Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Ste… (NCT07122167) | Clinical Trial Compass
RecruitingNot Applicable
Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions
Poland153 participantsStarted 2025-06-02
Plain-language summary
This is a prospective, multi-center, single-arm post-market study evaluating the safety and effectiveness of the ZENFLEX Pro™ Drug-eluting Stent in treating femoropopliteal artery stenosis or occlusion. A total of 153 subjects will be followed at 1, 6, and 12 months. The primary endpoint is primary patency at 12 months.
Who can participate
Age range
18 Years – 80 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
. Stenotic, restenotic or occlusive lesion(s) located in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) (i.e., within the P1 segment):
. Degree of stenosis ≥70% by visual angiographic assessment.
. Vessel diameter ≥4.0 mm and ≤6.5 mm.
. Total lesion length (or series of lesions) ≥ 10 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one stent).
. Chronic total occlusion with a total lesion length of ≤120 mm.
. Patent popliteal and infrapopliteal arteries, with single-vessel runoff or better, defined as at least one of the three vessels remaining patent (i.e., \<50% stenosis) down to the ankle or foot.
Exclusion criteria
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.
. Pregnant or breastfeeding women, or women/men planning to conceive.
. Subjects who have had or are planned for major amputation (at or above the ankle level).
. Subjects known to be allergic or intolerant to materials used in the investigational device or treatment drugs, including nitinol, paclitaxel, aspirin, clopidogrel, heparin, rivaroxaban, contrast agents, etc.
. Subjects with serum creatinine ≥2.5 mg/dL or currently undergoing dialysis.
. Subjects with known, uncorrectable hemorrhagic disorders or severe coagulation dysfunction (prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≥2 times the upper limit of normal, or platelet count \<80×10⁹/L).
. Previously stented target lesion/vessel.
. Target lesion/vessel previously treated with drug-coated balloon \<12 months prior to enrollment.
. Subjects with a life expectancy of less than 1 year.