Safety and Efficacy of the SurVeilâ„¢ Drug-Coated Balloon (NCT03241459) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of the SurVeilâ„¢ Drug-Coated Balloon
United States446 participantsStarted 2017-10-23
Plain-language summary
To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subject is ≥18 years.
* Subject has target limb Rutherford classification 2, 3 or 4.
* Subject has provided written informed consent and is willing to comply with study follow-up requirements.
* De novo lesion(s) or non-stented restenotic lesion(s) occurring \>90 days after prior plain old balloon (POBA) angioplasty or \>180 days after prior DCB treatment.
* Target lesion location starts ≥10 mm below the common femoral bifurcation and terminates distally at or above the end of the P1 segment of the popliteal artery.
* Target vessel diameter ≥4 mm and ≤7 mm.
* Target lesion must have angiographic evidence of ≥70% stenosis by operator visual estimate.
* Chronic total occlusions may be included only after successful, uncomplicated wire crossing of target lesion via an anterograde approach and without the use of subintimal dissection techniques.
* Target lesion must be ≤180 mm in length (one long lesion or multiple serial lesions) by operator visual estimate. Note: combination lesions must have a total lesion length of ≤180 mm by visual estimate and be separated by ≤30 mm.
* Target lesion is located at least 30 mm from any stent, if target vessel was previously stented.
* Successful, uncomplicated (without use of a crossing device) wire crossing of target lesion. Successful crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation and is judged by visu…
What they're measuring
1
Primary Lesion Patency Though 12 Months
Timeframe: 12 months
2
Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)