Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/… (NCT04546477) | Clinical Trial Compass
CompletedNot Applicable
Prospective Multicenter Study to Confirm the Performance of the Renzan Stent in Treatment of SFA/POP Artery Disease
Belgium, France, Germany135 participantsStarted 2020-07-30
Plain-language summary
The primary objective of this study is to confirm the safety and efficacy of the RenzanTM Peripheral Stent System when used for treatment of superficial femoral (SFA) and/or popliteal (POP) artery disease.
This trial plans to include 135 patients in (up to) 10 locations around in Europe.
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
. Age ≥18 years.
. Subject must provide written informed consent prior to the treatment of the target lesion.
. Subject must be willing to comply with the specified follow-up evaluation schedule.
. Subject with Rutherford-Becker clinical classification category 2 to 5, with a resting ankle-brachial index (ABI) ≤ 0.9.
. A superficial femoral and/or popliteal artery lesion with \> 50% stenosis or total occlusion.
. Stenotic or occluded lesion(s) within the same vessel (one long or multiple serial lesions treatable with one stent) ≥ 40 mm and ≤ 140 mm in length, with reference vessel diameter (RVD) ≥ 4.0 mm and ≤ 7.0 mm by visual assessment.
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.
. A patent inflow artery free from significant lesion (≥50% stenosis) as confirmed by angiography (treatment of target lesion acceptable after successful treatment of ipsilateral iliac lesions); Successful ipsilateral iliac artery treatment is defined as attainment of residual diameter stenosis ≤30% without death or major vascular complication, either with PTA or stenting.
. The target lesion(s) can be successfully crossed with a guide wire and dilated up to 1:1 to healthy vessel (as per operator's assesment).
Exclusion criteria
. Subject has Rutherford-Becker classification category 6.
. Treatment of lesions requiring the use of adjunctive debulking devices.
. The use of drug-coated balloons at any step of the procedure.
. Required stent placement via a popliteal approach.
. Required stent placement across or within 0.5 cm of the superficial and profunda femoral artery bifurcation.
. In-stent restenosis treatment or any other procedure which requires stent-in-stent placement to obtain patency.
. Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
. Lesion with the length that would require stent overlap.