Physician-initiated Trial Investigating the MOTIV™ Bioresorbable Scaffold (Reva Medical) for the Treatment of Below-The-Knee Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Dr. Sabrina Overhagen
- Enrollment
- 58
- Locations
- 8
- Primary Endpoint
- safety endpoint - rate of serious device-related adverse events within 30 days post-op
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 36 months) outcome of the MOTIV™ Bioresorbable Scaffold (Reva Medical) in a controlled prospective investigation for the treatment of patients with rest pain or minor tissue loss (CLI) due to the presence of lesions of max 100mm in length at the level of the below-the-knee arteries.
Investigators
Dr. Sabrina Overhagen
Director
FCRE (Foundation for Cardiovascular Research and Education)
Eligibility Criteria
Inclusion Criteria
- •Patient is willing to comply with specified follow-up evaluations at the specified times
- •Patient presenting with rest pain or minor tissue loss (Rutherford classification from 4 to 5)
- •Patient is \>18 years old
- •Patient understands the nature of the procedure and provides written informed consent, prior to enrollment in the study - Patient has a projected life-expectancy of at least 24-months
- •Patient is eligible for treatment with the MOTIV™ Bioresorbable Scaffold
- •Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
- •De novo lesion or Restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
- •Target vessel diameter visually estimated to be ≥2.5mm and ≤3.50mm
- •Guidewire and delivery system successfully traversed the lesion
- •Total target lesion is maximally 100mm
Exclusion Criteria
- •The reference segment diameter is not suitable for the available stent design
- •Untreated flow-limiting aortoiliac stenotic disease
- •Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment.
- •Any previous surgery in the target vessel
- •Aneurysm located at the target vessel
- •Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
- •Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy.
- •Major distal amputation (above the transmetatarsal) in the study or non-study limb.
- •Septicemia or bacteremia
- •Any previously known coagulation disorder, including hypercoagulability
Outcomes
Primary Outcomes
safety endpoint - rate of serious device-related adverse events within 30 days post-op
Time Frame: 30 days post-op
Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure.
efficacy endpoint - Primary Patency rate at 12-months post-op
Time Frame: 12 months post-op
Primary patency defined as no evidence of at least 50% restenosis or reocclusion within the originally treated lesion based on color-flow-duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and/or angiography (left at the discretion of the investigator) without target lesion revascularization (TLR) within 12 months.
Secondary Outcomes
- Technical Success(1-day post-op)
- Primary Patency rate at follow-up visits(1 month, 6 months, 12 months, 24 months and 36 months post-op)
- Clinically-driven target lesion revascularization (TLR) at 1, 6, 12, 24 and 36-months(1 month, 6 months, 12 months, 24 months and 36 months post-op)
- Limb-Salvage rate at follow-up visits(1 month, 6 months, 12 months, 24 months and 36 months post-op)
- Clinical success at follow-up visits(1 day post-op and 1 month, 6 months, 12 months, 24 months and 36 months post-op)
- Serious adverse events during the study (within 36 months post-op)(within 36 months post-op)