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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Symic Vascular
- Enrollment
- 66
- Locations
- 8
- Primary Endpoint
- Incidence of treatment-emergent adverse events
- Last Updated
- 9 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of treatment-emergent adverse events
Time Frame: through 24 weeks
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
Late Lumen Loss
Time Frame: 24 weeks
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.