Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis

Study Overview
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Brief Summary
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The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.

Detailed Description
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This first-in-human study will evaluate the safety and effectiveness of a novel adjunctive therapy, SBCV, used with balloon angioplasty as compared to balloon angioplasty plus a control agent (saline) when used for the treatment of stenosis within the femoropopliteal artery. Effectiveness will be measured by late lumen loss at 24 weeks post treatment as evaluated by an independent, blinded core lab.

Official Title
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A Multicenter, Parallel, Blinded, Randomized Comparison of the Safety and Efficacy of Balloon Angioplasty Plus Intraluminal SBCV To Balloon Angioplasty Alone for Treatment of Stenosis or Occlusion Within the Femoropopliteal Artery

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Other: SBCV
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for balloon angioplasty for stenosis of femoropopliteal lesion(s) Rutherford Clinical Category 1-4 (claudication or critical limb ischemia) Lesions are ≥70% stenosis by visual estimate A patent inflow artery free from significant lesion At least one patent native outflow artery to the ankle Exclusion Criteria: History of haemorrhagic stroke within 3 months of screening History of myocardial infarction, thrombolysis or angina within 2 weeks of screening Renal failure or chronic kidney disease Severe calcification that renders the lesion undilatable

Ages Eligible for Study
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Minimum Age: 40 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBCV<br>SBCV is administered to the site immediately post balloon dilation. | Other: SBCV<br>* SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.<br>|
| Placebo Comparator: Control<br>Saline is used as a control and is delivered immediately post balloon dilation. | Other: Saline<br>* Saline is used as a control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-emergent adverse events | The composite of no all-cause perioperative (≤30 day) mortality and none of the following events at 24 weeks following treatment: Index limb amputation (above or below the ankle) Index limb re-intervention Index-limb-related death | through 24 weeks | 
| Late Lumen Loss | LLL is defined as the difference between the minimum lumen diameter (MLD) immediately post-primary procedure and the MLD at follow-up as measured by an independent, blinded core lab. | 24 weeks |