CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery

Study Overview
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Brief Summary
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The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/restenotic superficial femoral or popliteal arteries.

Detailed Description
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The CVT-SFA Trial is a prospective, multi-center, open, single arm study enrolling subjects with de-novo or post-PTA occluded/stenotic or re-occluded/ restenotic lesions (excluding in-stent lesions) ≤150mm in length in femoropopliteal arteries with reference vessel diameters of 4-6mm, receiving up to two (2) CVT Everolimus-coated PTA Catheters to establish blood flow and to maintain vessel patency.

Official Title
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Chansu Vascular Technologies Everolimus-Coated Balloon Percutaneous Transluminal Angioplasty Catheter First-in-Human Clinical Investigation

Conditions
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Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion, Popliteal Artery Occlusion

Intervention / Treatment
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* Device: Peripheral PTA with a drug coated balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be at least 18 years of age. Subject provides written informed consent prior to any clinical investigation related procedure, as approved by the appropriate Ethics Committee of the respective clinical site. Subject must agree to undergo all clinical investigation plan-required follow-up visits and examinations. Subjects with symptomatic leg ischemia who do not respond favorably to Exercise Therapy or with symptoms that impact significantly daily life, requiring treatment of SFA or popliteal (P1 segment) artery. De novo or restenotic lesion(s) >70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation). Lesion must be at least 2 cm from any stented area. Subject is willing to comply with the required follow up visits, testing schedule and medication regimen. Successful wire crossing of lesion. Target vessel reference diameter ≥4 mm and ≤6 mm (by visual estimation). Target lesion(s) can be treated with a maximum of two (2) CVT Everolimus-coated PTA Catheters. At least one patent (less than 50% stenosis) tibio-peroneal run-off vessel confirmed by baseline angiography or prior MR angiography or CT angiography. Life expectancy >1 year Rutherford classification of 2, 3 or 4. Exclusion Criteria: Pregnant or lactating females. Co-existing clinically significant aneurismal disease of the abdominal aorta, iliac or popliteal arteries. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy. Known intolerance to study medications, everolimus or contrast agents. Doubts in the willingness or capability of the subject to allow follow-up examinations. Subject is actively participating in another investigational device or drug study. History of hemorrhagic stroke within 3 months of procedure. Previous or planned surgical or interventional procedure within 30 days of index procedure. Prior vascular surgery of the target lesion. Lesion length is <3 cm or >15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured. Known inadequate distal outflow. Significant inflow disease. Acute or sub-acute thrombus in target vessel. Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloons, brachytherapy, lithotripsy). Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure. Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure. Rutherford classification of 0, 1, 5 or 6 Presence of prohibitive calcification that precludes adequate PTA treatment. Subjects held in custody in an institution by official or court order. Subject is not covered by any medical insurance coverage.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Everolimus-coated balloon<br>Treatment of occlusion or stenosis in Superficial Femoral Artery and Proximal Popliteal Artery with drug-coated balloon | Device: Peripheral PTA with a drug coated balloon<br>* Peripheral artery angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom of Major Adverse Event (MAE) rate | Composite rate of cardiovascular death, index limb amputation and ischemia-driven target lesion revascularization (TLR). | 6 months post-procedure | 
| Patency | Freedom from restenosis as determined by duplex ultrasonography (DUS) (peak systolic velocity ratio (PSVR) ≤2.4 or ≤50% stenosis) and freedom from ischemia-driven target lesion revascularization (TLR). | 6 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of MAE | Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR). | One year post-procedure | 
| Patency | Freedom from clinically driven TLR and duplex ultrasonography detected restenosis (ultrasound peak systolic velocity ratio ≤ 2.4 or stenosis ≤50%) | 12 months post procedure |