CVI Drug Coated Balloon First In Human Trial

Study Overview
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Brief Summary
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The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or popliteal arteries. The primary endpoint for this analysis is late lumen loss at six (6) months.

Detailed Description
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Prospective, controlled, multi-center, open, single arm study Main cohort: 50; pre-specified treatment group: 30. Total patients: 80

Official Title
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Prospective, Controlled, Multi-Center, Open, Single Arm Study for the Treatment of Subjects Presenting De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using a Paclitaxel-Coated Percutaneous Angioplasty Catheter

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: Percutaneous Transluminal Angioplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with symptomatic leg ischemia, 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). Target vessel reference diameter ≥3 mm and ≤7 mm (by visual estimation). Rutherford classification of 2, 3 or 4 Exclusion Criteria: 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. 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.

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: CVI Drug Coated Balloon<br> | Device: Percutaneous Transluminal Angioplasty<br> <br> * Other names: Catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint: Angiographic late lumen loss | difference between minimum lumen diameter after intervention and follow up. | 6Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary safety endpoint: Major Adverse Event (MAE) rate | composite rate of cardiovascular death, index limb amputation and ischemia driven target lesion revascularization (TLR). | 6Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease