolic Velocity Ratio 
PTA 
Percutaneous Transluminal Angioplasty 
SAE 
Serious Adverse Event 
SFA 
Superficial Femoral Artery 
TIA 
Transient Ischemic Attack 
TLR 
Target Lesion Revascularization 
TVR 
Target Vessel Revascularization 
U.S. 
United States 
UADE 
Unanticipated Adverse Device Effect 
 

 
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2TPROTOCOL MODIFICATION SUMMARY 2T ............................................................................................................... ii 
2TPROTOCOL SUMMARY 2T .......................................................................................................................................... ix 
2TLIST OF ABBREVIATIONS2T ................................................................................................................................... xiii 
2T1.2T 
2TIntroduction2T ........................................................................................................................................................ 1 
2T1.1.2T 
2TDisease2T ................................................................................................................................................... 1 
2T1.2.2T 
2THistorical Treatments2T ............................................................................................................................. 2 
2T1.3.2T 
2TStudy Device Description2T ....................................................................................................................... 3 
2T1.4.2T 
2TPre-Clinical Data2T..................................................................................................................................... 4 
2T1.5.2T 
2TClinical Data2T ........................................................................................................................................... 5 
2T2.2T 
2TStudy Objectives2T ............................................................................................................................................... 5 
2T2.1.2T 
2TPrimary Objective(s)2T ............................................................................................................................... 5 
2T2.2.2T 
2TSecondary Objective(s) 2T .......................................................................................................................... 5 
2T3.2T 
2TStudy Design2T ...................................................................................................................................................... 5 
2T3.1.2T 
2TDescription of Study Design2T ................................................................................................................... 5 
2T3.2.2T 
2TStudy Endpoints2T ..................................................................................................................................... 6 
2T3.2.1.2T 
2TDefinitions2T ................................................................................................................................ 6 
2T3.2.2.2T 
2TPrimary Endpoints2T ................................................................................................................... 8 
2T3.2.3.2T 
2TSecondary Endpoints 2T .............................................................................................................. 8 
2T4.2T 
2TStudy Population2T ............................................................................................................................................... 9 
2T4.1.2T 
2TDescription of Population2T ....................................................................................................................... 9 
2T4.2.2T 
2TInclusion Criteria2T ..................................................................................................................................... 9 
2T4.3.2T 
2TExclusion Criteria2T.................................................................................................................................. 10 
2T5.2T 
2TStudy Procedures/Evaluations2T ...................................................................................................................... 11 
2T5.1.2T 
2TStudy Procedures and Evaluation Schema (Figure 2) 2T  
2T5.3.2T 
2TInformed Consent Process 2T ................................................................................................................... 14 
2T5.4.2T 
2TPre-Screening / Screening2T ................................................................................................................... 14 
2T5.5.2T 
2TEnrollment2T ............................................................................................................................................ 15 
2T5.6.2T 
2TProcedure2T ............................................................................................................................................. 16 
2T5.7.2T 
2TRepeat Interventions2T ............................................................................................................................ 19 
2T5.8.2T 
2TFollow-Up2T ............................................................................................................................................. 19 
2T5.9.2T 
2TSubject Withdrawal from the Study2T ...................................................................................................... 20 
2T5.10.2T 
2TSubject Lost to Follow-Up2T .................................................................................................................... 20 
2T5.11.2T 
2TSubject Study Completion2T .................................................................................................................... 20 
2T5.12.2T 
2TDevice Deficiencies2T .............................................................................................................................. 21 
2T6.2T 
2TStudy Administration2T ...................................................................................................................................... 21 
2T6.1.2T 
2TTraining2T ................................................................................................................................................. 21 
2T6.2.2T 
2TMonitoring2T ............................................................................................................................................. 21 
2T6.3.2T 
2TDevice Accountability, Storage and Return 2T .......................................................................................... 22 
2T6.4.2T 
2TCore Lab2T ............................................................................................................................................... 23 
2T6.5.2T 
2TProtocol Deviations2T .............................................................................................................................. 23 
2T6.6.2T 
2TProtocol Amendments2T .......................................................................................................................... 23 
2T6.7.2T 
2TPresence of Sponsor Representatives 2T ................................................................................................. 23 
2T6.8.2T 
2TAccess to Source Data/Documents2T...................................................................................................... 23 
2T6.9.2T 
2TStudy Records Retention2T ..................................................................................................................... 24 
2T6.10.2T 
2TPublication Plan2T .................................................................................................................................... 25 

 
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2T7.2T 
2TData Collection and Submission2T ................................................................................................................... 25 
2T7.1.2T 
2TData Collection Methods 2T ...................................................................................................................... 25 
2T7.2.2T 
2TData Clarification and Correction2T ......................................................................................................... 26 
2T7.3.2T 
2TCRF Completion Schedule2T ................................................................................................................... 26 
2T8.2T 
2TRisk Assessment2T ............................................................................................................................................. 26 
2T8.1.2T 
2TPotential Risks2T ...................................................................................................................................... 26 
2T8.2.2T 
2TMinimization of Risks2T ............................................................................................................................ 28 
2T8.2.1.2T 
2TEarly Safety Monitoring2T ......................................................................................................... 29 
2T8.3.2T 
2TSummary of Expected Benefits 2T ............................................................................................................ 30 
2T8.4.2T 
2TRisk-to-Benefit Rationale2T ...................................................................................................................... 30 
2T9.2T 
2TAdverse Events and Safety Monitoring 2T ........................................................................................................ 30 
2T9.1.2T 
2TAnticipated Adverse Events 2T ................................................................................................................. 31 
2T9.1.1.2T 
2TAdverse Event Relationship2T .................................................................................................. 31 
2T9.1.2.2T 
2TAdverse Event Classification2T ................................................................................................. 31 
2T9.1.3.2T 
2TAdverse Event Reporting and Coding2T ................................................................................... 32 
2T9.1.4.2T 
2TSerious AE reporting2T ............................................................................................................. 33 
2T9.1.5.2T 
2TSubject Death2T ........................................................................................................................ 34 
2T9.1.6.2T 
2TSubject Withdrawal or Discontinuation2T ................................................................................. 34 
2T9.2.2T 
2TUnanticipated Adverse Device Effects (UADE) 2T .................................................................................... 34 
2T9.3.2T 
2TClinical Events Committee/Data Safety Monitoring Board 2T ................................................................... 34 
2T10.2T 
2TStatistical Analysis2T .......................................................................................................................................... 35 
2T10.1.2T 
2TStudy Hypotheses2T ................................................................................................................................ 35 
2T10.2.2T 
2TSample Size Assumptions 2T .................................................................................................................... 35 
2T10.3.2T 
2TSample Size Determination2T .................................................................................................................. 36 
2T10.4.2T 
2TData Analysis2T........................................................................................................................................ 36 
2T10.4.1.2T 
2TTiming of Analyses2T ................................................................................................................ 36 
2T10.4.2.2T 
2TAnalysis Populations 2T ............................................................................................................. 36 
2T10.4.3.2T 
2TPooling of Data2T ...................................................................................................................... 37 
2T10.4.4.2T 
2TStatistical Analysis of Primary Endpoint(s) 2T ........................................................................... 37 
2T10.4.5.2T 
2TStatistical Analysis of Secondary Endpoint(s) 2T ....................................................................... 37 
2T10.4.6.2T 
2TSubgroup Analysis2T ................................................................................................................ 37 
2T11.2T 
2TEthical and Regulatory Considerations 2T ........................................................................................................ 37 
2T11.1.2T 
2TStatement of Compliance2T ..................................................................................................................... 37 
2T11.2.2T 
2TCompliance Responsibilities 2T ................................................................................................................ 38 
2T11.3.2T 
2TInformed Consent2T ................................................................................................................................. 39 
2T11.4.2T 
2TIndependent Ethical Review2T ................................................................................................................. 39 
2T11.5.2T 
2TConflict of Interest2T ................................................................................................................................ 39 
2T11.6.2T 
2TEmergency / Compassionate Use2T ........................................................................................................ 40 
2T11.7.2T 
2TConfidentiality2T ....................................................................................................................................... 40 
2T11.8.2T 
2TStudy Discontinuation or Suspension2T .................................................................................................. 40 
2T12.2T 
2TReferences2T ....................................................................................................................................................... 41 
 
 
 
 
 

 
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1. 
Introduction 
1.1. Disease 
Lower extremity peripheral artery disease (PAD) is a condition in which blood flow in the lower 
limb arteries has been partially or entirely blocked, most commonly as a result of 
atherosclerotic lesions within the vessel lumen.P1
P PAD is a common condition, and affects 
millions of individuals worldwide.1-3 In addition to being closely associated with risk factors 
such as smoking, diabetes mellitus, and race,1,4 PAD becomes increasingly likely with 
advancing age. PAD affects between 3% and 14% of the general population, but may be 
present in over 30% of those greater than 70 years of age.5-7 
As PAD progresses, the disease may cause intermittent claudication during activity, and, in 
more severe cases, pain at rest or loss of tissue in the feet and legs. If not adequately 
addressed, PAD is associated with significant morbidity, and may ultimately result in disability, 
loss of the affected limb, and death.8 The progression of PAD is commonly described using 
Rutherford and Fontaine clinical categories as described in Tables 1 and 2. 
 
Table 1: Rutherford Clinical Categories9 
Grade 
Category 
Clinical description 
Objective criteria 
0 
0 
Asymptomatic—no hemodynamically 
significant occlusive disease 
Normal treadmill or reactive 
hyperemia test 
I 
1 
Mild claudication 
Completes treadmill exercise†; AP 
after exercise >50 mmHg but at least 
20 mmHg lower than resting value 
2 
Moderate claudication 
Between categories 1 and 3 
3 
Severe claudication 
Cannot complete standard treadmill 
exercise† and AP after exercise < 50 
mmHg 
II* 
4 
Ischemic rest pain 
Resting AP <40 mmHg, flat or barely 
pulsatile ankle or metatarsal PVR; TP 
<30 mmHg 
III* 
5 
Minor tissue loss—nonhealing ulcer, 
focal gangrene with diffuse pedal 
ischemia 
Resting AP <60 mmHg, ankle or 
metatarsal PVR flat or barely pulsatile: 
TP <40 mmHg 
6 
Major tissue loss—extending above 
TM level, functional foot no longer 
salvageable 
Same as category 5 
AP, Ankle pressure; PVR, pulse volume recording; TP, toe pressure; TM, transmetatarsal. 
*Grades II and III, categories 4, 5, 6, are embraced by the term critical limb ischemia. 
†Five minutes at 2 mph on a 12% incline 
 
 
 
 
 
 

 
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Table 2: Rutherford Categories vs Fontaine Categories 
 
 
1.2. Historical Treatments  
A number of options exist for the treatment of PAD. These interventions can be grouped into 
four general categories: (a) behavioral modification, such as smoking cessation or increased 
exercise; (b) pharmacologic management of certain risk factors, including dyslipidemia and 
hypertension; (c) revascularization using minimally invasive endovascular techniques, and (d) 
revascularization using open surgical methods such as endarterectomy or bypass.4,8,10,11 The 
appropriate choice of therapy is heavily dependent upon the severity and location of 
disease.4,11 
Due to the regular motion and unique combination of mechanical forces to which the 
superficial femoral artery (SFA) and popliteal artery (PA) are subjected, these vessels are 
predisposed to the formation of atherosclerotic plaque, even after receiving an initial 
treatment.5,12 Physicians must carefully consider the challenges specific to these arteries, as 
well as the severity of disease present, in determining which intervention is most appropriate. 
In the TASC II document outlining management strategies for PAD, Norgren et al.13 proposed 
a uniform system of classification for femoropopliteal lesions. In this system, lesions are 
assessed based on length, complexity, and location within the vessel(s), and assigned a 
designation from Type A (least severe) to Type D (most severe). In 2011, Tenderra et al30 
updated the guideline recommendations for endovascular treatment as a first option for Type 
A, B, and C lesions, and surgical bypass for Type D lesions (Table 3). A primary endovascular 
approach may also be considered in TASC D lesions in patients with severe comorbidities and 
the availability of an experienced interventionist.30 
 
Table 3: TASC II Recommendations for Treatment of Femoropopliteal Disease 
Lesions 
Recommended 
treatments 
Type A 
lesions 
・ Single stenosis ≤10 cm in length 
・ Single occlusion ≤5 cm in length 
Endovascular 
therapy is the 
treatment of choice. 
Type B 
lesions 
・ Multiple lesions (stenoses or occlusion), each ≤5 cm 
・ Single stenosis or occlusion ≤15 cm not involving the infra 
geniculate popliteal artery 
Endovascular 
therapy is the 
preferred treatment. 

 
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・ Single or multiple lesions in the absence of continuous tibial 
vessels to improve inflow for a distal bypass  
・ Heavily calcified occlusion ≤5 cm in length 
・ Single popliteal stenosis 
Type C 
lesions 
・ Multiple stenoses or occlusions totaling >15 cm with or without 
heavy calcification  
・ Recurrent stenoses or occlusions that need treatment after 
two endovascular interventions 
Endovascular 
therapy is the 
preferred treatment. 
Type D 
lesions 
・ 
Chronic total occlusions of CFA or SFA (>20 cm, involving the 
popliteal artery) 
・ 
Chronic total occlusions of popliteal artery and proximal 
trifurcation vessels 
Surgery is the 
treatment of choice.  
 
Although surgical revascularization is very effective, endovascular treatment is a first-line 
treatment for SFA/PA disease, due both to the reduction in significant risk of complications and 
to the increasing effectiveness of less invasive endovascular procedures.1,9 Endovascular 
revascularization can be accomplished using a number of procedural options, including 
percutaneous transluminal angioplasty (PTA) or the implantation of an endoluminal stent.14 
PTA is a well-established minimally invasive treatment for disease in the superficial femoral 
and popliteal arteries (SFA/PA). With restenosis rates of 40-60% after 6 to 12 months, many 
patients require additional percutaneous or surgical interventions to address their recurrent 
symptoms.16-18 Alternative treatments to inhibit restenosis are needed. Drug-coated balloons 
have shown lower late lumen loss and Target lesion revascularization rates compared to 
uncoated balloons as noted in the FEMPAC, THUNDER, PACIFIER and In.Pact SFA trials.19-21 
Paclitaxel has been approved for human use for over 20 years in cancer therapy at a dose 
much more than 10 times higher than the dose coating currently used in available drug-coated 
balloons.22 Treating peripheral arterial disease with a paclitaxel-coated balloon may provide 
better long term patency compared to uncoated balloons without leaving any permanent 
implant behind. 
 
1.3. Study Device Description 
W. L. Gore & Associates, Inc. (Gore) has developed and manufactures the GORE® Drug-
Coated PTA Balloon Catheter (GORE® DCB Catheter) to offer clinicians an alternative 
percutaneous transluminal angioplasty device indicated for use in treating patients with 
obstructive disease of peripheral blood vessels. 
The GORE® DCB Catheter consists of an over-the-wire balloon catheter with a drug-coated 
nylon/ePTFE composite balloon at the distal tip (Figures 1). The composite balloon consists of 
a nylon layer on the innermost surface of the balloon and an ePTFE layer on the outermost 
surface of the balloon and serves as a coating substrate. The composite balloon is coated with 
a formulation that includes the drug paclitaxel, coated at a concentration of 3.5µg/mm2, and 
the excipients stearic acid and tromethamine (tris). The device component physically dilates 
the vessel lumen by PTA, and the drug component is intended to reduce the proliferative 
response that is associated with restenosis. 
 

 
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Figure 1.  GORE® Drug-Coated PTA Balloon Catheter 
 
The GORE® DCB Catheter consists of a proximal hub, dual lumen shaft, and a distal dilation 
balloon (Figure 1). The central lumen extends to the distal tip and is used for flushing and 
guidewire introduction with a diameter of 0.035”. The balloon inflation lumen is used to inflate 
and deflate the balloon. Two radiopaque platinum-iridium markers indicate the working length 
of the balloon and facilitate fluoroscopic visualization of the balloon during delivery and 
placement. 
The configurations of the GORE® DCB Catheter that will be studied during the clinical 
investigation in Europe are 4, 5, and 6mm in diameter and 40, 80,120, 150mm in length. 
The composite balloon of the GORE® DCB Catheter is coated with a mixture of paclitaxel 
(active ingredient) and two excipients (inactive ingredients). Descriptions of the active and 
inactive ingredients are provided below. 
UActive Ingredient (Paclitaxel) 
The GORE® DCB Catheter coating contains paclitaxel, an anti-proliferative pharmaceutical 
agent that specifically binds to and stabilizes microtubules. By blocking microtubule 
depolymerization, paclitaxel inhibits smooth muscle cell and fibroblast proliferation and 
migration as well as secretion of extracellular matrix. The combination of these effects results 
in the inhibition of neointimal hyperplasia and therefore restenosis. 
UInactive Ingredients (Excipients) 
The GORE® DCB Catheter contains two excipients or inactive ingredients. Information 
regarding the two excipients that are mixed with the paclitaxel and applied to the composite 
balloon is provided below: 
 
Tromethamine (tris) is widely used as a component of buffer solutions and is also a 
common inactive ingredient in many intravenous and intravascular pharmaceutical 
solutions/injections. 
 
Stearic acid is widely used as a surfactant and softening agent in the production of 
cosmetics such as shampoos, soaps and shaving cream products and in the 
preparation of dietary supplements. Stearic acid is a common inactive ingredient in 
many pharmaceutical preparations, including oral capsules/tablets, topical 
solutions/ointments/creams, vaginal tablets/creams, and subcutaneous implants. 
Gore is the legal manufacturer of the GORE® DCB Catheter. 
 
1.4. Pre-Clinical Data 
Gore has performed the following pre-clinical testing on the GORE® DCB Catheter – i) in vitro 
testing; ii) biocompatibility testing per ISO 10993-1; iii) in vivo animal studies.  See the 
Investigators Brochure (IB) for detailed descriptions and results of these studies. 
 
 
 

 
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1.5. Clinical Data 
The GORE® Drug-Coated PTA Balloon Catheter has not been evaluated clinically. However, a 
number of commercially available drug-coated balloon catheters relevant to the proposed 
clinical study, have been evaluated. See the IB for adverse event information from these 
studies. 
 
2. 
Study Objectives 
2.1. Primary Objective(s) 
The primary objectives of the GORE® DCB Catheter clinical investigation is to evaluate the 
performance and the safety of the GORE® DCB Catheter in the treatment of de novo and 
restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries (SFA/PA) of 
patients with symptomatic PAD.  
2.2. Secondary Objective(s) 
The secondary objectives of the GORE® DCB Catheter clinical investigation is to assess 
procedural success and the long term performance and safety of the GORE® DCB Catheter in 
the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and 
popliteal arteries (SFA/PA) of patients with symptomatic PAD. 
 
3. 
Study Design 
3.1. Description of Study Design 
Previous DCB studies that were intended to supply clinical data for CE marking have used 
uncoated PTA as a comparator for the test DCB. Given the prominent role that uncoated PTA 
balloons continue to play in the endovascular management of PAD lesions, peer-reviewed 
published data from uncoated PTA balloons were used as the starting point for calculation of a 
performance goal. 
Establishing the safety and performance of the GORE® DCB Catheter by comparison with a 
performance goal is appropriate given the maturity and similarity of the procedure, device, and 
technology to currently CE marked DCBs. Additionally, there has been an accumulation of a 
large volume of applicable, high quality clinical data in recent years. The clinical studies that 
supplied data for performance goal calculation demonstrate considerable homogeneity. 
This study is a prospective, multi-center, single-arm study characterizing outcomes in subjects 
with PAD lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® 
DCB Catheter. 
A maximum of ten (10) Clinical Investigative Sites (referred to as “Sites” in the remainder of 
this document) in Germany will participate in this study. The Sponsor shall maintain an 
updated list of principal investigators, investigation sites, and institutions. This list shall be kept 
separately from this Protocol. Fiftytwo (52) patients will be enrolled in this study with a limit of 
twelve (12) Subjects enrolled per Site. The anticipated accrual rate is approximately nine (9) 
Subjects per month, across all sites, for a total accrual period of approximately 6–8 months. 
Patients may be enrolled into the study provided all inclusion and no exclusion criteria are met 
as specified in Section 4. Subjects will be evaluated through hospital discharge and return for 
follow-up visits at 30 days, 6 months, 12 months, and 24 months post treatment.  

 
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Total estimated duration of the study is approximately 30 months. 
Bias will be controlled by strict adherence to the study protocol. Sites will be monitored for 
compliance with study protocol, including subject eligibility criteria. 
The study will be conducted in a staged manner. The first 10 subjects will be enrolled at a 
single institution by the Coordinating Investigator. Pharmacokinetic testing for plasma 
paclitaxel levels will be collected and safety data reviewed prior to continuing study enrollment 
at all sites.  Enrollment will continue at all sites following CEC/DSMB review and 
recommendation to continue, and the German competent authority acceptance of that 
recommendation. See section 8.2.1 for more detail. 
 
3.2. Study Endpoints 
3.2.1. 
Definitions 
Acute Device Success: Successful delivery, inflation, deflation, and retrieval of the 
intact GORE® DCB Catheter without burst less than the rated burst pressure. 
Acute Procedural Success: Procedural success without stenting is defined as <50% 
residual stenosis (investigator’s estimation) at the conclusion of the Index procedure 
without Major Adverse Event prior to discharge or at 24 hours whichever is earlier. 
Procedural success with Provisional Stenting is defined as <30% residual stenosis 
(investigator’s estimation) at the conclusion of the Index procedure with Provisional 
Stenting without Major Adverse Event prior to discharge or at 24 hours whichever is 
earlier. 
Ankle Brachial Index (ABI): The highest ankle systolic pressure measured in the 
Target limb divided by the highest brachial systolic pressure in either arm. 
Clinically-Driven Target Lesion Revascularization (CD TLR): Revascularization 
occurring within the Target lesion(s), after conclusion of the Index procedure, with at 
least one of the following: i) evidence of new symptoms, or ii) drop of ABI >20% or 
>0.15 compared with post procedure ABI, or iii) Target lesion diameter stenosis of 
>50% as determined by duplex ultrasound or angiography (images will be reviewed 
by an imaging core lab). CD TLR will be adjudicated by a CEC / DSMB. 
Clinically-Driven Target Vessel Revascularization (CD TVR): Revascularization of 
the Target vessel, after conclusion of the Index procedure, with at least one of the 
following: i) evidence of new symptoms, or ii) drop of ABI >20% or greater than >0.15 
compared with post procedure ABI, or iii) Target vessel diameter stenosis of >50% as 
determined by duplex ultrasound or angiography (images will be reviewed by an 
imaging core lab). CD TVR will be adjudicated by a CEC / DSMB. 
Dissection (NHLBI Classification): 
Type A: minor radiolucent areas within the lumen during contrast injection with little or 
no persistence of contrast after the dye has cleared. 
Type B: parallel tracts or a double lumen separated by a radiolucent area during 
contrast injection, with minimal or no persistence after dye clearance. 
Type C: appear as contrast outside the lumen (“extraluminal cap”) with persistence of 
contrast after dye has cleared from the lumen. 

 
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Type D: spiral (“barber shop pole”) luminal filling defects, frequently with excessive 
contrast staining of the dissected false lumen. 
Type E: appear as new, persistent filling defects within the lumen. 
Type F: those that lead to total occlusion of the lumen without distal antegrade flow. 
Index procedure: Initial treatment of the Target lesion with a GORE® DCB Catheter. 
Late Lumen Loss (LLL): The difference in minimum lumen diameter of the Target 
lesion between the time points immediately post-intervention angiography and the 6 
month follow-up angiography or at the time of a Clinically Driven Target Lesion 
Revascularization (CD TLR), whichever is earlier. 
Major Adverse Event (MAE): i) death, ii) Clinically Driven Target Vessel 
Revascularization (CD TVR), or iii) Major Amputation. 
Major Amputation: Removal of the lower limb above the metatarsals, resulting from 
a vascular event, in the Target limb. 
NHLBI Classification: National Heart, Lung and Blood Institute classification of 
dissection. 
Patency: Freedom from total occlusion. 
Primary Assisted Patency: Blood flow maintained with or without reintervention in 
the originally treated Target lesion(s), including the proximal and distal margins 
covered by the GORE® DCB Catheter. 
Primary Patency: Freedom from CD TLR and freedom from restenosis as 
determined by Color Doppler Ultrasound (CDUS) peak systolic velocity ratio (PSVR) 
≤ 2.4. In cases where PSVR cannot be determined, or is determined to be inaccurate 
by the independent ultrasound core laboratory, reduction in luminal diameter within 
the treated region must be ≤50% as adjudicated by the core laboratory. 
Provisional Stenting: Placement of a stent at the Target lesion at the time of the 
Index procedure after acute device success due to visually estimated residual 
stenosis ≥ 50% or flow-limiting dissection. 
Rutherford Category [28]: 
Category 0 – Asymptomatic, no hemodynamically significant occlusive disease 
Category 1 – Mild claudication 
Category 2 – Moderate claudication 
Category 3 – Severe claudication 
Category 4 – Ischemic rest pain 
Category 5 – Minor tissue loss, non-healing ulcer, focal gangrene with diffuse pedal 
ischemia 
Category 6 – Major tissue loss, extending above trans-metatarsal level, functional 
foot no longer salvageable 
Secondary Patency: Freedom from surgical bypass of the treated region. 
Target lesion: The atherosclerotic lesion treated during the Index procedure. 

 
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Target Lesion Revascularization (TLR): After conclusion of the Index procedure, 
any reintervention of the Target lesion by means of a percutaneous vascular 
intervention, surgical bypass, thrombolysis, or other invasive means, as adjudicated 
by the CEC / DSMB. 
Target limb: The infrainguinal portion of the limb on which the index procedure is 
performed. 
Target vessel: The SFA/PA in the Target limb. 
Target Vessel Revascularization (TVR): After conclusion of the Index procedure, 
any reintervention of the Target vessel by a percutaneous vascular intervention, 
surgical bypass, thrombolysis, or other invasive means, as adjudicated by the CEC / 
DSMB. 
Technical Success: Acute Device Success and investigator visual estimate of <50% 
diameter residual stenosis of the Target lesion during the Index procedure without 
Provisional Stenting. 
Treated region: Region containing the Target lesion(s) covered by the study 
device(s), during the Index procedure. 
Treated region thrombosis:  an occlusion at the treated region attributable to 
thrombus formation that is rapidly evolving as confirmed by the sudden onset of 
symptoms within 14 days of imaging, and documented by duplex ultrasound and 
angiography of the index vessel. 
 
3.2.2. 
Primary Endpoints 
 
Performance: Six month late lumen loss (LLL) as determined by the angiography 
core lab. 
 
Safety: A composite 30-day safety endpoint of freedom from Major Adverse 
Events (MAE), defined as i) death, ii) Clinically-Driven Target Vessel 
Revascularization (CD TVR), or iii) amputation above the metatarsals, resulting 
from a vascular event, in the treated leg (Target limb amputation) 
 
3.2.3. 
Secondary Endpoints 
 
Acute Device Success 
 
Acute Procedural Success 
 
Technical Success 
 
Treated region thrombosis 
 
% of subjects that require Provisional Stenting 
 
Freedom from MAEs at 1, 6, 12, and 24 months post-Index procedure as 
adjudicated by the CEC / DSMB 
 
Freedom from TVR at 1, 6, 12, and 24 months post-Index procedure as 
adjudicated by the CEC / DSMB 

 
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 
Freedom from CD-TVR at 1, 6, 12, and 24 months post-Index procedure as 
adjudicated by the CEC / DSMB 
 
Freedom from TLR at 1, 6, 12, and 24 months post-Index procedure as 
adjudicated by the CEC / DSMB 
 
Freedom from CD-TLR at 1, 6, 12, and 24 months post-Index procedure as 
adjudicated by the CEC / DSMB 
 
Rutherford category change from pre-Index procedure to 1, 6, 12, and 24 months 
post-Index procedure 
 
ABI change from pre-Index procedure to 1, 6, 12, and 24 months post-Index 
procedure 
 
Quality of life change from pre-Index procedure to 1, 6, 12, and 24 months post-
Index procedure 
 
Primary patency at 1, 6, 12, and 24 months post-Index procedure 
 
Assisted primary patency at 1, 6, 12, and 24 months post-Index procedure 
 
Secondary patency at 1, 6, 12, and 24 months post-Index procedure 
 
4. 
Study Population 
4.1. Description of Population 
Patient Population – patients with symptomatic PAD of the SFA/PA.  
Study Subject Population - those patients with symptomatic PAD of the SFA/PA meeting the 
following inclusion and exclusion criteria will be eligible for screening for participation in this 
study. 
The study has been designed with standard eligibility criteria to enroll subjects for whom the 
study device is intended to treat. Only patients who meet all of the Inclusion Criteria and none 
of the Exclusion Criteria will be enrolled. 
 
4.2. Inclusion Criteria 
To be considered candidates for this study, patients must meet all of the following criteria: 

 
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1. At least 20 years of age at the time of informed consent signature. 
2. Subject is willing to provide a signed Informed Consent Form. 
3. PAD patients with Rutherford Class 2 - 4 in the target limb, with no active ulceration or 
tissue loss due to arterial disease in either leg.  Walking distance limitation should not be 
caused by the contralateral leg or concomitant diseases, e.g. pain in the hip joint. 
4. Reasonable expectation of survival of at least 1 year after the Index procedure. 
5. Patient is capable of complying with the Protocol requirements, including follow-up visits. 
6. Patient is not a candidate for conservative therapy or has undergone conservative therapy 
that was not successful. 
7. Vasculature in the target limb meeting angiographic inclusion criteria. To be eligible for 
inclusion in the study, patients must meet all of the following criteria, assessed 
angiographically prior to the Index procedure: 
7(a). De novo or restenotic lesions, of the SFA/PA. The lesions must be located in the 
region beginning at the origin of the superficial femoral artery and ending ≤2 cm 
below the tibial plateau and ≥1 cm above the origin of the tibial/peroneal trunk. 
7(b). One Target lesion, which may include an area of the vessel with one or more 
regions of luminal narrowing ≥70% where the multiple single lesions are separated 
by ≤2 cm between the lesions, visually estimated by the physician. 
7(c). Total occlusions are allowed. 
7(d). Cumulative lesion length 30 - 150 mm, visually estimated by the physician. 
7(e). Reference vessel diameter of 4 - 6 mm, visually estimated by the physician. 
7(f). At least one patent tibial artery or peroneal artery (<50% stenosis angiographically) 
from the origin to the ankle of the target limb that does not require planned 
intervention at the time of the Index procedure or within 12 months of enrollment. 
7(g). Only one index limb is to be treated in the study. 
7(h). Guidewire has successfully traversed the Target lesion and is within the true lumen 
(reentry devices are not allowed). 
7(i). Target lesion has been successfully pre-dilated (no major flow limiting dissections or 
residual stenosis after pre-dilation >50%, visually estimated by physician) with a 
plain balloon 1 mm below the reference vessel diameter and a minimum of one (1) 
minute balloon inflation. 
 
4.3. Exclusion Criteria 
Patients will be excluded from the study if they meet one or more of the following criteria: 
1. Prior enrollment in this study. 
2. Surgical or endovascular access of the Target limb/vessel within the previous 30 days. 
[NOTE: Target limb catheterizations done for the purposes of planning the Index 
procedure are allowed within 30 days of the Index procedure if no treatment is performed. 
Catheterization or access of the Target limb for treatment of inflow disease is allowed 
during the Index procedure.] 

 
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3. Prior treatment of the Target lesion with PTA within 90 days. 
4. Prior treatment of the Target lesion with drug-coated balloon. 
5. Prior treatment of the Target vessel with stenting. 
6. Prior treatment of the Target vessel with bypass. 
7. Iliac artery inflow lesions that cannot be successfully treated during the Index procedure. 
8. Known outflow lesions requiring treatment during the Index procedure. 
9. Other than 
15Tplain old balloon angioplasty (15TPOBA), procedures required at the time of the 
Index procedure to facilitate the deployment of the study device and to treat the Target limb. 
10. Significant disease in all three Infrapopliteal vessels (as determined by the Investigator). 
11. Acute or subacute thrombus or arterial aneurysm (>1.5 x healthy adjacent vessel diameter) 
in the Target limb. 
12. Severe calcification that renders the Target lesion non-dilatable. 
13. Acute or chronic renal dysfunction (serum creatinine level ≥2.5 mg/dl or patients on 
dialysis) at the time of the Index procedure. 
14. Untreated pre-procedural hemoglobin <10 g/dL. 
15. Coagulopathy manifested by platelet count <100,000 or INR >2.0 (INR is only required in 
patients who have taken warfarin within 2 weeks of enrollment). 
16. Contraindication to PTA treatment with a paclitaxel-coated balloon. 
17. Known hypersensitivity or contraindications to nitinol, aspirin, heparin, clopidogrel, 
ticlopidine or paclitaxel, and sensitivity to contrast media not amenable to premedication. 
18. Myocardial infarction within 30 days prior to the Index procedure. 
19. Planned surgical or endovascular procedure of the target limb ± 30 days of Index procedure. 
20. Planned amputation of the target limb. 
21. Septicemia (including bacteremia) or uncontrolled infection. 
22. Any co-morbid condition that precludes compliance with this protocol. 
23. Women who are known or suspected to be pregnant or intend to become pregnant at the 
time of the informed consent. 
24. Women who are breast feeding. 
25. Men who intend to father children. 
26. Concomitant medical illness associated with a life-expectancy of less than one year. 
27. Patients with active vasculitis. 
28. Patients with active tumor disease related to cancer. 
29. Patients who are concurrently participating in an investigational study when such 
participation could confound the treatment or outcomes of this study. 
30. Any other factor identified by the investigator that would disqualify the prospective subject 
from participation in the study. 
 
5. 
Study Procedures/Evaluations 
For this study it is expected that the sites will follow this protocol, to ensure scientifically sound 
evaluation of outcomes.  Key items include but are not limited to: 

 
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 
All protocol requirements are to be followed. 
 
Only POBA procedures at the time of the Index procedure are to be performed to facilitate the 
deployment of the study device and to treat the Target limb. 
 
Patients with prior treatment of the Target lesion with PTA within 90 days are not to be 
enrolled. 
 
Patients that have had prior treatment of the Target lesion with drug-coated balloon, with 
stenting, or with bypass are not to be enrolled. 
 
All required follow-up visits are to be performed. 
 
The 6 months angiography for all enrolled subjects is to be performed. 
 
The required images are to be sent in an analyzable format to the CoreLab. 
 
All used and unused Gore devices are to be returned, as directed.   
There are no additional, known or foreseeable factors that may compromise the outcome of the 
clinical study or the interpretation of results. 
 
5.1. Study Procedures and Evaluation Schema (Figure 2) 
 

 
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Figure 2: Study Procedures 
and Evaluation Schema 

 
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5.2. Table 4: Schedule of Events 
 
Screening & 
Pre-procedure 
Procedure 
Post-procedure / 
Discharge 
14 day Follow-up2 
1-, 12-, and 24-month 
Follow-up 
6-month Follow-up 
Unscheduled Visit or 
Reintervention 
Informed consent 
X 
 
 
 
 
 
 
Demographics and medical history 
X 
 
 
 
 
 
 
Antiplatelet and anticoagulant medications 
X 
X 
X 
 
X 
X 
X 
Rutherford category 
X 
 
 
 
X 
X 
X 
ABI 
X 
 
 
 
X 
X 
X 
Blood tests (CBC, creatinine) 
X 
 
 
 
 
 
 
Pregnancy test (if applicable) 
X 
 
 
 
 
 
 
Quality of life questionnaires 
X 
 
 
 
X 
X 
X 
Angiogram 
 
X 
 
 
O 
X 
O/X1 
Adverse events 
 
X 
X 
X2 
X 
X 
X 
Duplex ultrasound 
X 
 
 
 
X 
X 
X 
Pharmacokinetic testing for plasma 
paclitaxel level  
X2,3 
 
X2,3 
 
 
 
 
X = required; O = To be collected when available; X1 = required for reinterventions 
X2 = required for the first 10 subjects enrolled only 
X3 = plasma collected at the following time points: pre-procedure, immediately post procedure, 1 hour 
post procedure, 3 hours post procedure and at 24 hours post procedure or at discharge whichever is 
sooner 
 
5.3. Informed Consent Process 
All patients must provide informed consent prior to any study related procedures being 
performed. The case history (i.e., source documents/Subject chart) for each Subject shall 
document that such informed consent was obtained. The EC-approved consent form will be 
signed and personally dated by the Subject, and the person who conducted the informed 
consent discussion. The original signed informed consent form will be retained in the Subject 
records. A copy of the informed consent document will be given to the Subject for their 
records. 
 
5.4. Pre-Screening / Screening 
The pre-screening procedure will involve reviewing existing patient health information to 
identify patients with symptomatic PAD who may be eligible for study enrollment. Patients who 
may be eligible for enrollment based upon pre-screening will be provided with an EC-approved 
ICF describing this study, as well as any additional information required to make an informed 
decision about their participation. No study procedures or evaluations outside of routine 
standard of care may be performed before obtaining written informed consent from the patient. 
All patients who sign an ICF will be considered entered into the screening phase of the study. 

 
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Once informed consent has been given by the patient, complete baseline data should be 
collected prior to initiation of the Index procedure. Baseline data may include existing health 
information collected following routine standard of care. 
The following baseline evaluations will be used to determine whether the patient meets non-
angiographic eligibility criteria for the study. These evaluations will be conducted at the pre-
procedure screening visit(s) or, if collected following routine standard of care, must have been 
completed prior to informed consent being given, per timelines defined below for each item: 
Within 7 days prior to Index procedure: 
 
Urine Pregnancy test (if applicable): Pregnancy testing may be waived if a reasonable and 
prudent explanation is provided such as infertility, surgical sterilization, or post-
menopausal status. Urine Pregnancy test, if performed, will be conducted within 7 days 
prior to Index procedure. 
Within 30 days of Informed Consent: 
 
Demographics 
 
Medical history (including height and weight) 
 
Antiplatelet and anticoagulant medications 
 
Rutherford category 
 
Blood tests (RBC, WBC, Platelets, and Creatinine): If creatinine is measured multiple 
times prior to the Index procedure, the measurement closest to the Index procedure date 
will be used to qualify the patient for the study. 
 
Color Duplex Ultrasound 
Within 90 days of Informed Consent: 
 
ABI (routine standard of care collected within 90 days of Index Procedure) 
 
The following baseline evaluations must be collected after informed consent is provided by the 
patient and prior to the Index procedure: 
 
Quality of life questionnaires (EQ-5D, PAQ) 
 
Baseline pharmacokinetic testing for plasma paclitaxel level for first 10 subjects only 
 
A screening and enrollment log will be kept at each Site. Every patient providing informed 
consent will be entered in the log, and the date of written consent will be recorded. Final 
enrollment status and reasons for screen failure, where applicable, will also be entered for all 
patients providing informed consent. 
 
5.5. Enrollment   
After the baseline data has been collected, and the patient is found to meet all non-
angiographic eligibility criteria (Inclusion criteria 1-6 and Exclusion criteria 1-30), the 
angiographic criteria will be assessed. For the items that can only be confirmed 
angiographically on the day of treatment; the Target vessel and Target lesion will be assessed 
angiographically during the start of the interventional procedure, to determine whether they 
meet angiographic eligibility criteria (Inclusion criteria 7a-7i). 

 
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The patient is considered enrolled following successful pre-dilation of the lesion, and when the 
GORE® DCB Catheter enters the patient’s vasculature. 
 
5.6. Procedure 
Preparation of patients for the Index procedure should include initiation of an appropriate 
dosage of antiplatelet medication prior to the procedure, consistent with best medical practices 
and institutional standards. It is recommended that the following perioperative anticoagulation 
therapy be applied: loading dose of aspirin of 300 to 500 mg and a thienopyridine-class 
antiplatelet medication of 300 mg within 24 hours of the Index procedure or 2 hours post-
procedure. Heparin must be administered at the time of the Index procedure in a dose of at 
least 5000IU. 
A radiopaque ruler, marker pigtail, external measurement tape, or the calibration measurement 
from the imaging software must be used for all angiographic imaging. 
The balloon delivery system may be accessed from either ipsilateral antegrade or contralateral 
retrograde approach. A popliteal retrograde approach is allowed especially when an occluded 
lesion is treated. 
If needed, interventional treatment of the ipsilateral iliac artery for an in-flow and / or 
contralateral iliac artery for a catheter delivery will be performed during the Index procedure.  If 
attempted, this procedure must be successful in restoring in-flow prior to proceeding to the 
SFA/PA for balloon treatment. Such treatment will be consistent with best medical practices 
and institutional standards. 
Prior to balloon deployment, the vasculature of the Target limb will be visualized 
angiographically, and the dimensions of the Target vessel and Target lesion will be determined 
and recorded. Angiographic eligibility criteria will be assessed at this time; angiographic 
eligibility must include successful pre-dilation of the Target lesion. 
Pre-dilation of the Target lesion is intended to dilate the vessel segment to be treated, in order 
to prepare it for the dilation with the GORE® DCB Catheter and to assist the passage of the 
GORE® DCB Catheter through the vessel segment. The pre-dilation balloon should be 1 mm 
below reference vessel diameter, for vessel preparation. 
 
In order to avoid creating a region of vessel injury that is outside the boundaries of the area to 
be treated by the GORE® DCB Catheter (i.e. geographical miss), limit the longitudinal length of 
the pre-dilatation balloon to the Target lesion. If pre-dilation is unsuccessful, the patient is not 
eligible for study enrollment, and will be treated as per standard of care. Treatment of the 
Target lesion prior to GORE® DCB Catheter use is restricted to PTA with conventional 
angioplasty balloon catheters. Cutting, drug eluting, or other specialized balloons may not be 
used. Debulking of lesions is, likewise, not allowed. Additionally, using QVA or IVUS will be 
recommended to confirm vessel diameter measurements. 
The following data will be collected prior to use of GORE® DCB Catheter: 
 
Target lesion and Target vessel morphology 
 
Vascular access specifications 
 
Baseline angiographic images of the Target vessel, Target lesion, and runoff vessels 
 
Nominal diameter and length of balloons used in pre-dilation of the Target lesion 

 
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 
Maximum Balloon pressures 
 
Balloon inflation time 
 
Outcome of the pre-dilation 
 
Angiographic images confirming pre-dilation success 
 
If angiographic eligibility (Inclusion criteria 6a – 6i) is confirmed, the GORE® DCB Catheter use 
should be conducted in accordance with the Instructions for Use (See Appendix 1). 
Appropriate sizing for the balloon, introducer sheath, and guidewire are presented in Table 5. 
Enrollment in the study is complete when the GORE® DCB Catheter enters the patient’s 
vasculature. 
 
Table 5: GORE® DCB Catheter Sizing Table 
Balloon 
Diameter 
(mm)1, 2 
Balloon Working 
Length (mm)1, 2 
Catheter 
Working 
Length 
(cm) 
Introducer 
Sheath 
Size (Fr) 
Recommended 
Guidewire 
(inch) 
40 
80 
120 
150 
4 
X 
X 
X 
X 
135 
6 
0.035 
5 
X 
X 
X 
X 
135 
6 
0.035 
6 
X 
X 
X 
X 
135 
6 
0.035 
1  Rated Burst Pressure ≥ 14 atm for all diameters and lengths. 
2  Nominal Inflation Pressure is 6 atm for all diameters and lengths. 
 
The proximal and distal ends of the lesion will be identified using angiography prior to balloon 
deployment, and proper placement of the balloon will be monitored and confirmed using 
fluoroscopy. 
The drug, Paclitaxel, is coated on the surface of the GORE® DCB Catheter, which during 
dilatation comes into close contact with the vessel wall allowing the transfer of the drug to the 
adjacent tissue. Each GORE® DCB Catheter can only be used once for drug delivery. The 
dose has been selected on the basis of the animal experiments and the clinical experience 
with conventional drug coated balloons. 
Inflate the GORE® DCB Catheter for minimum 60 seconds at an inflation pressure that 
completely eliminates any balloon waisting and is at or above nominal pressure, but does not 
exceed the rated burst pressure (RBP) for that diameter balloon. Select the appropriate length 
device to completely cover the Target lesion (extending approximately 10 mm beyond the 
proximal and distal edge of the Target lesion). For longer lesions, multiple GORE® DCB 
Catheters may be used, with at least a 10 mm overlap between balloons. 

 
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Post dilation is allowed per operator discretion. Provisional Stenting of the Target lesion is 
reserved for patients with a persistent ≥50% residual stenosis (visually estimate) or >10 mmHg 
trans-lesional gradient, or flow-limiting dissection after repeated post dilation of a minimum of 3 
minutes. If treatment will require a provisional stent, a bare metal stent should be utilized for 
the Provisional Stenting. The bare metal stent that is selected should be long enough to cover 
the area that was suboptimally dilated, but to avoid geographic miss, the bare metal stent that 
is selected should be at least 5 mm shorter than the area treated by the GORE® DCB 
Catheter. 
Immediately following the procedure, vascular sheaths can be removed according to usual 
hospital practice and vascular closure devices may be used at the discretion of the 
Investigator in accordance with the manufacturer’s directions. 
With the exception of the GORE® DCB Catheter, the equipment used, imaging performed and 
medical devices used, during the index procedure, are standard of care. Each site will be 
responsible for using and maintaining the equipment and medical devices in accordance with 
the manufacturer’s directions and their institutional practices.  
Procedural complications arising after enrollment of an eligible subject should be treated as 
per investigator discretion and standard of care. 
The following data will be collected after the GORE® DCB Catheter and any post dilation 
balloons are use: 
 
Outcome of balloon deployment 
 
Nominal Balloon sizes/dimensions 
 
Maximum Balloon pressures 
 
Balloon inflation times 
 
Residual stenosis and/or pressure gradient 
 
Adverse event (AE) information 
 
Information on treatment of inflow disease 
 
Provisional stenting information – reason for Provisional stenting, manufacturer brand and 
size, post dilation location within original balloon segment, deployment issues with the 
stent 
 
Final angiographic images of treated lesion 
 
Pharmacokinetic testing for plasma paclitaxel level – immediately after procedure, 1 hour 
post procedure and 3 hours post procedure for first 10 subjects only 
 
The following data will be collected prior to discharge: 
 
Antiplatelet and anticoagulant medications 
 
AE information 
 
Pharmacokinetic testing for plasma paclitaxel level – at 24 hours or at discharge whichever 
is sooner for the first 10 subjects only 
 
All required angiographic images should be collected in accordance with the core lab imaging 
guidelines. Copies of required images will be submitted as described in Section 6.4. 

 
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Dual antiplatelet therapy will be required for 1 month post-procedure and can be extended for 
longer periods in case of Provisional Stent placement. The use of aspirin and a thienopyridine-
class antiplatelet medication is recommended, unless discontinuation or modification of this 
therapy is deemed medically necessary by a Site Investigator or a Sub-Investigator. After 1 
month post-procedure, aspirin is recommended at least 6 months. 
 
5.7. Repeat Interventions 
Study subjects requiring TVR/TLR after the Index procedure will continue to be followed at the 
specified study follow-up intervals until study completion. Appropriate reintervention therapies 
may be selected at the discretion of the Site Investigator or Sub-Investigator, although chosen 
therapies must be commercially available in Germany and may not be specifically 
contraindicated for use for such repeat intervention. The GORE® DCB Catheter may not be 
used in reintervention procedures. 
A CDUS is required prior to any subsequent angiography of the index limb, and the images 
must be submitted to the core lab (and to Sponsor if requested). Angiographic images of the 
treated lesion before and after reintervention are required, and shall be submitted to the core 
lab (and to Sponsor if requested) as described in Section 6.4. 
 
5.8. Follow-Up 
The first 10 consecutive subjects enrolled will complete a 14 day follow-up telephone call to 
assess any adverse event status. 
These 10 study subjects and all other study subjects enrolled will return to the Site for four 
scheduled follow-up visits throughout the course of the study. These visit intervals, as well as 
the acceptable time window for each visit, are listed in Table 6. 
Table 6: Follow-up Intervals and Associated Visit Windows 
Follow-up Visit 
Acceptable Visit Window 
1 month 
30 ± 7 days 
6 months 
182 ± 30 days 
12 months 
365 ± 45 days 
24 months 
730 ± 45 days 
 
The following data will be collected at the 1-, 6-, 12-, and 24- month follow-up intervals: 
 
Antiplatelet and anticoagulant medications 
 
Rutherford category 
 
ABI 
 
Quality of life questionnaires (EQ-5D, PAQ) 
 
AE information 
 
Duplex ultrasound 
 
Angiography (required for the 6 month interval, when available for all other follow-up 
intervals) 
 

 
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All images and associated data, including duplex ultrasound and angiographic imaging, should 
be collected in accordance with the imaging guidelines provided by the core lab. Copies of all 
images and associated data will be submitted to the core lab (and to Sponsor if requested) as 
described in Section 6.4. 
 
5.9. Subject Withdrawal from the Study 
Subjects can withdraw from this study at any time. In addition, if the investigator determines 
that continued participation may adversely affect the health of a subject, they can discontinue 
the participation of the subject at any time. When withdrawing the participation of a subject for 
any reason, the Site Investigator or Sub-Investigator records the date of discontinuation, the 
reason for discontinuation, and the subject’s condition at the time of discontinuation in the 
Subjects medical record and on the appropriate electronic case report form. If the 
discontinuation is caused by the development or worsening of AEs, information on the AEs 
should also be recorded in the subject’s medical record and on the appropriate electronic case 
report form. All data generated prior to subject withdrawal will be maintained, and study data 
will be used as appropriate. 
If the subject declines the six month angiographic follow-up, he/she will be asked to undergo 
clinical follow-up at six months and continue to be followed through the duration of the study. 
Subjects who have not voluntarily withdrawn from the study but fail to return for follow-up visits 
will be considered ‘lost to follow-up’ only after every effort has been made to encourage them 
to comply with protocol. Before a subject is considered “lost to follow-up”, the subject’s primary 
physician will be contacted to obtain clinical follow-up. Efforts to ensure that every enrolled 
subject completes every follow-up visit will be documented. 
It is important that the investigator encourage subjects to return for all required follow-up visits. 
The clinical study objectives may not be met if a significant number of subjects miss scheduled 
follow-up visits or are lost to follow-up. 
 
5.10. Subject Lost to Follow-Up 
A subject will be considered lost to follow-up and withdrawn from the study once they have 
missed two consecutive follow-up visits and three documented attempts have been made by 
the Investigator or designee to contact the subject or next of kin. One of the three documented 
attempts should include a certified letter or comparable communication. 
 
5.11. Subject Study Completion 
A subject has completed the study when: 
 
The subject completes the 24-month follow-up visit 
 
Surgical bypass of the Target lesion 
 
Death 
 
Voluntary withdrawal 
 
Investigator withdrawal 

 
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Subjects will not be provided with any medical care under this protocol by the Sponsor after 
study completion or withdrawal. It is expected that subjects will be treated according to 
hospital standard of care once they have completed the study or are withdrawn from the 
study. 
 
5.12. Device Deficiencies 
Device deficiencies are defined as inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety or performance. 2T15
2T A device deficiency may be attributable 
to a number of causes, including design, manufacturing, import, distribution, use, etc. 
Device Deficiency Reporting: All device deficiencies – even those that could have led to a SAE 
should be reported to the Sponsor immediately. The following information on each reported 
deficiency will be collected: 
 
Description of deficiency 
 
Date of occurrence 
 
Batch code and lot number of the affected device 
 
Related subject AE information (if applicable) 
 
6. 
Study Administration 
6.1. Training 
All investigators performing an intervention with the GORE® DCB Catheter must be trained on 
the Protocol, study device IFU and receive didactic training on the GORE® DCB Catheter from 
a Sponsor associate or designees prior to use of the study device. 
 
6.2. Monitoring 
Site monitoring for this study will be provided by InnoRa GmbH (Berlin, Germany). Monitoring 
oversight will be provided by the Sponsor. 
The Site monitors are qualified by training and experience to oversee the progress of the study 
at the Site and will verify that the Investigators and their staff understand and adhere to both 
the applicable regulatory requirements and the study Protocol. In addition, they may assist in 
resolution of any problems that may arise during the study. 
Site initiation will be performed to verify that each Investigator and his / her staff understands 
the Protocol, applicable regulations, and the Investigator’s obligations (including protecting the 
rights, safety, and welfare of subjects under the Investigator’s care). This visit will confirm that 
required documentation with the appropriate approval is in place prior to subject enrollment. 

 
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Site monitoring will occur to verify continuing adequacy of facilities and adherence to the study 
Protocol, the GCPs, and applicable regulations and laws that pertain to the conduct of the 
study. These activities will also include the review of the CRFs and source documentation, the 
timely submission of accurate records to the Sponsor, and the maintenance of proper records. 
A report will be written following each Site visit and a follow-up letter will be provided to the 
Site with a summary of findings. Details of the site monitoring will be covered in a Clinical 
Monitoring Plan and will outline the frequency of visits based on the number of subjects 
enrolled per site and site performance. It is expected that each site will be visited a minimum 
of one time per year and more often based on enrollment at the site. Each Site will also be 
visited at close-out to confirm that all documentation is complete and that Site personnel 
understand any ongoing responsibilities pertaining to the study. 
 
6.3. Device Accountability, Storage and Return 
A variety of sizes (diameter and lengths) of the GORE® DCB Catheters will be provided free of 
charge to the Investigators. GORE® DCB Catheter sizing information is provided in Table 5. 
The longest study device available is 150mm in length. The longest lesion to be treated is 
150mm in length. Due to overlap requirements this longest lesion length should be treated with 
a minimum of two study devices. Depending on the variety of sizes on hand at each site, it is 
estimated that the number of study devices to be used during this study will range from 52 
(one per subject) to 104 (two per subject for longest length lesion).  This number will be higher 
should more than two devices be required to successfully treat the target lesion. 
These devices may only be used under the supervision of the Investigator and in strict 
accordance with this Protocol and applicable laws and regulations. The device may only be 
used in subjects who sign the ICF, meet the inclusion / exclusion criteria set forth in this 
Protocol and the device may be used only as described in this Protocol. The Investigator will 
maintain accurate, detailed records of all devices received from the Sponsor, or the Sponsors 
designee, and the disposition of each device. Information collected on the Device 
Accountability Log include: date of receipt, catalog number and batch code (Lot # / Serial #), 
expiry date, date of use, subject identification, the date of return of used and unused devices. 
The Investigator will record each device used on the corresponding CRF and Device 
Accountability Log. The Investigator will notify the Sponsor immediately if any devices are 
damaged or unaccounted for. At each study site, the GORE® DCB Catheter will be kept at 
room temperature in locked storage to which only authorized study personnel have access. All 
other devices and medications required for patient treatment in this study will be provided by 
the hospital and treating Investigator / study personnel according to institutional practice. 
The study monitor will periodically check the supply of study devices held by the Investigator 
or his designee to verify accountability of all study devices. 
All used and unused GORE® DCB Catheters will be returned to the Sponsor or to the Sponsor 
designee after use or at the end of the trial or whenever the Sponsor requests the 
Investigators to return the devices, regardless of the reason. A specimen shipping kit will be 
made available to the Site for such return. The specimen shipping kit provides specific 
packaging and handling instructions for the specimen and contains a shipping container. 
The Sponsor will have the used GORE® DCB Catheter analyzed for the remaining drug on the 
balloon. Because of this, the used GORE® DCB Catheter should be prepared for return per the 
directions in the specimen shipping kit. 

 
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In the event that a GORE® DCB Catheters is opened but not used, return such device as 
explained in the specimen shipping kit. 
Upon completion or termination of the study or the Investigator’s participation in the study, or 
at the Sponsor’s request, the Investigator will return any remaining supply of the device to the 
Sponsor or dispose of the devices as directed by the Sponsor. 
 
6.4. Core Lab 
All ultrasound and angiographic images collected during the study will be analyzed by a core 
laboratory. The core lab services for this study will be provided by coreLab Black Forest 
GmbH, Medical Quality Analysis Center (Bad Krozingen, Germany). 
All Images will be collected in accordance with the imaging guidelines provided by the core lab 
and either sent via CD/DVD or uploaded thru an image transfer service provided by the core 
lab or other image transfer vendor. Sponsor may also request copies of images sent directly to 
the Sponsor. 
 
6.5. Protocol Deviations 
A Protocol deviation is defined as any change, divergence, or departure from the study design 
or procedures of a research protocol. The Investigator is responsible for promptly recording 
and reporting Protocol Deviations to the Sponsor and the reviewing EC per EC policy, if 
applicable. The Sponsor will determine the effect of the protocol deviation on the scientific 
soundness of the study and subject safety and determine if additional reports or actions are 
required. Additional action may include Site retraining, removal of devices from the Site, and / 
or Site termination. 
The Investigator must follow the protocol, except in the event of an immediate hazard(s) to a 
subject. The Investigator must report those deviations immediately to the sponsor. The 
Investigator will report the Protocol Deviation in accordance with the applicable regulations. 
 
6.6. Protocol Amendments 
The Sponsor will obtain EC approval and depending on national regulations, competent 
authority approval, and approval of other authorities (as applicable), on all amendments prior 
to implementation, in a timely manner. The Sponsor will assure and document proper training 
of Investigator and Site staff on all protocol amendments. 
 
6.7. Presence of Sponsor Representatives 
Subject to the Site’s approved ICF, Sponsor representatives may be present during study 
procedures to observe and provide technical assistance to the Investigator in the use of the 
device. The activities of these Sponsor representatives will be supervised by the Investigator. 
 
6.8. Access to Source Data/Documents 
Source data are defined as all information necessary for the reconstruction and evaluation of 
the Clinical Investigation. 

 
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The Investigator will keep all study records, source data and investigational devices available 
for inspection by the Sponsor, Sponsor’s monitors, EC, and regulatory authorities. 
 
6.9. Study Records Retention 
The Investigator will maintain complete, accurate and current study records as required by 
applicable regulatory requirements. Records will be maintained during the study and for a 
minimum of 15 years after study completion. Documents required for the Federal Office for 
Radiation Protection (Bundesamt für Strahlenschutz – BfS) must be maintained for 10 years. 
In any event, study records will not be disposed of, nor custody of the records transferred, 
without prior written Sponsor approval. 
Investigator records will include, but not be limited to: All correspondence with another 
investigator, an EC, the Sponsor, a monitor, or Regulatory Authority, including required 
reports: 
 
Records of receipt, use or disposition of a device that relate to: 
 
The type and quantity of device(s) received, the date(s) of its receipt, and lot or 
batch number or code mark and expiry date. 
 
The names of all persons who received, used, or disposed of each device. 
 
Records of each subject’s case history and exposure to the device. Case histories include 
the case report forms and supporting data including, for example, signed and dated 
consent forms and medical records, including, for example, progress notes of the 
physician, the individual’s hospital chart(s), and the nurses’ notes. Such records shall 
include: 
 
Documents evidencing informed consent. For any use of a device without 
informed consent, a written concurrence of a licensed physician and a brief 
description of the circumstances justifying the failure to obtain the informed 
consent is required. The case history for each individual shall document that 
informed consent was obtained prior to participation in the study. 
 
All relevant observations, including records concerning adverse device effects 
(anticipated and unanticipated), the information and date and condition of each 
subject upon entering the study, and information about relevant previous medical 
history and the results of all diagnostic tests. 
 
A record of the exposure of each subject to the investigational device, including 
the date and time of each use, and any other therapy. 
 
The protocol, any amendments, and documentation of any deviations from the protocol, 
including the dates and the reasons for such deviations. 
 
Any other records that Regulatory Authority requires to be maintained by regulation or by 
specific requirement for a category of investigations or a particular investigation. 
 
A signed Investigator Agreement. 
 
Any other records as required by the Regulatory Authority, the EC and the Sponsor. 
 
The Investigator will prepare and submit the following reports: 

 
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 
Withdrawal of EC approval: The Sponsor should receive information of the withdrawal of 
EC approval prior to the Investigator notice from the EC. The Investigator will confirm any 
withdrawal of approval within 5 working days after the Investigator has been notified of the 
withdrawal. 
 
Progress reports: Progress reports documenting the procedure, AEs and follow-up data 
concerning individual subjects will be submitted to the Sponsor on standardized CRFs. 
The Investigator may also be required to submit progress reports and final reports to the 
EC and to the Sponsor summarizing the Investigator’s experience during the study. 
 
(S)AEs and UADE Reports: (S)AEs and UADEs shall be reported as described in Section 
9. 
 
Device deficiencies: Device deficiencies shall be reported as described in Section 5.12. 
Device deficiencies that could have led to a SAE must be reported as described in Section 
9.1.4. 
 
Protocol Deviations shall be reported as described in Section 6. 
 
Other: Any other reports as reasonably requested by the Sponsor or required by 
Regulatory Authority. 
 
6.10. Publication Plan  
The International Committee of Medical Journal Editors (ICMJE) member journals have 
adopted a trials-registration policy as a condition for publication. This policy requires that all 
clinical trials be registered in a public trials registry. The Sponsor will register the study and 
post results as required by this policy and applicable any other local laws and regulations. 
It is the intent that the multicenter results of this study will be submitted for publication (in a 
peer reviewed journal). A publications committee will be established to review the multicenter 
results and develop publications. The publications committee is anticipated to consist of the 
Lead (National) PI (first author) and other enrolling physicians in the study, along with Sponsor 
representation. The timing of the multicenter publication may be dependent on regulatory 
submissions and approvals but is anticipated to occur within 12 -24 months after receiving CE 
Mark approval to commercially market the GORE® DCB Catheter. Individual Sites should 
coordinate requests for publication through the Sponsor or a publications committee. 
 
7. 
Data Collection and Submission 
The validated Clinical Data Management System (CDMS) for this study will be provided by Medrio, 345 
California Street, Suite 325, San Francisco, CA 94104. The Sponsor will keep a separate Clinical Data 
Management Plan describing the procedures for verification, validation and security of the CDMS. The 
Clinical Data Management Plan will describe and document procedures regarding data management 
processes for this investigation. 
7.1. Data Collection Methods  
This study will report clinical data using the Medrio eClinical application. The CDMS will be the 
database of record for the protocol and subject to regulatory inspections and quality assurance 
review. All users will be trained to use the CDMS and will comply with study specific guidelines 
/ instructions as well as applicable regulatory requirements. 

 
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Subject data will be collected using protocol-specific case report forms (CRF). Site staff will 
enter data directly into the CRF for transmission to the Sponsor. The Sites will be notified of 
any significant amendments to the CRFs. 
 
7.2. Data Clarification and Correction 
Once entered, data will be evaluated to confirm that it is complete, consistent and logically 
sound. If changes to the data in the CDMS are required, all changes, reasons for changes, 
and persons making the changes will be captured in the CDMS's audit trail. Sponsor will 
perform periodic data reviews throughout the entire study. Procedures and documentation for 
regular and ongoing data review are described in the Clinical Data Management Plan. 
 
7.3. CRF Completion Schedule 
CRFs will be completed and updated as soon as reasonably possible during or after each 
subject visit and monitoring visit. 
 
8. 
Risk Assessment  
8.1. Potential Risks 
The risks associated with the GORE® DCB Catheter for the treatment of PAD are expected to 
be similar to the risks associated with devices used for peripheral dilation catheterization 
procedures. 
Such risks associated with the peripheral dilation catheterization procedure using these 
devices include, but are not limited to: 
 
Abnormal heart rhythms 
 
Abrupt vessel closure 
 
Allergic reaction 
 
Aneurysm or rupture of the artery 
 
AV fistula 
 
Bleeding 
 
Death 
 
Dissection 
 
Embolization 
 
Femoral nerve compression with associated neuropathy 
 
Groin area bruising and discomfort 
 
Hematoma 
 
Infection 
 
Kidney failure 
 
Low blood pressure 
 
Perforation 

 
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 
Pseudoaneurysm 
 
Respiratory Failure 
 
Restenosis 
 
Stroke 
 
Total occlusion or thrombosis 
 
Vessel trauma that may require re-intervention or surgical repair  
 
Such risks associated with these devices, including the GORE® DCB Catheter, which might be 
associated with the addition of paclitaxel to a PTA balloon catheter include, but are not limited 
to: 
 
Allergic/immunologic reaction 
 
Alopecia 
 
Anemia 
 
Gastrointestinal symptoms 
 
Hematologic dyscrasia (including leukopenia, neutropenia, thrombocytopenia) 
 
Hepatic enzyme changes 
 
Histologic changes in vessel wall, including inflammation, cellular damage or necrosis 
 
Myalgia/arthralgia 
 
Peripheral neuropathy 
 
The adverse events (clinical harms) and adverse event rates reported at 1 and 2 years in both 
the Medtronic SFA I&II and the Bard LEVANT 2 trials were reviewed and can be found in 
Appendix 1 of the GORE® DCB Catheter IB.  It is expected that the adverse events and 
adverse event rates in the GORE® DCB Catheter trial will be similar to those observed in the 
Medtronic SFA I&II and LEVANT 2 trials.  This is expected because the GORE® DCB 
Catheter has shown similar safety and performance in animal studies to the DCBs studied in 
these trials and the patient populations are similar. 
The adverse events with occurrence rates greater than 5% from the above clinical studies are: 
Femoral artery stenosis, intermittent claudication, restenosis of the non-study vessel, 
peripheral artery occlusive disease, congestive cardiac failure, and coronary artery disease.  
These adverse events are typical for patients with PAD due to concomitant underlying disease 
and disease progress.  No paclitaxel-related events were reported. 
 
Other known risks:  
 
The additional radiation exposure of the 6 month angiography (pelvis-leg arteriography) 
is equivalent to a dose of approximately 10 mSv.  
 
The potential risk of loss of data confidentiality. Sponsor has taken necessary 
precautions in the data collection systems and by training the site personnel.  

 
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There may be unexpected risks that are not identified here or the occurrence and severity of 
risks can be different in a clinical study compared to routine clinical practice. Other than those 
listed in Section 8.1, Sponsor does not anticipate or expect any additional risks to study 
subjects. 
 
8.2. Minimization of Risks 
Potential risks associated with the use of the GORE® DCB Catheter may be minimized by the 
following activities: 
 
The sponsor has conducted risk management activities for the GORE® DCB Catheter 
according to ISO14971:2012. Risks remaining after the risk control measures have been 
implemented are acceptable and the effectiveness of these measures have been verified. 
The combined impact of the individual risks has been assessed and found to be 
acceptable. The benefit of the product has been assessed against the overall residual risk 
and determined that the medical benefit of the product outweighs the risk. The overall 
residual risk for this product is comparable to similar products. Therefore, overall residual 
risk has been evaluated for the GORE® DCB Catheter and has been deemed acceptable. 
All appropriate methods are in place to collect clinical information during the trial for the 
GORE® DCB Catheter. All risks related to the design, manufacturing and usability of the 
medical device have been reduced as far as possible. 
 
The Sponsor has performed qualification testing on the device and device components 
and appropriate quality control measures have been implemented into production. 
Investigators will be selected who are knowledgeable and experienced in PAD 
procedures. 
 
Comprehensive Site Investigator and staff training will be conducted to share information 
regarding design and proper use of the GORE® DCB Catheter. 
 
The Site Investigator, Sub-Investigators, Study Coordinator(s) or designee at each Site 
will be trained to the protocol and subject follow-up requirements. 
 
Protocol inclusion/exclusion criteria and follow-up schedules are designed to select 
appropriate subjects and identify potential complications early. Subjects will be assessed 
post-procedure and subsequently on a regular basis to collect information on the subject’s 
status and any reportable Adverse Events. 
 
Data completed by the Sites will be monitored to evaluate protocol compliance and for 
accuracy and subject safety. 
 
Safety and efficacy findings during the study will be shared with the Site Investigators to 
aid understanding of the device and potential complications associated with its use. 
 
An independent CEC / DSMB will meet regularly to review safety events occurring in the 
study. Once a combined CEC / DSMB is established, a charter will be created to include 
study stopping rules to protect the safety of study subjects, and describe the meeting 
schedule to review AEs. Termination or modification of the study may be recommended 
by the CEC / DSMB for any perceived safety concern based on clinical judgment, 
including, but not limited to, a higher than anticipated rate for any component of the safety 
endpoint, device failures resulting in AEs or unexpected SAEs. Study discontinuation or 
suspension will be in accordance with Section 11.8. 

 
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 
Possible interactions with concomitant medical treatments is not expected as such 
treatment will be consistent with best medical practices and institutional standards. No 
interactions with antiplatelet therapy or paclitaxel have been reported in other drug coated 
balloon trials. 
  
8.2.1. 
Early Safety Monitoring  
As a means to monitor subject safety during the early clinical experience, the 
following process will be followed: 
 
The first 10 consecutive subjects will be enrolled at a single center by the 
Coordinating Investigator. 
 
34TPharmacokinetic testing for plasma paclitaxel level will be performed at the 
following periods: 34Tpre-procedure, immediately post procedure, 1 hour post 
procedure, 3 hours post procedure and at 24 hours or at discharge whichever 
is sooner. The paclitaxel concentration data will be used to construct 
pharmacokinetic curves, calculate elimination half-life, calculate area under 
the curve and measure maximum concentration of paclitaxel in the blood 
stream.  
 
34TSite will complete a 14 day follow-up telephone call with these first 10 subjects 
to assess their adverse event status. The Site will make every attempt to 
complete this telephone call shortly after the end of the 14 day period. The 
telephone call with be documented in the subjects medical record and data 
will be entered into the EDC on the adverse event form (if appropriate). 
 
Once all 10 early safety monitoring subjects have reached 14 days post-
treatment or have discontinued (whichever is sooner) and a telephone 
interview has occurred, Sponsor will request that the site enter all known data 
into the EDC, the data will be verified by the Sponsor’s Clinical Research 
Monitor, and the EDC will be signed by the Coordinating Investigator. Sponsor 
will then export the AE / SAE data and provide it to the independent CEC / 
DSMB who will meet and provide a formal written recommendation to 
continue, modify, or stop the study. This recommendation will be provided to 
the German competent authority prior to continuation of further enrollment in 
the study. 
 
As stated in Section 8.2, the independent CEC / DSMB is responsible for 
developing stopping rules and evaluating the safety outcomes of all subjects 
relative to these rules. 
 
Once the Sponsor receives a positive response or approval from the German 
competent authority to continue enrollment in the study, enrollment will be 
opened to all Investigators and will continue until a total of 52 subjects are 
enrolled. If the recommendation is to modify the study, further enrollment will 
be stopped until such time as the modifications are approved by the German 
competent authority. If the recommendation is made to stop the study, the 
Sponsor will halt further enrollment. 

 
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 
As stated in 8.2, the CEC / DSMB will continue to monitor subject safety for 
the duration of the study and retains the ability to make recommendations to 
terminate or modify the study. 
 
This formal CEC / DSMB recommendation will be communicated to the 
Sponsor, German competent authority, and ethics committee(s).   
 
8.3. Summary of Expected Benefits 
The benefits of the GORE® DCB Catheter have not been determined because the device has 
not yet been evaluated in humans. However, because the GORE® DCB Catheter has 
demonstrated similar pharmacokinetics and safety in animal studies (see IB) as other 
commercially available DCBs, the clinical benefit is expected to be similar. Those benefits 
include, but are not limited to, reduced late lumen loss, restenosis rate, and target lesion 
revascularization and increased patency. 
 
8.4. Risk-to-Benefit Rationale 
Paclitaxel has been used safely in humans for over 20 years at doses much higher than the 
dose applied to the GORE® DCB Catheter. In addition, paclitaxel-coated balloons have been 
used safely in humans since 2004 with similar doses of paclitaxel as the GORE® DCB 
Catheter. Pre-clinical animal studies of the GORE® DCB Catheter were conducted to 
demonstrate safety and evaluate device performance (See IB for detailed descriptions and 
results of these studies). All devices performed as expected in the porcine models; no 
additional procedural risks were identified. Post mortem examination of the treated arteries 
demonstrated freedom from injury associated with the device. No potential clinical harms 
resulting from treatment with the GORE® DCB Catheter were identified from the animal 
studies. These pre-clinical animal studies support the expectation that the benefits of the 
GORE® DCB Catheter described in section 8.3 outweigh the potential risks described in 
section 8.1. 
In addition, the sponsor has conducted risk management activities for the GORE® DCB 
Catheter according to ISO14971:2012. Risks remaining after the risk control measures have 
been implemented are acceptable and the effectiveness of these measures have been 
verified. The combined impact of the individual risks has been assessed and found to be 
acceptable. The benefit of the product has been assessed against the overall residual risk and 
determined that the medical benefit of the product outweighs the risk. The overall residual risk 
for this product is comparable to similar products. Therefore, overall residual risk has been 
evaluated for the GORE® DCB Catheter and has been deemed acceptable. All appropriate 
methods are in place to collect clinical information during the trial for the GORE® DCB 
Catheter. All risks related to the design, manufacturing and usability of the medical device 
have been reduced as far as possible. 
 
9. 
Adverse Events and Safety Monitoring 
Adverse Events (AEs) are defined per ISO 14155:20112T15
2T, as any untoward medical occurrences, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in a 
subject, user or other persons from the beginning of the Index procedure until the final follow-up 
visit, whether device-related or not. 

 
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[Note 1 This definition includes events related to the investigational medical device or the 
comparator. 
Note 2 This definition includes events related to the procedures involved. 
Note 3 For users or other persons, this definition is restricted to events related to investigational 
medical devices.] 
9.1. Anticipated Adverse Events 
Anticipated AEs are complications that are known to be associated with PAD patients 
undergoing endovascular PTA procedures. See Section 8, Risk Assessment. 
9.1.1. 
Adverse Event Relationship 
Each reported AE will be assessed by the Investigator for its primary suspected 
relationship to the device, procedure, or disease. The CEC / DSMB will review this 
information and provide a final adjudicated relationship. 
Only one primary relationship will be assigned to each reported AE. 
Study Device-related 
The functioning or characteristics of the device caused or contributed to the Adverse 
Event. This includes adverse device effect (ADE), defined as an adverse event 
related to the use of an investigational medical device. 
NOTE 1 This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or 
any malfunction of the investigational medical device. 
NOTE 2 This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device. 
 
Study Procedure-related 
The Index procedure (and not the device) caused or significantly contributed to the 
Adverse Event. 
Disease-related 
The underlying PAD disease progression caused or contributed to the Adverse Event, 
and not the device or procedure. 
Not-related 
An Adverse Event which cannot be attributed to the device, procedure, or PAD 
disease. 
Unknown relationship 
The relationship of the Adverse Event to the device, procedure, or disease cannot be 
determined. 
9.1.2. 
Adverse Event Classification 
Each AE, regardless of the causal relationship with the investigational device, will be 
assessed by the Investigator to determine if it is Serious or Non-serious, as defined 
below. The CEC / DSMB will review this information and provide a final adjudicated 
classification. 
Serious Adverse Event (ISO 14155:2011 Definition2T15
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A Serious Adverse Event is an Adverse Event that 
 
led to death 
 
led to serious deterioration in the health of the subject that either resulted in 
o a life threatening illness or injury, or 
o a permanent impairment of a body structure or body function, or 
o inpatient or prolonged hospitalization, or 
o medical or surgical intervention to prevent life threatening illness or injury or 
permanent impairment to a body structure or a body function 
 
led to fetal distress, fetal death or a congenital abnormality or birth defect. 
Note 1: In the EU, this includes device deficiencies that might have led to an SAE if 
a) suitable action had not been taken or b) intervention had not been made or c) if 
circumstances had been less fortunate. These are handled under the SAE reporting 
system. 
Note 2: For the purposes of this study, inpatient hospitalization includes any 
hospitalization lasting 24 hours or more. Hospitalization without the onset of a new 
adverse event or aggravation of a pre-procedure complication, such as hospitalization 
listed below, will not be handled as serious adverse events and do not have to be 
reported to the sponsor. 
 
Hospitalization planned prior to enrollment in the study  
 
Administrative hospitalization (e.g. hospitalization for a regular medical checkup, 
examination or training) 
 
Hospitalization at a rehabilitation facility 
 
Note 3: In Germany, this includes the Serious Adverse Event (SAE) definition 
according to §2 No. 5 MPSV - A serious adverse event is any undesirable event that 
occurred in the course of a clinical trial or perfomance evaluation requiring approval 
which, directly or indirectly, has led, might lead or might have led to death or to a 
serious deterioration in the state of health of a subject, or user or other person 
whether or not the event was caused by the investigational medical device. 
 
Serious Adverse Device Effect (SADE) 
A serious adverse device effect is defined as an adverse device effect that has 
resulted in any of the consequences characteristic of a serious adverse event. 
 
Non-serious Adverse Event 
Any AE not meeting the above definition of serious. 
 
9.1.3. 
Adverse Event Reporting and Coding 
AEs will be reported on the appropriate case report form (CRF) and documented in 
the subject’s medical record. The Investigator at each Site is ultimately responsible 
for reporting AEs to the Sponsor. 
The following information on each reported Adverse Event will be collected: 

 
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 
AE description 
 
AE onset date 
 
Date AE was reported to the Sponsor 
 
Timing of the event (during or after the Index procedure) 
 
Relationship 
 
Seriousness 
 
Treatment 
 
Outcome 
 
Resolution Date 
 
Adverse Events will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA). 
AE submission guidelines: 
 
AE reporting begins once the patient is enrolled in the study. All AEs should be 
reported from enrollment through study completion / discontinuation. 
 
Provide a diagnosis if possible. If unable to provide a diagnosis, report the 
symptoms as separate events. AE should be reported using the full name without 
abbreviations or narratives. 
 
AEs with an outcome status of “Ongoing” should be assessed at each follow-up 
evaluation to determine if the event has resolved. AE ongoing at study 
completion / discontinuation should be left as “Ongoing” on the AE case report 
form. 
9.1.4. 
Serious AE reporting 
The following AEs must be reported immediately (without unjustified delay) to the 
Sponsor: 
 
Serious AE (including MAE): all AEs which the Investigator classifies as serious 
and all MAE without regard to the cause or relationship to the device. 
 
Device deficiencies that could have led to a serious adverse device effect. 
 
Study drop-out due to AE: all AEs which lead to the drop-out of a subject from 
continued study participation. 
The site Principal Investigator or designee must immediately report all such AEs to 
the Sponsor by phone, fax or e-mail, as soon as possible, and within 24 hours of 
onset, observation, or first reporting of the occurrence. The initial report should 
include all available information on the event, including a written narrative detailing 
the clinical course of the AE. The information and causal evaluations in the narrative 
must be consistent with the information recorded on the AE CRF. 
Updated AE CRFs and subject narratives must be forwarded when further information 
becomes available. The Investigator must provide a final AE CRF and the subject 
narrative after final assessment of the AE. Source documents must be submitted 
upon request (e.g., histopathology findings, catheter lab reports, etc.). All source 
documents must be blinded using only the subject's unique study identifier and 
forwarded to the Sponsor. 

 
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Additional reporting of adverse advents, serious adverse events, and device 
deficiencies should be conducted according to the local EC and national regulations. 
In Germany, serious adverse events (regardless of causality) including device 
deficiencies that led or could have led to a serious adverse device effect must be 
reported by the Investigator to the Sponsor. The Sponsor must report all SAEs to the 
German regulatory authority (BfArM). If the relationship of the SAE to the study 
device or the study procedures performed as part of the clinical trial cannot be 
excluded reporting must be done immediately (without unjustified delay) by 
completing the “Report form for reporting of serious adverse events (SAE) in clinical 
trials”. If the relationship of the SAE to the study device or study procedures 
performed as part of the clinical trial can be excluded, reporting must be done 
quarterly by completing the MEDDEV 2.7/3 Report table. 
In addition, a quarterly summary evaluation of all SAEs must be submitted to the 
BfArM by completing the forms provided on the BfArM website. Details of this 
quarterly summary evaluation and the general requirements for SAE reporting to the 
BfArM including the forms to be completed may be found on the BfArM website. 
9.1.5. 
Subject Death 
In this study, death is not considered an AE, but rather the outcome of an AE. An AE 
reported as having an outcome of death should match the cause of death on the 
subject’s death certificate. An ongoing AE at the time of death or study withdrawal will 
remain categorized as ongoing. 
Attempts will be made by the Site to obtain death certificate and autopsy reports, 
when possible. 
9.1.6. 
Subject Withdrawal or Discontinuation 
Any ongoing or unresolved AEs at the time of withdrawal or discontinuation will be 
indicated as “ongoing” on the CRF. 
 
9.2. Unanticipated Adverse Device Effects (UADE) 
An unanticipated adverse device effect (UADE) is defined in 21 CFR 812.3(s) as any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem or death was not previously identified in 
nature, severity, degree of incidence or outcome in the IB, investigational plan or protocol. 
UADEs will be handled in accordance with Sections 9.1.1 thru 9.1.6. 
 
9.3. Clinical Events Committee/Data Safety Monitoring Board 
A combined Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB) will 
be established to review and adjudicate all accumulating safety events (including but not 
limited to: relatedness of event, seriousness of event, and endpoint evaluation) and primary 
endpoints on a regular basis and will advise the Sponsor regarding the continuing safety of 
study subjects as well as the continuing validity and scientific merit of the study.  

 
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This committee will operate under pre-specified procedures as outlined in the CEC / DSMB 
Charter in accordance with the FDA’s Guidance for Clinical Trial Sponsors on the 
Establishment and Operation of Clinical Trial Data Monitoring Committees. The CEC / DSMB 
will be responsible for conducting periodic reviews of aggregate data on a prescribed basis. 
The frequency of data review and other roles and responsibilities of the CEC / DSMB will be 
specified in the CEC / DSMB Charter. The CEC / DSMB will also establish stopping rules to 
protect the safety of the study subjects. 
Based on the review of safety data, the CEC / DSMB will make recommendations to the 
Sponsor. Recommendations may include study termination, study continuation with or without 
major or minor modifications, temporary suspension of enrollment and / or study intervention 
until some uncertainty is resolved. All final decisions regarding study modifications rest with 
the Sponsor. 
Termination or modification may be recommended for any perceived safety concern based on 
clinical judgment, including, but not limited to, a higher than anticipated rate for any component 
of the primary safety endpoint, device failures resulting in AEs, or unexpected Serious Adverse 
Events (SAEs). Section 11.8 provides additional detail regarding suspension or termination of 
the study. 
The DCB 15-02 CEC / DSMB will consist of members not participating in the study and who 
are independent from the study Sponsor and experienced in peripheral interventions.  The 
team shall include a biostatistician. The members will be compensated for their involvement in 
the CEC / DSMB, including reimbursement for reasonable travel expenses to attend meetings. 
 
10. Statistical Analysis 
10.1. Study Hypotheses 
34TThe study is designed to show that the 34Tperformance of the GORE® DCB Catheter is superior 
to a performance goal derived from literature reports of uncoated PTA balloons, measured six 
months after intervention.23-29 
The statistical hypothesis is specified as: 
𝐻0: 𝜇𝑇≥ 𝑃𝐺 
𝐻𝐴: 𝜇𝑇<  𝑃𝐺 
UWhere: 
HR0
R: The study’s Null Hypothesis states that the Mean LLL from the GORE® DCB Catheter is 
equal to or greater than the performance goal 
HRA
R: The study’s Alternate Hypothesis states that the Mean LLL from the GORE® DCB Catheter 
is less than the performance goal 
𝜇𝑇 is the mean LLL for the test group(GORE® DCB). 
𝑃𝐺 is the performance goal. 
The performance goal considered for the GORE® DCB Catheter is 0.9 mm. The upper limit of 
the 95% confidence interval for the mean LLL at six months below 0.9 mm in the study would 
meet the requirement of the superiority of the GORE® DCB Catheter to the uncoated PTA. 
 
10.2. Sample Size Assumptions 

 
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Previous DCB studies that were intended to supply clinical data to support CE mark approval 
have used uncoated PTA as a comparator for the test DCB.  Given the prominent role that 
uncoated PTA balloons continue to play in the endovascular management of PAD lesions, 
peer-reviewed published data from uncoated PTA balloons were used as the starting point for 
calculation of a performance goal. 23-29 The clinical studies that supplied data for performance 
goal calculation demonstrate considerable homogeneity and bear many similarities to the 
proposed GORE® DCB Catheter European CE mark pivotal clinical investigation. 
A random effects meta-analysis was performed for these data. This provided a value of 1.2 
mm as an estimate of the mean LLL of uncoated PTA with a standard error of 0.15 mm. The 
resulting 95% confidence interval on the mean was [0.9 mm, 1.5 mm]. 
The lower limit of the 95% confidence interval of the mean LLL at six months i.e., 0.9 mm is 
considered the performance goal for the GORE® DCB Catheter European CE mark pivotal 
clinical investigation. This performance goal ensures that the GORE® DCB Catheter LLL will 
be superior to the uncoated PTA LLL results from the literature. 
 
10.3. Sample Size Determination 
The following assumptions were used to calculate sample size: 
• 
Performance Goal = 0.9 mm 
• 
One-sided Level of significance = 0.025 
• 
Power = 90% 
• 
LLL SD = 0.9 mm (average SD for DCBs across the published DCB studies) 
• 
20% loss to follow-up (average loss to follow-up across the published DCB studies) 
• 
Expected GORE® DCB Catheter six month LLL = 0.44 mm (median DCB LLL from the 
published DCB studies) 
 
Using these assumptions, the calculated sample size is 52 subjects. 
 
10.4. Data Analysis 
10.4.1. Timing of Analyses 
One formal statistical analysis is planned for the European CE mark approval when 
all enrolled subjects would have either completed six month follow-up and the data 
are available or would have completed the study as defined in this protocol. Other 
informal analyses may be performed throughout the course of the study. The final 
analysis will be performed once all subjects will have completed the study. 
 
10.4.2. Analysis Populations 
All subjects enrolled into the study will be part of the ITT population dataset. In 
addition a Per-protocol population dataset will be created and will consist of all 
subjects enrolled into the study who meet all inclusion and exclusion criteria and 
receive treatment as per protocol. 
 

 
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10.4.3. Pooling of Data 
All the sites in the study will follow the same protocol, receive the same training and 
will be monitored for adherence to the study plan and regulations, the data collection 
and handling procedures and guidelines will also be same for all sites. Therefore the 
data from all sites will be pooled and analyzed. 
 
10.4.4. Statistical Analysis of Primary Endpoint(s) 
The 95% confidence interval for the estimated mean LLL at six months will be 
constructed using a normal distribution. The upper limit of the confidence interval 
below the performance goal of 0.9 mm will lead to reject the null hypothesis. The one 
sided p-Value will be obtained using the test for the equality of mean to the 
performance goal and will provide consistent decision if the p-Value is less than 
0.025. 
No formal performance goal is specified for the Safety Endpoint. The presentation will 
include frequency and the percentage of the composite MAEs along with its 
components i.e., Death, CD-TVR and Major Amputation occurring within 30 days of 
the initial procedure.  
Any deviation(s) occurring from the original statistical plan during the course of this 
study will be documented in the Sponsors Statistical Analysis Plan. 
 
10.4.5. Statistical Analysis of Secondary Endpoint(s) 
No formal performance goals are specified for the secondary endpoints. The numeric 
endpoints will be analyzed using mean and standard deviations whereas qualitative 
or categorical endpoints will be presented using frequencies and percentages with 
confidence intervals as appropriate. Kaplan Meier estimates will be calculated for the 
endpoints involving time to event. 
 
10.4.6. Subgroup Analysis 
In addition to the overall analysis, the LLL will also be presented by Age and Gender. 
Subject numbers are insufficient to test clinically meaningful variation in performance 
among sub-groups. Therefore, no hypothesis is specified for such analysis. 
 
11. Ethical and Regulatory Considerations 
11.1. Statement of Compliance 
The study will be conducted in compliance with this protocol, International Conference on 
Harmonization Good Clinical Practice E6 (ICH-GCP) – as applicable, ISO 14155:2011, and 
other applicable regulatory requirements. 
 
The following are applicable to this study: 
21 CFR Part 11 
Electronic Records; Electronic Signatures 
21 CFR Part 50 
Protection of Human Subjects 

 
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21 CFR Part 54 
Financial Disclosure By Clinical 
Investigators 
21 CFR Part 56 
Institutional Review Boards 
21 CFR Part 812 
Investigational Device Exemptions 
ICH-GCP E6 
International Conference on 
Harmonization Regulations Guideline For 
Good Clinical Practice 
Amendment to the MDD 
(2007/47/EC) 
Article 15 Annex X 
Directive 2007/47/EC of the European 
Parliament and of the Council of 5 
September 2007 
ISO 14155:2011 (E) 
Clinical investigation of medical devices 
for human subjects – Good clinical 
practice 
MPG 
The Act on Medical Devices 
(Medizinproduktegesetz – MPG) in its 
currently effective version 
MPKV 
Ordinance on Clinical Investigations with 
Medical Devices (Verordnung über 
klinische Prüfungen von Medizinprodukten 
(MPKPV) in its currently effective version 
MPSV 
Ordinance on the Central Collection, 
Analysis and Prevention of Risks Arising 
from the Use of Medical Devices / Safety 
Plan for Medical Devices (Verordnung 
über die Erfassung, Bewertung und 
Abwehr von Risiken bei 
Medizinprodukten) in its currently effective 
version 
  
11.2. Compliance Responsibilities 
The Sponsor will conduct the study in accordance with all applicable regulations and laws, any 
relevant agreements, the study protocol, and all approval conditions of the reviewing EC and 
German competent authority. Any additional requirements imposed by the EC or regulatory 
authority shall be followed. The Sponsor will be responsible for documenting that Investigators 
have the necessary skills, training and information to properly conduct the study. The Sponsor 
will confirm proper monitoring of the study and is responsible for obtaining EC and BfArM 
approval prior to enrollment. The clinical investigation shall not begin until the Sponsor has 
confirmed the required approval / favorable opinion from the EC or regulatory authority have 
been obtained.  The Sponsor will provide information to the Investigators, the reviewing EC 
and German competent authority concerning the progress of and any new material information 
about the study. 

 
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The Investigator will conduct the study in accordance with all applicable regulations and laws, 
any relevant agreements, the study protocol, and all approval conditions of the reviewing EC 
and German competent authority. Any additional requirements imposed by the EC or 
regulatory authority shall be followed. The Investigator will verify EC approval is obtained prior 
to enrollment, maintained throughout the course of the study, and that all EC reporting 
requirements are met, if required per national regulations. The Investigator is responsible for 
protecting the rights, safety, and welfare of subjects under the Investigator’s care and for the 
control of devices under investigation. The Investigator is also responsible for ensuring that 
informed consent is properly obtained. 
The Sponsor will obtain clinical trials insurance as required by the laws of each country in 
which the study is conducted. 
The study shall be conducted in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki. 
 
11.3. Informed Consent 
The Investigator shall verify that all potential subjects for this study are provided with a consent 
form describing this study and sufficient information to make an informed decision about their 
participation. 
The formal consent of a subject, using the EC-approved consent form, must be obtained by 
the Investigator before that subject undergoes any study-related procedure. The consent form 
will be signed and personally dated by the subject and the person who conducted the informed 
consent discussion. The original signed informed consent form will be retained in the subject 
records. A copy of the informed consent document will be given to the subject for his or her 
records. Any significant, new information which emerges while the study is in progress that 
may influence a subject’s willingness to continue to take part in the study will be provided to 
the subject. 
The Investigator shall verify that documentation of the acquisition of informed consent is 
recorded in each subject’s records in accordance with applicable regulations. 
Emergency contact details for reporting serious adverse events and serious adverse device 
effects will be listed in the EC-approved Informed Consent Form. 
 
11.4. Independent Ethical Review 
The Investigator shall not enroll any subjects prior to obtaining approval for the study from a 
properly constituted independent EC. 
The Sponsor will submit the protocol, protocol amendments, informed consent forms, other 
information to be provided to subjects such as survey instruments or questionnaires, and any 
proposed advertising / recruitment materials, to the EC for written approval. 
 
11.5. Conflict of Interest 
All Investigators will follow applicable laws and regulations as well as the conflict of interest 
policies of their Site and the reviewing EC. 
 

 
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11.6. Emergency / Compassionate Use 
No emergency or compassionate use of GORE® DCB Catheter will be allowed. 
 
11.7. Confidentiality 
All subject records will be kept confidential to the extent provided by applicable laws and 
regulations. The study monitors and other authorized representatives of the Sponsor may 
inspect all documents and records required to be maintained by the Investigator, including but 
not limited to medical records. 
The Investigator will inform the subjects that their records will be reviewed. 
De-identified data generated by this study may also be reviewed by the Site’s EC and other 
regulatory bodies, [e.g., FDA, BfArM, MPA Sweden, BSI, PMDA]. 
 
11.8. Study Discontinuation or Suspension 
The entire study may be suspended or prematurely terminated by the Sponsor in the following 
cases: 
 
Serious adverse events as defined in section 9.1.2 attributable to the investigation.  
 
If new data become available which raises concern about the safety of the GORE® 
DCB Catheter, so that continuation of the study might cause unacceptable risks to the 
subjects. 
 
If suspicion of an unacceptable risk to subjects arises during the clinical investigation, 
the Sponsor may suspend the clinical investigation while the risk is assessed. The 
Sponsor will terminate the clinical investigation if an unacceptable risk is confirmed. 
 
National regulatory authority withdrawal of study approval. 
 
On recommendation by the CEC / DSMB for any perceived safety concern based on 
clinical judgment, including, but not limited to, a higher than anticipated rate for any 
component of the safety endpoint, device failures resulting in AEs or unexpected 
SAEs. 
 
Study participation of an individual study site or an individual member of a study site may be 
suspended or prematurely terminated by the Sponsor in the following cases: 
 
If a principal investigator, EC or regulatory authority responsible for the study has 
withdrawn approval for any reason. 
 
If Sponsor monitoring or auditing identifies serious or repeated deviations on the part of 
the study site or an individual study investigator. 
 
Procedures for suspension or premature termination of this study are: 
 
If the Sponsor, EC or regulatory authority suspends or prematurely terminates the 
study, all enrolled subjects shall continue to be followed and treated as per standard of 
care at each site. The Sponsor may request that subjects are contacted or complete an 
office visit prior to study termination.  

 
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 
The Investigator or each site or authorized designee shall promptly inform the enrolled 
subjects. 
 
If the Sponsor received notice that the EC and / or regulatory authority approval has 
been withdrawn for any reason, the Sponsor shall notify the Investigator as soon as 
possible and preferably within 24 hours. Study enrollment must immediately cease until 
such approval is reinstated. 
 
If the Investigator receives notice that the EC and / or regulatory authority approval has 
been withdrawn for any reason, the Investigator shall notify the Sponsor as soon as 
possible and preferable within 24 hours. Study enrollment must immediately cease until 
such approval is reinstated. 
 
If the Sponsor suspends or prematurely discontinues the study the Sponsor shall 
inform the investigators, the ECs and the authority of the rational and provide them with 
the relevant data supporting this decision.  
 
If the study (or a study site) is prematurely terminated a routine close out visit as 
described in Section 6.2 will be performed. 
 
The procedures of premature study termination of an individual patient (voluntary withdrawal 
or withdrawal of the patient by the investigator) are detailed in section 5.9 and 5.11 of the 
study protocol.  
 
Procedure for resuming the clinical investigation after temporary suspension 
 
When the Sponsor concludes an analysis of the reason(s) for the suspension, 
implements the necessary corrective actions, and decides to lift the temporary 
suspension, the Sponsor shall obtain concurrence from the ECs and, where 
appropriate, the regulatory authority by providing the rational and relevant data 
supporting this decision before the clinical investigation resumes. 
 
When concurrence from ECs and, where appropriate, other regulatory authorities is 
obtained, the Sponsor shall inform the investigators to resume the clinical investigation. 
 
If subjects have been informed of the suspension, the principal investigator or 
authorized designee shall inform them of the reasons for resumption. 
 
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