SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries (NCT04971772) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SIGNATURE Study : DCB (Legflow) vs POBA in Fempop Arteries
Brazil, Germany150 participantsStarted 2022-06-08
Plain-language summary
The aim of this study is to demonstrate the superiority in safety and efficacy of the Legflow DCB vs standard uncoated POBA in a randomized controlled (RCT) for treatment of patients with symptomatic peripheral artery disease (PAD) due to stenosis, restenosis or occlusion of the femoral and/or popliteal arteries.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
* Patient is ≥18 years
* Patient has Rutherford Classification 2,3 or4.
* Patient has provided written informed consent and is willing to comply with study follow-up requirements.
* De novo stenotic or occlusive lesion(s) or non-stented restenotic or occlusive lesion(s) occurring \>90 days after prior plain old balloon (POBA) angioplasty or \>180 days after prior DCB treatment.
* Target lesion is located between the ostium of the SFA and the end of the P1 segment of the popliteal artery
* Target vessel diameter ≥ 4 mm and ≤ 7 mm
* Target lesion must be stenotic or occlusive lesion ≤ 150mm in length (one long lesion or tandem lesions) by investigator's visual estimate. \[Note: tandem lesions must have a total length of ≤ 150 mm by visual estimate and be separated by ≤ 30 mm.\]
* Target lesion must have angiographic evidence of ≥ 70 % stenosis by investigator's visual estimation
* Successful, uncomplicated crossing of the target lesion occurs when the tip of the guidewire is distal to the target lesion without the occurrence of flow-limiting dissection of perforation and is judged by visual inspection to be within the true lumen. Subintimal dissection techniques may be used if re-entry occurs above-the-knee (ATK) and without the use of re-entry devices.
* Target lesion is located at least 30mm from any stent if target vessel was previously stented.
* A patent inflow artery free from significant stenosis ((≥50% stenosis) as confirmed by angiography.
* At leas…
What they're measuring
1
Primary Efficacy Endpoint:
Timeframe: 12 months post-procedure
2
Device- and procedure-related death
Timeframe: 30 days post-procedure
3
Major target limb amputation and clinically-driven target vessel revascularization