Feasibility Study of the Vessel Restoration System (VRS): ACTIVATE II

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 Proximal Popliteal Artery (PPA): ACTIVATE II

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 Proximal Popliteal Artery (PPA): ACTIVATE II

Conditions
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PAD - Peripheral Arterial Disease

Intervention / Treatment
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* Other: Vessel Restoration System (VRS)


Participation Criteria
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Eligibility Criteria
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General 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: specific test or procedures are performed and agree to attend all required follow-up visits; Chronic symptomatic lower limb ischemia defined as Rutherford classification 2,3, or 4; General Exclusion Criteria Life expectancy, documented in the Investigator's opinion, of less than 12 months; Cerebrovascular accident (CVA) or transient ischemic attack (TIA) or cardiac event (e.g. PCI for STEMI/NSTEMI, unstable angina) within 3 months prior to enrollment; Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/antiplatelet therapies; Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated; Chronic renal insufficiency with serum creatinine ≥2.5 mg/dL or eGFR <45 ml/min within 30 days of index procedure or treatment with dialysis; Receiving oral or intravenous immunosuppressive therapy; Subject has white blood cell (WBC) count < (3,000 cells/mm3) within 7 days prior to index procedure. Subject has known or suspected active systemic infection evidenced by WBC > 14.0 (14,000/mm3). History of major amputation in the target limb; Any major intervention planned at index procedure or within 30 days post-index procedure including treatment of contralateral limb; Any arterial access other than contralateral femoral artery is required to gain access to target vessel. Ipsilateral access is excluded. Subject is currently on oral anticoagulation therapy, such as warfarin, rivaroxaban, apixaban, or dabigatran etexilate, except when the subject is prescribed such medication as treatment for atrial fibrillation (medication and/or following ablation therapies) Subject is pregnant, breastfeeding, or planning to become pregnant in the next 30 days. Subjects (male and female) of child bearing potential must agree to use effective birth control measures for 30 days after enrollment. Current or planned (within next 365 days) participation in another investigational drug or device clinical trial that has not completed the primary endpoint at the time of randomization/enrollment or that clinically interferes with the current trial endpoints. Any concurrent condition which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol and follow-up visits

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
Intervention Model: Single Group Assignment
Interventional Model Description: NVS Therapy will be delivered to de novo lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) during PTA in patients with symptomatic peripheral artery disease
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alucent VRS for Treatment of Atherosclerotic Lesions<br>Combination Product: VRS | Other: Vessel Restoration System (VRS)<br>* Vessel Restoration System (VRS) for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety | To assess the safety of the VRS by way of occurence of advese events during the index procedure | 12 months | 
| To assess efficacy | To assess the efficacy of the VRS as determined by lesion patency through 1 year | 12 months |