Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) After Sub-optimal Percutaneous Transluminal Angioplasty (PTA) or Atherectomy: REACTIVATE I

Study Overview
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Brief Summary
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Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) after Sub-optimal percutaneous transluminal angioplasty (PTA) or Atherectomy: REACTIVATE I

Official Title
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Feasibility Study of the Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Popliteal Artery (PA) After Sub-optimal Percutaneous Transluminal Angioplasty (PTA) or Atherectomy: REACTIVATE I

Conditions
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PAD - Peripheral Arterial Disease

Intervention / Treatment
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* Combination Product: Vessel Restoration System (VRS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects for this study must meet all of the following general eligibility criteria AND the answer must be YES to all general inclusion criteria: Subject (or Legal Guardian) is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits. Male or female subject of at least 18 years of age. Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4. Has screen failed from the ACTIVATE II study due to the presence of Grade C or D dissection(s). Exclusion Criteria: Life expectancy, documented in the Investigator's opinion, of less than 1 year. Cerebrovascular accident (CVA) or transient ischemic attack (TIA) or cardiac event (e.g., PCI for STEMI/NSTEMI, unstable angina) within 6 months prior to the index procedure. Chronic renal insufficiency with serum creatinine ≥ 2.5 mg/dL or eGFR <45 ml/min within 30 days prior to the index procedure or treatment with peritoneal or hemodialysis. Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3 within 30 days prior to the index procedure or has a history of bleeding diathesis. Receiving oral or intravenous immunosuppressive therapy. Subject has white blood cell (WBC) count < 3.0 (3,000 cells/mm3) within 30 days prior to the index procedure. History of major amputation in the target limb. Any major intervention planned at the index procedure or within 30 days post-index procedure including treatment of contralateral limb. Subject is pregnant, breastfeeding, or planning to become pregnant in the next 30 days. Subjects (male and female) of childbearing potential must agree to use effective birth control measures for 30 days after the index procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This study is a prospective, nonrandomized, multicenter, open-label feasibility study of the VRS for the treatment of atherosclerotic de novo or restenotic lesions in the SFA and/or PA after sub-optimal PTA or atherectomy angiographic outcomes.
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Combination Product: Vessel Restoration System (VRS)|The VRS includes the following components: VRS 10-8-10 Dimer Coated Balloon Catheter VRS Light Fiber VRS Light Source The VRS will collectively refer to all the components used to perform the procedure. Their specific product name will identify individual elements.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An acute reduction in arterial dissections | Reduction in arterial dissection(s) of at least one grade. | 12 months | 
| Primary Patency as assessed by Doppler Ultrasound (DUS) and freedom from CD-TLR at 1 Year | Primary Patency as assessed by Doppler Ultrasound (DUS) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success | Technical success is defined by successful delivery of the VRS | 12 months | 
| Procedural Success | Procedural Success is defined as an acute reduction in arterial dissection(s) | 12 months | 
| Clinical Success | Clinical success is defined as freedom from CD-TLR | 36 months | 
| Safety Measure | Frequency of MAEs | 72 months | 
| Hemodynamic Improvement | Rate of hemodynamic improvement ABI | 36 months | 
| Rutherford Classification | As assessed by changes in Rutherford Class | 36 months | 
| Quality of Life Measure | Quality of life (QOL) assessment by EQ-5D | 72 months |