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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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