Actively Recruiting
Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions
Led by MDCECRO LLC · Updated on 2025-09-12
153
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
Sponsors
M
MDCECRO LLC
Lead Sponsor
Z
Zylox-Tonbridge Medical Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years, any gender.
- Chronic, symptomatic lower limb ischemia classified as Rutherford categories 2, 3, 4, or 5.
- Able and willing to provide consent and attend all required follow-up visits.
- Lesion(s) located in the native superficial femoral artery and/or proximal popliteal artery (P1 segment) with 70% stenosis by angiographic assessment.
- Vessel diameter between 4.0 mm and 6.5 mm.
- Total lesion length between 10 mm and 140 mm, covered by one stent.
- Chronic total occlusion with lesion length 120 mm.
- Patent popliteal and infrapopliteal arteries with at least one vessel patent (less than 50% stenosis) to the ankle or foot.
You will not qualify if you...
- Pregnant or breastfeeding women, or those planning to conceive.
- History of or planned major amputation at or above the ankle.
- Allergy or intolerance to device materials or related drugs including nitinol, paclitaxel, aspirin, clopidogrel, heparin, rivaroxaban, or contrast agents.
- Serum creatinine above 2.5 mg/dL or currently on dialysis.
- Known, uncorrectable bleeding disorders or severe coagulation dysfunction.
- Previously stented target lesion or vessel.
- Target lesion treated with drug-coated balloon within 12 months prior to enrollment.
- Life expectancy less than 1 year.
- Received thrombolysis treatment within 48 hours prior to enrollment.
- Major clinical diseases or unstable conditions within past 3 months including severe heart failure, unstable angina, myocardial infarction, stroke, severe neurological or psychiatric history, severe infections, gastrointestinal bleeding, or active disseminated intravascular coagulation.
- Currently participating in another clinical trial involving drugs or devices.
- Investigator considers subject unsuitable for trial participation.
- Presence of aneurysm in the target vessel.
- Heavily calcified lesions (PACSS grades 3-4).
- Target lesion requiring plaque excision, laser, or debulking devices that may damage vessel lining.
- Inability to pass guidewire through target lesion or inability to use balloon for pre-dilation.
- Acute ischemia or thrombosis of the superficial femoral or proximal popliteal artery prior to enrollment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cardiovascular
Chrzanów, Chrzanow, Poland, 32-500
Actively Recruiting
Research Team
Q
Qiqing BO, Clinical Operations Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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