Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions (NCT07049120) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions
Poland153 participantsStarted 2025-06-30
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 range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Aged 18 to 80 years, regardless of gender.
✓. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5.
✓. Subject (or legal guardian, if applicable) is willing and able to provide consent before to the performance of any study-specific tests or procedures, has signed the consent form and agrees to attend all required follow-up visits.
✓. 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.
Exclusion criteria
✕. 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.