To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA
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
. ≥ 18 years of age;
. Rutherford Clinical Category 2-4;
. The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, is willing to provide 5-year informed consent and has duly signed the informed consent form (ICF).
. Significant (≥ 70%) stenosis or occlusion of a native femoropopliteal artery (by visual estimate) that is amenable to DCB with or without stenting;
. TASC II Class C or D Lesions with intended target lesion treatment segment(s) cumulatively ≥14 cm in length;
. de novo lesion(s) or non-stented restenotic lesion(s) \> 90 days from prior angioplasty procedure;
. Proximal margin of target lesion(s) starts ≥ 1 cm below the common femoral bifurcation;
. Distal margin of target lesion(s) terminates at bifurcation of popliteal artery AND ≥1 cm above the origin of the TP trunk;
Exclusion criteria
. 1\. Women who are pregnant, lactating, or planning on becoming pregnant or men intending to father children;
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
Overall Medical Safety
Timeframe: 12 Months
2
Primary Endpoint Efficacy, measured by presence of primary patency of the target lesion. Patency is assessed by a Corelab based on ultrasound images
. Patient is contraindicated to use Lutonix Drug Coated Balloon per the current Instructions For Use (IFU)
. Life expectancy of \< 1year;
. Patient is currently participating in an investigational drug or other device study or previously enrolled in this study; NOTE: Enrollment in an investigational device or pharmaceutical clinical trial during the follow up period is not allowed.
. History of stroke within 3 months;
. History of myocardial infarction, thrombolysis or angina within 2 weeks of enrollment;
. Prior vascular surgery of the index limb, with the exception of endarterectomy or remote common femoral patch angioplasty, separated by at least 1 cm from the target lesion;
. Target lesion involves a previously placed stent