Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries
Phase: NA
Conditions: Peripheral Arterial Disease, Lower Extremity Arterial Disease
Sponsor: Baylor Research Institute

  
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March 10, 2026, Version 1.6 
 
 
STUDY TITLE: 
“Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb Arteries” 
STUDY NICKNAME: INVIGOR 
 
Protocol IRB #: 025-412 
National Clinical Trial #: NCT07353905 
 
 
PROTOCOL HISTORY 
 
Date: 
July 20, 2025; Version 1.0 
 
Amendment #1: 
 
August 28, 2025; Version 1.1 
Amendment #2: 
September 18, 2025; Version 1.2 
Amendment #3: 
Amendment #4: 
October 31, 2025; Version 1.3 
January 16, 2026; Version 1.4 
Amendment #5: 
Amendment #6: 
February 02, 2026; Version 1.5 
March 10, 2026; Version 1.6 
 
Principal Investigator: 
Subhash Banerjee, MD 
 
 
 
 
Co-Principal Investigator: 
Anand Gupta, MBBS, MPH;  
Zachary Rosol, MD;  
Sameh Sayfo, MD 
John Eidt, MD 
 
 
 
 
 
 
Statistician: 
Anand Gupta, MBBS, MPH 
 
 
 
 
 
 
Data Management: 
TBD 
 
 
 
 
 
 
 
 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
025-412  
 
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March 10, 2026, Version 1.6 
 
PROTOCOL SIGNATURE PAGE 
Study Title:  Intravascular Ultrasound Imaging Guidance for Optimal Revascularization of Limb 
Arteries 
 
Protocol Number: V1.6 
 
IRB Number: 025-412  
 
I have read this protocol and agree to adhere to the requirements outlined within. I will provide 
copies of this protocol and all pertinent information to the study personnel under my 
supervision. I will review and discuss this material with them and ensure they are fully informed 
regarding the requirements of this protocol. I will also ensure that this study is conducted in 
compliance with this protocol, Good Clinical Practice (GCP), and all applicable regulatory 
agencies and their requirements. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator (Printed Name) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Principal Investigator (Signature) 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
025-412  
 
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ABBREVIATIONS 
Abbreviation 
Term 
AE  
Adverse Event  
CLIA  
Clinical Laboratory Improvement Amendments  
CLTI 
Chronic limb threatening ischemia 
CNS  
Central Nervous System  
CRF  
Case Report Form  
CTCAE  
Common Terminology Criteria for Adverse Events  
LE 
Lower Extremity 
GCP  
Good Clinical Practice  
ICH  
International Conference on Harmonization  
IRB  
Institutional Review Board  
IVUS 
Intravascular ultrasound 
PAD 
Peripheral arterial disease 
PI  
Principal Investigator  
RCT 
Randomized controlled trial 
SAE  
Serious Adverse Event  
TLR 
Target lesion revascularization 
 
 
 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
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Table of Contents 
PROTOCOL SIGNATURE PAGE ............................................................................................................ 2 
ABBREVIATIONS .................................................................................................................................... 3 
STUDY TEAM CONTACT INFORMATION .............................................................................................. 8 
1. 
STUDY OBJECTIVES .................................................................................................................... 9 
1.1 
OBJECTIVES ....................................................................................................................................... 9 
1.1.1 
Primary Objective ............................................................................................................................. 9 
1.1.2 
Secondary Objective ......................................................................................................................... 9 
1.2 
ENDPOINTS ..................................................................................................................................... 9 
1.2.1 
Primary Endpoint .............................................................................................................................. 9 
1.2.2 
Secondary and Exploratory Endpoints .............................................................................................. 9 
2. 
HYPOTHESIS ................................................................................................................................. 9 
3. 
BACKGROUND .............................................................................................................................. 9 
4. 
STUDY DESIGN ............................................................................................................................. 10 
4.1. DESCRIPTION OF STUDY DESIGN .............................................................................................. 10 
5. 
SELECTION OF PARTICIPANTS AND ENROLLMENT GOALS ................................................. 11 
5.1. INCLUSION/EXCLUSION CRITERIA ............................................................................................ 11 
5.1.1. INCLUSION CRITERIA ................................................................................................................... 11 
5.1.2. EXCLUSION CRITERIA ................................................................................................................. 12 
6. 
STUDY PROCEDURES .................................................................................................................. 12 
6.1. SCREENING/BASELINE VISIT ...................................................................................................... 12 
6.2. ENROLLMENT ............................................................................................................................... 12 
6.2.1. RANDOMIZATION .......................................................................................................................... 12 
6.2.2. PROCEDURE ................................................................................................................................. 13 
LOWER EXTREMITY ENDOVASCULAR INTERVENTION PER STANDARD OF CARE ........................................ 13 
INTRAVASCULAR ULTRASOUND (IVUS) GUIDED ENDOVASCULAR INTERVENTION PER CLINICAL TRIAL ......... 13 
ANGIOGRAPHY GUIDED ENDOVASCULAR INTERVENTION PER STANDARD OF CARE ......................................... 13 
6.2.3. PRE/POST-PROCEDURE AND DATA COLLECTION ................................................................. 14 
IF THE INDEX PROCEDURE IS CONSIDERED A TECHNICAL FAILURE (>30% RESIDUAL 
STENOSIS IN THE TARGET LESION), THE 6-MONTH FOLLOW-UP DATA ON THE DUPLEX 
ULTRASOUND WILL NOT BE COLLECTED AS THE VESSEL IS KNOWN TO NOT BE PATENT. ... 14 
6.2.4 CORE LABORATORY IMAGING ................................................................................................... 14 
7. 
UNKNOWN AND POTENTIAL RISKS AND BENEFITS TO PARTICIPANTS ............................. 14 
7.1. RISKS ASSOCIATED WITH LOWER EXTREMITY ENDOVASCULAR INTERVENTION 
PROCEDURES ......................................................................................................................................... 14 
7.1.1. VASCULAR ACCESS RISK ........................................................................................................... 14 
7.1.2. INTERNET-BASED DATA COLLECTION ..................................................................................... 15 
7.2. POTENTIAL BENEFITS ................................................................................................................. 15 
7.4 OVERALL RISK BENEFIT RATIO ..................................................................................................... 15 
8. 
CRITERIA FOR PARTICIPANT AND STUDY COMPLETION AND PREMATURE STUDY 
TERMINATION ......................................................................................................................................... 15 
8.1. PARTICIPANT COMPLETION ....................................................................................................... 15 
8.2. PARTICIPANT WITHDRAWAL CRITERIA .................................................................................... 16 
9. 
SAFETY MONITORING AND REPORTING .................................................................................. 16 
9.1. OVERVIEW ..................................................................................................................................... 16 
9.2. DEFINITIONS .................................................................................................................................. 16 
9.2.1. ADVERSE EVENT (AE) .................................................................................................................. 16 
9.2.2. SERIOUS ADVERSE EVENT (SAE) .............................................................................................. 17 
9.3. GRADING AND ATTRIBUTION OF ADVERSE EVENTS ............................................................. 17 
9.3.1. GRADING CRITERIA ..................................................................................................................... 17 
9.3.2. ATTRIBUTION DEFINITIONS ........................................................................................................ 18 
9.4. COLLECTION AND RECORDING OF ADVERSE EVENTS ......................................................... 18 
9.4.1. COLLECTION PERIOD .................................................................................................................. 18 
9.4.2. COLLECTING ADVERSE EVENTS ............................................................................................... 18 
9.4.3. RECORDING ADVERSE EVENTS ................................................................................................ 19 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
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9.5. REPORTING OF SERIOUS ADVERSE EVENTS AND ADVERSE EVENTS ............................... 19 
9.5.1. REPORTING OF SERIOUS ADVERSE EVENTS TO SPONSOR ................................................. 19 
9.5.2. REPORTING OF ADVERSE EVENTS TO IRB .............................................................................. 20 
9.6. SAFETY MONITORING REVIEW .................................................................................................. 20 
9.6.1 DSMB ................................................................................................................................................... 20 
10. 
STATISTICAL CONSIDERATIONS AND ANALYTICAL PLAN ................................................... 20 
11. 
ETHICAL CONSIDERATIONS AND COMPLIANCE WITH GOOD CLINICAL PRACTICE. ........ 21 
11.1. STATEMENT OF COMPLIANCE ................................................................................................... 21 
11.2. INFORMED CONSENT PROCESS ................................................................................................ 21 
11.3. PRIVACY AND CONFIDENTIALITY .............................................................................................. 22 
11.4.1 Crossover Policy .................................................................................................................................... 22 
11.4 2 Statistical Handling of Crossover ........................................................................................................... 22 
11.4.3 Justify Crossover in DSMB and IRB Reporting ..................................................................................... 23 
12 
REFERENCES ................................................................................................................................ 24 
13 
APPENDIX A. SCHEDULE OF EVENTS ....................................................................................... 25 
 
 
 
ERROR! BOOKMARK NOT DEFINED. 
 
 
 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
025-412  
 
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SYNOPSIS 
Title 
Intravascular Ultrasound Imaging Guidance for Optimal 
Revascularization of Limb Arteries 
Short Title  
INVIGOR 
Study Objectives 
 
Primary Objective:  
To compare the primary patency rates at 6 months between 
IVUS-guided and non-IVUS-guided LE endovascular 
interventions. 
Secondary Objective:  
1. To evaluate differences in procedural and technical 
successes rates. 
2. To assess the impact of IVUS on clinical outcomes, including 
target lesion revascularization (TLR), amputation-free 
survival, and functional improvement. 
3. To analyze cost-effectiveness by comparing procedural 
costs, complications, and reintervention rates between the 
two groups. 
 
Study Outcomes and 
Endpoints 
Primary Endpoint:  
Primary patency at 6 months (defined as freedom from 
restenosis ≥50%, or an increase in peak systolic velocity ≥2.5 
times reference proximal segment or TLR) 
Secondary Endpoints:  
Procedural success, clinically driven-TLR (CD-TLR), amputation-
free survival, functional status improvement Rutherford class 
improvement), and cost-effectiveness, all evaluated at 12 
months. 
 
Study Design 
Prospective multicenter randomized controlled trial 
 
 
Accrual Objective 
 
Enrollment goal N=350 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
025-412  
 
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Study Duration 
 3 years (36 months) 
Recipient Inclusion 
Criteria 
o Age ≥18 years 
o Symptomatic LE PAD - Rutherford Class 2-5  
o Angiographic evidence of >50% stenosis 
o Undergoing LE peripheral artery intervention  
o Target lesion is iliac, femoropopliteal, profunda or 
supramalleolar below-the-knee arteries (target 
lesions extending into the abdominal aorta and 
inframalleolar BTK may be included). 
Recipient Exclusion 
Criteria 
o Prior intervention at the target lesion within 6 
months 
o Target lesion is abdominal aorta or inframalleolar 
BTK arteries. 
Sponsor: 
Baylor Scott and White Research Institute 
Principal 
Investigator: 
Subhash Banerjee, MD 
Co-Investigators: 
Anand Gupta, MBBS, MPH;  
Zachary Rosol, MD;  
Sameh Sayfo, MD 
John Eidt, MD 
Study Sites: 
Baylor Scott & White Health (BSWH) system/ Baylor University 
Medical Center (BUMC):  
• 
Patients will be recruited from up to 10 Baylor Scott & 
White Health System (BSW) sites in Texas 
• 
Potential Non-BUMC/BSWH sites to be added such as Ballad 
Health (Wellmont), Cleveland Clinic, Oklahoma Heart, and 
Ascension Seton  
Study Site Locations: 
Coordinating Center: The Heart Hospital Dallas 
Funding 
• 
Baylor Scott & White Research Institute:  
Cardiovascular Research Review Committee (CVRRC) 
funding will be used as seed money for study start up, 
training of sites, and initial patient enrollment.  
• 
Grant funding by Philips Inc. 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
025-412  
 
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Principal investigator  • 
Subhash Banerjee, MD & Baylor Scott & White Research 
Institute. 
Medication and 
Doses: 
NA 
Devices: 
NA 
Procedures: 
Per standard of care, non-investigational procedure. 
1:1 Randomization to either of the below 2 groups: 
• 
IVUS group: Pre-and post-procedural IVUS to guide 
atherectomy, balloon angioplasty-based treatments and/or 
stent placement 
• 
Control group: Standard angiography-guided intervention 
without IVUS 
Data collection 
source 
• 
EPIC chart reviews 
• 
Catheterization laboratory cloud-based imaging archival 
system  
• 
XL PAD registry (BSWRI IRB # 017-114) 
• 
Subject questionnaires 
• 
Data from external sites- TBD 
Efficacy 
Assessments: 
 Based on primary and secondary endpoints. 
Safety Assessments: 
 Procedural safety and device related safety parameters. 
 
STUDY TEAM CONTACT INFORMATION 
 
Name 
Contact Information 
Role on Study 
Subhash Banerjee, MD 
Subhash.Banerjee@BSWHealth.org 
PI 
Zachary Rosol, MD 
Zachary.Rosol@BSWHealth.org 
Sub-Investigator 
Sameh Sayfo, MD 
Sameh.Sayfo@BSWHealth.org 
Sub-Investigator 
John Eidt, MD 
John.Eidt@BSWHealth.org 
Sub-Investigator 
Anand Gupta MBBS MPH 
Anand.Gupta@BSWHealth.org 
 
Sub-investigator; 
Statistician 
Sarah Weideman 
 
Clinical Study Coordinator 
 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
025-412  
 
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1. STUDY OBJECTIVES 
1.1 OBJECTIVES 
1.1.1 Primary Objective 
To compare the primary patency rates at 6 months between IVUS-guided and non-IVUS-guided 
LE endovascular interventions. 
1.1.2 Secondary Objective 
1. To evaluate differences in procedural and technical successes rates. 
2. To assess the impact of IVUS on clinical outcomes, including target lesion 
revascularization (TLR), amputation-free survival, and functional improvement. 
3. To analyze cost-effectiveness by comparing procedural costs, complications, and 
reintervention rates between the two groups. 
1.2 ENDPOINTS 
1.2.1 Primary Endpoint 
Primary patency at 6 months (defined as freedom from restenosis ≥50% or an increase in peak 
systolic velocity ≥2.5 times reference proximal segment or TLR) 
1.2.2 Secondary and Exploratory Endpoints 
The secondary outcomes evaluated at 12 months include:  
1. Procedural success 
2. Clinically driven-TLR (CD-TLR) 
3. Amputation-free survival 
4. Functional status improvement (Vascular Quality of Life Questionnaire 
(VascuQoL-6), Rutherford class improvement)  
5. Cost-effectiveness 
2. HYPOTHESIS 
The use of IVUS during LE PAD endovascular intervention improves procedural outcomes, 
reduces restenosis rates, and enhances major adverse limb event free survival compared to 
standard angiography-guided intervention without IVUS. 
3. BACKGROUND 
Lower extremity (LE) peripheral arterial disease (PAD)  is a major cause of morbidity, secondary 
to lifestyle limiting claudication, chronic limb threatening ischemia (CLTI), and increased risk of 
cardiovascular events. Endovascular intervention is the preferred treatment for symptomatic LE 
PAD, yet restenosis and suboptimal deployment of non-stent and stent-based treatments 
remain significant challenges. Intravascular ultrasound (IVUS) has emerged as a promising tool 
for optimizing endovascular therapy by providing real-time, high-resolution imaging of vessel 
morphology, plaque burden, and atherectomy, balloon and stent optimization.1, 2  

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
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Our group as the coordinating center for the XLPAD registry (BSWRI IRB 017-114), a multicenter 
U.S. CMS approved quality registry has established the core laboratory reproducibility of IVUS 
imaging in lower extremity arteries.3  
However, its routine use remains debated due to procedural costs and lack of definitive 
randomized controlled trial (RCT) evidence supporting improved long-term outcomes.4-6 
Currently, IVUS is used in <5% of cases in the U.S.7, 8 
4. STUDY DESIGN 
4.1. DESCRIPTION OF STUDY DESIGN 
This is a prospective multicenter randomized controlled trial to evaluate the safety and clinical 
outcomes of Intravascular ultrasound (IVUS) guided lower extremity (LE) arterial endovascular 
intervention involving the iliac, femoropopliteal, profunda and supramalleolar below-the-knee 
arteries in patients with symptomatic peripheral artery disease (PAD) (Rutherford class 2-5). 
(Figure 1) 
 
Figure 1 
• 
Randomization: 1:1 allocation to IVUS-guided versus standard angiography-guided 
intervention 
• 
Intervention: 
o IVUS group: pre-and post-procedural IVUS to guide atherectomy, balloon 
angioplasty-based treatments and/or stent placement 
o Control group: Standard angiography-guided intervention without IVUS 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
025-412  
 
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• 
Endpoints: 
o Primary Endpoint: Primary patency at 6 months (defined as freedom from 
restenosis ≥50% or an increase in peak systolic velocity ≥2.5 times reference 
proximal segment or TLR) 
o Secondary Endpoints: Procedural success, clinically driven-TLR (CD-TLR), 
amputation-free survival, functional status improvement (Vascular Quality of Life 
Questionnaire (VascuQoL-6), Rutherford class improvement), and cost-effectiveness, 
all evaluated at 12 months. 
o Exploratory Endpoints: Walking Impairment Questionnaire (WIQ) at 12 months 
• 
Recruitment: 24 months (Up to 10 BSW and 1-4 external sites). 
• 
Follow-up: Clinical and duplex ultrasound follow-up at 6 months post-intervention (duplex 
ultrasound would not be necessary in the event that a CT Scan or repeat revascularization at 
the target lesion is performed within ±30 days of the 6-month follow-up date). 
• 
Study duration: 36 months 
• 
Data Collection tool: BSWH REDCap 
• 
Procedure insurance coverage: the Angiography guided LE revascularization procedure will 
be per SoC, covered by the subject’s insurance.  
• 
The IVUS guided LE revascularization procedure will also be billed to subject insurance.   
5. SELECTION OF PARTICIPANTS AND ENROLLMENT GOALS 
Patients will be recruited from up to 10 Baylor Scott & White Health System (BSW) sites in 
Texas, integrated using 
• 
a unified EMR  
• 
catheterization laboratory cloud-based imaging archival system  
• 
centralized data collection on ongoing basis through the XLPAD registry participation 
Enrollment goals: 
Study wide enrollment goal: 350 
BSWH Sites (first phase of initiation): Dallas, Plano, McKinney, Waxahachie, Ft Worth, Temple.  
No one site should enroll more than 60% of subjects. 
External site enrollment goal: TBD 
Enrollment period: 24 months 
5.1. INCLUSION/EXCLUSION CRITERIA 
5.1.1. INCLUSION CRITERIA  
1. Age ≥18 years 
2. Symptomatic LE PAD - Rutherford Class 2-5  
3. Angiographic evidence of >50% stenosis 
4. Undergoing LE peripheral artery intervention 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
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5.  Target lesion is iliac, femoropopliteal, profunda or supramalleolar below-the-knee 
arteries (target lesions extending into the abdominal aorta and inframalleolar BTK 
may be included). 
5.1.2. EXCLUSION CRITERIA  
Individuals who meet the below criteria are not eligible for enrollment as study participants: 
1. Prior intervention at the target lesion within 6 months 
2. Target lesion is abdominal aorta or inframalleolar BTKStudy Procedures 
5.2. SCREENING/BASELINE VISIT  
Centers will identify potential study participants with symptomatic PAD (Rutherford class 2-5) 
undergoing LE endovascular intervention being evaluated for atherectomy, balloon angioplasty-
based treatments and/or stent placement. 
The research study will be explained in lay terms to each potential research participant, and the 
potential participant will sign an informed consent form before undergoing any study 
procedures. 
The study personnel will review the participant’s medical records for medical history, record 
the participant’s demographic information, and have the patient complete the VASCUQOL-6 
and WIQ (optional) questionnaire. 
The following procedures, assessments, and laboratory measures will be reviewed via the 
medical record for the baseline screening visit (after consent has been obtained): 
1. Medical chart review for medical and surgical history 
2. Lab reports, scans and other testing reports from medical chart 
3. Other information available from subject medical chart for the study data collection 
5.3. ENROLLMENT  
5.3.1. RANDOMIZATION 
Once a participant has consented, all inclusion criteria are met as determined by the treating 
physician, and the treating physician has confirmed intervention in the target lesion will take 
place during the procedure, they will be assigned a unique participant number and randomized 
to IVUS vs non-IVUS control group. Once randomized, the participant is considered enrolled in 
the study. 
1:1 Randomization will be done via an automated REDCap randomization module integrated 
into the data capture system. If the patient does not meet inclusion criteria intra-procedurally 
and is not randomized, the patient is considered a screen failure. 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
IRB#  
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5.3.2. PROCEDURE  
LOWER EXTREMITY ENDOVASCULAR INTERVENTION PER STANDARD OF CARE 
These interventions will be done per standard of care and include: 
• Balloon angioplasty 
• Stenting 
• Atherectomy 
• Intravascular lithotripsy 
• Drug-coated balloon angioplasty 
• Adjunctive use of embolic protection devices  
• Other FDA approved treatments 
INTRAVASCULAR ULTRASOUND (IVUS) GUIDED ENDOVASCULAR INTERVENTION PER CLINICAL 
TRIAL 
Subjects will be randomized 1:1 to have IVUS guided endovascular intervention versus the usual 
angiography guided endovascular intervention. Intravascular ultrasound (IVUS) is a medical 
imaging technique that uses ultrasound to visualize the inside of blood vessels, typically for 
heart coronary arteries. 
A special catheter with an ultrasound transducer is inserted into a blood vessel, typically 
through a puncture in the groin. The ultrasound probe emits high-frequency sound waves that 
bounce off the vessel wall, creating echoes. A computer converts these echoes into real-time 
images of the vessel's interior. 
Uses of IVUS:  
• Diagnosing heart conditions: Identifying plaque buildup, assessing the severity of 
atherosclerosis, and evaluating the structure of artery walls.  
• Guiding angioplasty and stenting: Helping doctors determine the optimal location and 
size of stents.  
• Evaluating stent placement: Assessing if the stent is properly expanded and if there are 
any complications like in-stent restenosis.  
• Assessing the effectiveness of interventions: Determining if angioplasty or atherectomy 
has been successful. 
ANGIOGRAPHY GUIDED ENDOVASCULAR INTERVENTION PER STANDARD OF CARE 
Angiography is the standard method of care to guide endovascular interventions. Angiography 
is a medical imaging technique used to visualize blood vessels. It involves injecting a contrast 
agent into the blood vessels and using X-rays or other imaging methods to take pictures of the 
vessels. 

PI Name: Subhash Banerjee, MD 
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5.3.3. PRE/POST-PROCEDURE AND DATA COLLECTION 
Data collection for all participants will occur at enrollment through hospital discharge, at 6 
months and 12 months post procedure.  
Phone calls/text messages will be made to study participants by the research team to remind 
them of their clinical follow-up appointments. Patient reported VASCUQOL or other study 
information will be collected via direct patient contact, by phone, text, and emails up to 30 days 
after the follow-up date. This will be included in the patient ICF.  
At each study time point, the study coordinator will collect and enter data into the web-based 
data system (Redcap), including medications of interest, labs, and events of interest, such as 
deaths and adverse events. Data will also be collected from the XL PAD registry (BSWRI IRB 017-
114). 
If the index procedure is considered a technical failure (>30% residual stenosis in the target 
lesion), the 6-month follow-up data on the duplex ultrasound will not be collected as the vessel 
is known to not be patent.  
6.2.4 CORE LABORATORY IMAGING 
Our group has established the core laboratory reproducibility of IVUS imaging in lower 
extremity arteries.3 
All pre- and post-procedural imaging (IVUS and angiography) will be uploaded to the central 
cloud-based imaging archival system and analyzed by the XLPAD Core Laboratory at Baylor 
Scott & White Research Institute. The core lab will not be blinded to treatment group allocation 
and will assess vessel dimensions, plaque burden, stent expansion, and post-procedure luminal 
gain. 
6. UNKNOWN AND POTENTIAL RISKS AND BENEFITS TO PARTICIPANTS 
6.1. RISKS ASSOCIATED WITH LOWER EXTREMITY ENDOVASCULAR INTERVENTION 
PROCEDURES  
6.1.1. VASCULAR ACCESS RISK  
Vascular access during the procedure may cause slight discomfort, pain, bleeding, or bruising at 
the vessel access site. Rarely, fainting, or infection may occur. 
7.1.2. Contrast-Induced Nephropathy Risk 
Contrast agents used during angiography may affect kidney function, particularly in participants 
with preexisting renal insufficiency. 

PI Name: Subhash Banerjee, MD 
Short Title:  INVIGOR 
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7.1.3. Radiation Exposure Risk 
Participants may be exposed to ionizing radiation during angiographic procedures. The amount 
of radiation exposure is generally considered at low risk but may be cumulative over multiple 
procedures. 
7.1.4 Risks of IVUS  
• 
Vessel injury catheter manipulation 
• 
Vessel spasm or thrombosis 
• 
Distal embolization 
• 
Rare allergic reaction to catheter materials or medications used during the procedure 
6.1.2. INTERNET-BASED DATA COLLECTION 
Data from this study will be entered into a computerized database, Redcap. All information will 
be saved and transmitted in the encoded form. Only authorized personnel requiring a password 
will be permitted to enter data. There is a risk, although minimal, of unauthorized persons 
obtaining confidential information. Even though identifying information will be removed, the 
people who get this information may be able to figure out who the subjects are.  The kinds of 
health information that might be given to these people include results from lab tests, 
pathology, or other tests like x-rays.  This information might also include notes and other 
information in the participants’ medical records.   
6.2. POTENTIAL BENEFITS 
For participants in this study, the use of IVUS could improve long-term patency of the lower 
extremity revascularization procedures, reduce the need for reinterventions, and have a better 
patient quality of life. 
 
7.4 OVERALL RISK BENEFIT RATIO 
The potential risks identified are justified by the anticipated benefits that may be afforded to 
subjects undergoing LE endovascular interventions. 
7. CRITERIA FOR PARTICIPANT AND STUDY COMPLETION AND PREMATURE STUDY 
TERMINATION 
7.1. PARTICIPANT COMPLETION 
Participants will have completed the study at the year 1 data collection time point, or once the 
study has been closed. All participants will be actively followed for at least 1 year post 
procedure. 

PI Name: Subhash Banerjee, MD 
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7.2. 
PARTICIPANT WITHDRAWAL CRITERIA 
Participants may be prematurely terminated from the study for the following reasons: 
1. The participant elects to withdraw consent from future study activities, including 
follow-up. 
2. The participant is “lost to follow-up” (i.e., no further follow-up is possible because 
attempts to reestablish contact with the participant have failed). 
3. The participant dies. 
4. The investigator no longer believes participation is in the best interest of the 
participants. 
8. SAFETY MONITORING AND REPORTING 
8.1. 
OVERVIEW 
This section defines the types of safety data that will be collected under this protocol and 
outlines the procedures for appropriately collecting, grading, recording, and reporting those 
data. Appropriate notifications will be made to site principal investigators, Institutional Review 
Boards (IRBs), and health authorities, if applicable. 
Information in this section complies with ICH Guideline E2A: Clinical Safety Data Management: 
Definitions and Standards for Expedited Reporting, ICH Guideline E-6: Guideline for Good 
Clinical Practice, 21CFR Parts 312 and 320, and applies the standards set forth in the Division of 
AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0: 
http://rsc.tech-res.com/safetyandpharmacovigilance/gradingtables.aspx. 
Further details regarding what events will be captured are summarized below. 
8.2. DEFINITIONS 
8.2.1. ADVERSE EVENT (AE) 
Any untoward or unfavorable medical occurrence associated with the participant’s participation 
in the research, whether or not considered related to the participant’s participation in the 
research (modified from the definition of adverse events in the 1996 International Conference 
on Harmonization E-6 Guidelines for Good Clinical Practice) (from OHRP "Guidance on 
Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and 
Adverse Events (1/15/07)" http://www.hhs.gov/ohrp/policy/advevntguid.html#Q2.) 
Adverse events collected for the purpose of this study will be limited to the below: 
1. Myocardial Infarction (MI) 
2. Stroke 
3. Amputation 
4. Bleeding 

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8.2.2. SERIOUS ADVERSE EVENT (SAE) 
Due to the minimal risk nature of this study and the routine nature of the procedures, serious 
adverse events reported for this study are limited in scope. An adverse event or suspected 
adverse reaction is considered “serious” if, in the view of either the investigator or sponsor it is 
an adverse event listed in section 9.2.1 (myocardial infarction, stroke, amputation, or bleeding) 
and results in any of the following outcomes (21 CFR 312.32(a)). 
1. Death. 
2. A life-threatening event: An AE or SAE is considered “life-threatening” if, in the view 
of the investigator its occurrence places the subject at immediate risk of death. It 
does not include an AE or SAE that, had it occurred in a more severe form, might 
have caused death. 
3. Inpatient hospitalization or prolongation of existing hospitalization. 
4. Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions. 
5. Congenital anomaly or birth defect. 
6. Important medical events that may not result in death, be life threatening, or 
require hospitalization may be considered serious when, based upon appropriate 
medical judgment, they may jeopardize the participant and may require medical or 
surgical intervention to prevent one of the outcomes listed above. 
 
The exception is that a death will always be reported as an SAE. 
8.3. GRADING AND ATTRIBUTION OF ADVERSE EVENTS 
8.3.1. GRADING CRITERIA 
The study site will grade the severity of adverse events experienced by the study participants 
according to the criteria set forth in the NIAID/Division of AIDS (DAIDS) Table for Grading the 
Severity of Adult and Pediatric Adverse Events, Version 2.0. This document (referred to herein 
as the DAIDS Grading Table) provides a common language to describe levels of severity, to 
analyze and interpret data, and to articulate the clinical significance of all adverse events.  
For additional information and a printable version of the DAIDS Grading Table, consult the 
DAIDS web site: http://rsc.tech-res.com/safetyandpharmacovigilance/gradingtables.aspx. 
Adverse events will be graded on a scale from 1 to 5 according to the following standards in the 
DAIDS Grading Table: 
Grade 1 = Mild adverse event 
Grade 2 = Moderate adverse event 
Grade 3 = Severe and undesirable adverse event 
Grade 4 = Potentially life-threatening 
Grade 5 = Death 

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Adverse events Grade 3 or higher according to the DAIDS Grading Table that are definitely or 
possibly related to a study procedure or study intervention will be reported. 
8.3.2. ATTRIBUTION DEFINITIONS 
The relationship, or attribution, of an adverse event to the study intervention/procedure will be 
determined by the treating physician (who is a PI or SUB-I on the study) and recorded on the 
appropriate AE case report form. The relationship of an adverse event to the study procedure 
or intervention will be determined using the descriptors and definitions provided in Table 9.3.2. 
 
 
 Table 9.3.2 Attribution of Adverse Events 
Code 
Descriptor 
Relationship (to primary intervention and/or other 
concurrent mandated study therapy or study 
procedure) 
UNRELATED CATEGORY 
1 
Unrelated 
The adverse event is clearly not related: there is 
insufficient evidence to suggest a causal relationship. 
RELATED CATEGORIES 
2 
Possible 
The adverse event has a reasonable possibility to be 
related; there is evidence to suggest a causal 
relationship. 
3 
Definite 
The adverse event is clearly related. 
 
8.4. COLLECTION AND RECORDING OF ADVERSE EVENTS 
8.4.1. COLLECTION PERIOD 
Adverse events will be collected from the time of procedure until a participant completes study 
participation or until 30 days after he/she prematurely withdraws (without withdrawing 
consent) or is withdrawn from the study. 
8.4.2. COLLECTING ADVERSE EVENTS 
Adverse events (including SAEs) may be discovered through any of these methods: 
• Observing the participants. 
• Interviewing the participant [e.g., using a checklist, structured questioning, diary, 
etc.]. 
• Receiving an unsolicited complaint from the participants. 

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• In addition, an abnormal value or result from a clinical or laboratory evaluation 
can also indicate an adverse event, as defined in Section 9.3, Grading and 
Attribution of Adverse Events. 
8.4.3. RECORDING ADVERSE EVENTS 
Throughout the study, the investigator will record adverse events and serious adverse events as 
described above on the appropriate case report form. The investigator must record pertinent 
information including, but not limited to, dates that each adverse event occurred, what 
treatment was prescribed, the outcomes, any follow-up information, and the investigator’s 
opinion of the attribution of the event. All reports should include: 
• Participant ID 
• Site PI 
• Date of the event 
• Last study intervention 
• Description of the event-including intervention(s) 
• Outcome-state if resolved or not; with or without residual sequela; if not completely 
resolved, a follow-up report will be submitted to the coordinating center.  
• Grade of each toxicity 
• Attribution for each toxicity and for each agent 
Once recorded, an AE/SAE will be followed until it resolves with or without sequelae, or until 
the end of study participation, or until 30 days after the participant prematurely withdraws 
(without withdrawing consent) or is withdrawn from the study, whichever occurs first. 
8.5.  REPORTING OF SERIOUS ADVERSE EVENTS AND ADVERSE EVENTS 
8.5.1. REPORTING OF SERIOUS ADVERSE EVENTS TO SPONSOR 
This section describes the responsibilities of the investigator to report serious adverse events to 
the sponsor. Timely reporting of adverse events is required by 21 CFR and ICH E6 guidelines. 
SAE Reporting Guidelines: 
1) All SAEs will be reported to the study PI  
2) Any unanticipated study problem that does not fit the definition of an 
adverse event, but which may, in the opinion of the affiliate site Principal 
Investigator, involve risk to the participant, affect others in the research 
study, or significantly impact the integrity of research data will also be 
reported  
3) Reporting to the local affiliate site IRB will follow local regulations 
and guidelines. 

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8.5.2. REPORTING OF ADVERSE EVENTS TO IRB 
All investigators shall report adverse events in a timely fashion to their local IRBs in accordance 
with applicable regulations and guidelines. 
8.6.  SAFETY MONITORING REVIEW 
9.6.1 DSMB 
The independent data safety monitoring board (DSMB) that is already established for the IRB-
approved XLPAD Registry (#017-114) will serve as the DSMB for this study. The Committee will 
meet once every 6 months, and their recommendations will be disseminated to all participating 
sites. The database will have audits and control checks quarterly throughout the course of the 
study by the Data Safety Committee. The DMSB report will be sent to the IRB within 10 days of 
the quarterly audit.9.6.2 Data coordinating center 
The central coordinating site for the XLPAD registry comprises a core laboratory, REDCap secure 
data collection system, trained personnel, coordinators, biostatistician, study managers and an 
independent data safety monitoring board. The REDCap database for the IRB approved study, 
XLPAD Registry (#017-114) will be used in addition to an INVIGOR REDCap database with a 
randomization module and study specific provisions like the questionnaires. 
9.6.3 Executive Committee (EC) 
The EC that is already established for the IRB-approved XLPAD Registry (#017-114) will serve as 
the EC for this study. 
9. STATISTICAL CONSIDERATIONS AND ANALYTICAL PLAN 
• 
Sample Size Calculation:  
• 
Based on prior studies, we estimated a 12-month primary patency rate of 75% in the IVUS 
group versus 60% in the control group. Also, the study by Ko et al. (2025)6 exhibited a 
primary patency rate of 83.2% in the IVUS - guided group, compared to 69.5% in the 
angiography-guided group, indicating a relative improvement of approximately 13.7%. 
• 
Using a two-sided, two-sample Z-Test with unpooled variance, with a Type I error rate (α) of 
0.05. The control group proportion (P2) is assumed to be 0.695. To detect a proportion 
difference (P1 - P2) of 0.137 (or P1 of 0.832) with 80% power, the number of subjects 
needed will be 148 in Group 1 (treatment) and 148 in Group 2 (control). Anticipating a 15% 
dropout rate, 175 subjects should be enrolled in Group 1, and 175 in Group 2 for a total of 
350 patients, to obtain final group sample sizes of 148 and 148, respectively, and a total 
sample size of 296 patients. The sample size was computed using PASS 2025, version 
25.0.2.9 
• 
Analysis: 
o Kaplan-Meier survival analysis for time-to-event outcomes 
o Cox proportional hazards model for predictors of restenosis and TLR 

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o Cost-effectiveness analysis using quality-adjusted life years (QALYs) and incremental 
cost-effectiveness ratio (ICER) 
o Subgroup analyses based on lesion complexity (TASC classification), stent use, and 
CLTI presentation. 
• 
Study Feasibility analysis: Patients will be recruited from up to 10 Baylor Scott & White 
Health System (BSW) sites in Texas, integrated using a unified EMR and catheterization 
laboratory cloud-based imaging archival system and centralized data collection on an 
ongoing basis through the XLPAD registry participation (BSWRI IRB 017-114). The central 
coordinating site for the registry comprises a core laboratory, REDCap secure data collection 
system, trained personnel, coordinators, biostatistician, study managers, and an 
independent data safety monitoring board.  
• 
Participation of non-BSW sites currently involved in the XLPAD registry (BSWRI IRB 017-
114)  
• 
BSW sites collectively perform approximately 900 peripheral artery interventions per 
year. A site feasibility survey with respect to IVUS (Philips) system availability and 
willingness to participate has been confirmed.  
• 
Core Laboratory: Our group has established the core laboratory reproducibility of IVUS 
imaging in lower extremity arteries.3  
• 
At 60% enrollment, the protocol allows for the provision of an interim analysis to determine 
either termination of the study, or additional patient enrollments beyond the pre specified 
sample with an appropriate statistical penalty if needed. This decision will be made by the 
study executive committee. 
10. ETHICAL CONSIDERATIONS AND COMPLIANCE WITH GOOD CLINICAL PRACTICE. 
10.1. STATEMENT OF COMPLIANCE 
This clinical study will be conducted using good clinical practice (GCP), as delineated in 
Guidance for Industry: E6 Good Clinical Practice Consolidated Guidance, and according to the 
criteria specified in this study protocol.  
10.2. INFORMED CONSENT PROCESS 
The consent process will provide information about the study to a prospective participant and 
will allow adequate time for review and discussion prior to his/her decision. The principal 
investigator or designee listed on the Investigator of Record form (or FDA 1572 if applicable) 
will review the consent and answer questions. The prospective participant will be told that 
being in the study is voluntary and that he or she may withdraw from the study at any time, for 
any reason. All participants (or their legally acceptable representatives) will read, sign, and date 
a consent form before undergoing any study procedures. Consent materials will be presented in 
participants’ primary language. A copy of the signed consent form will be given to the 
participant. 

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The consent process will be ongoing. The consent form will be revised when important new 
safety information is available; the protocol is amended, and/or new information becomes 
available that may affect participation in the study. Study participants will be re-consented if 
new information affecting participant safety is made available. 
The consent process will also be done via a phone call by the study team and the consent form 
emailed via DocuSign Module 11 for signatures. Subject phone number and email will be 
collected for this purpose. 
10.3. PRIVACY AND CONFIDENTIALITY 
A participant’s privacy and confidentiality will be respected throughout the study. Each 
participant will be assigned a unique identification number, and these numbers rather than 
names will be used to collect, store, and report participant information. Site personnel will not 
transmit documents containing personal health identifiers (PHI) to the study sponsor or their 
representatives. 
11.4.1 Crossover Policy 
Crossovers from the angiography-guided (control) arm to IVUS-guided intervention will be 
allowed only in cases of: 
• 
Unanticipated complications during the procedure (e.g., angiographic ambiguity, vessel 
perforation, or dissection requiring further imaging), 
• 
Operator judgment that proceeding without IVUS poses undue patient risk. 
All crossovers must be documented with rationale, timestamped, and reviewed by the 
coordinating center within 48 hours. 
A limit of <10% crossover is anticipated. Exceeding this threshold will prompt review by the 
DSMB. 
11.4 2 Statistical Handling of Crossover 
Use a combination of analytic strategies: 
a. Intention-to-Treat (ITT) Analysis (Primary) 
All patients are analyzed according to their original randomization group, regardless of 
crossover. This maintains randomization and reflects real-world treatment effects. 
b. Per-Protocol (PP) Analysis (Secondary) 
Exclude crossover patients or analyze them in the arms they actually received. This gives insight 
into treatment efficacy when protocol is strictly followed. 

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c. As-Treated Analysis (Exploratory) 
Analyze based on actual treatment received. This may be biased due to loss of randomization 
but helpful for hypothesis generation. 
d. Sensitivity Analyses 
Perform sensitivity analysis using: 
• 
Inverse Probability of Censoring Weighting (IPCW) 
• 
Complier Average Causal Effect (CACE) models 
• 
Instrumental variable methods (using randomization as an instrument) 
The CACE model or Complier Average Causal Effect is a statistical method used in RCTs to 
estimate the true treatment effect among participants who actually comply with their 
assigned treatment—in this case, for those who would have stayed in their assigned 
group (e.g., no IVUS vs IVUS), had there been no crossover. In the INVIGOR trial, if some 
participants cross over from control (no IVUS) to the IVUS arm, standard intention-to-treat 
(ITT) analysis might underestimate the actual effect of IVUS. That’s because ITT keeps them in 
their original group regardless of the treatment they actually received. CACE analysis will 
help isolate the effect of IVUS in those who complied with their assignment—without throwing 
out the randomization benefits. 
To address potential treatment crossovers, we may also conduct Instrumental Variable (IV) 
analyses using randomization as the instrument. A two-stage least squares (2SLS) approach will 
estimate the causal effect of IVUS use on primary and secondary outcomes, including primary 
patency and target lesion revascularization. This IV approach corrects potential noncompliance 
while preserving the randomized design's internal validity. 
The exact methodology would be decided after completion of recruitment. 
11.4.3 Justify Crossover in DSMB and IRB Reporting 
The DSMB will monitor crossover frequency. If crossover exceeds 10% of control arm subjects, 
the trial steering committee may implement protocol reinforcement, investigator retraining, or 
protocol amendment to preserve randomization fidelity. 
 
 
 
 
 

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12 REFERENCES 
1.  Jang JS, Jin HY, Park YA, Yang TH, Seo JS, Kim DK, Wi JH. Meta-Analysis of Intravascular 
Ultrasound-Guided Versus Angiography-Guided Endovascular Treatment in Lower Extremity 
Artery Disease. Am J Cardiol. 2025 Mar 15;239:8-17. 
2. Meng W, Guo J, Pan D, Guo L, Gu Y. Intravascular Ultrasound-Guided Versus Angiography-
Guided Endovascular Therapy for Femoropopliteal Artery Disease: A Scoping Review. J 
Endovasc Ther. 2025 Jun;32(3):627-634. 
3. Soney H, Kakkilaya A, Vazquez DF, Banerjee R, Rosol Z, Tsai S, Banerjee S. Reproducibility of 
Femoropopliteal Artery Intravascular Ultrasound Imaging in Patients With Peripheral Artery 
Disease. Am J Cardiol. 2023 Jul 15;199:1-6. 
4. Allan RB, Puckridge PJ, Spark JI, Delaney CL. The Impact of Intravascular Ultrasound on 
Femoropopliteal Artery Endovascular Interventions: A Randomized Controlled Trial. JACC 
Cardiovasc Interv. 2022 Mar 14;15(5):536-546. 
5. Shin J, Ahn CM, Lee SJ, Lee SH, Lee YJ, Kim BK, Hong MK, Jang Y, Kim TH, Park HW, Jang JY, 
Lee JH, Park JH, Kim SH, Im E, Park SH, Choi D, Ko YG; IVUS‐DCB investigators. Twenty-Four-
Month Outcomes of Intravascular Ultrasound-Guided Drug-Coated Balloon Angioplasty for 
Femoropopliteal Artery Disease. J Am Heart Assoc. 2025 Aug 19;14(16):e041564. 
6. Lee J, Jang JY, Ahn CM, Lee SJ, Lee SH, Lee YJ, Hong SJ, Kim JS, Kim BK, Hong MK, Jang Y, Kim 
TH, Park HW, Lee JH, Park JH, Kim SH, Im E, Park SH, Choi D, Ko YG; IVUS-DCB Investigators. 
Intravascular Ultrasound Predictors of 12-Month Patency Loss Following Drug-Coated 
Balloon Angioplasty for the Femoropopliteal Artery. Am J Cardiol. 2025 Jul 1;246:58-64. 
7. Rymer JA, Secemsky EA. Use of Intravascular Ultrasound to Optimize Peripheral Vascular 
Interventions: How Do We Optimize Outcomes and Improve Uptake? Circ Cardiovasc Interv. 
2023 Apr;16(4):e013016. 
8. Divakaran S, Parikh SA, Hawkins BM, Chen S, Song Y, Banerjee S, Rosenfield K, Secemsky EA. 
Temporal Trends, Practice Variation, and Associated Outcomes With IVUS Use During 
Peripheral Arterial Intervention. JACC Cardiovasc Interv. 2022 Oct 24;15(20):2080-2090 
9. PASS 2025 Power Analysis and Sample Size Software (2025). NCSS, LLC. Kaysville, Utah, USA, 
ncss.com/software/pass. 
 
 

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13 APPENDIX A. SCHEDULE OF EVENTS 
       Study Schedule of events 
Weeks 
Screen 
Randomization/ 
Index 
Procedure 
6 month 
(±30 days) 
12 month 
(±30 days) 
CLINICAL 
 
 
 
 
Eligibility 
Review* 
X 
 
 
 
Medical 
History* 
X 
 
 
 
Surgical 
history* 
X 
 
 
 
Lab / scan 
reports* 
X 
 
 
 
Informed 
Consent 
(remote)** 
X 
 
 
 
VascuQoL- 6 & 
WIQ (WIQ is 
optional) 
X 
 
 
X 
Randomization 
via REDCap 
 
x 
 
 
SoC LE 
intervention 
procedure* 
 
x 
 
 
Core Lab 
analysis  
 
x 
→ 
→ 
Phone 
call/email/text 
reminders by 
research team 
 
 
X 
X 
Clinic visit* 
 
 
x 
x 
Duplex 
ultrasound * 
 
 
x 
 

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Weeks 
Screen 
Randomization/ 
Index 
Procedure 
6 month 
(±30 days) 
12 month 
(±30 days) 
Adverse Event 
Assessment* 
 
x 
→ 
→ 
XL PAD 
Registry data 
(IRB # 017-
114) 
x 
x 
x 
x 
 
*Data collection only 
** Remote consenting via phone call with signatures via DocuSign Module 11.