ZENFLEX Pro™ drug-eluting stent for femoropopliteal artery blockages

Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesion

This will test the ZENFLEX Pro drug-eluting stent to open narrowed or blocked femoropopliteal arteries in adults with symptomatic peripheral arterial disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 153 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Mdcecro LLC (Research network)
• Locations: 1 site (Chrzanów, Chrzanow)
• Trial ID: NCT07122167 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, single-arm post-market registry enrolling up to 153 adults with symptomatic femoropopliteal artery stenosis or occlusion. Participants will receive the ZENFLEX Pro peripheral drug-eluting stent and be followed with clinical visits and imaging at 1, 6, and 12 months. The primary endpoint is primary patency at 12 months, with safety and device performance monitored throughout follow-up. Lesion eligibility includes native superficial femoral and proximal popliteal segments with vessel diameters 4.0–6.5 mm and lesion lengths within the 10–140 mm range (CTOs ≤120 mm where applicable).

Who should consider this trial

Good fit: Ideal candidates are adults 18–80 with symptomatic PAD (Rutherford categories 2–5) who have target lesions in the native superficial femoral or proximal popliteal artery that meet the trial's size and length criteria.

Not a fit: Patients with vessel diameters outside 4.0–6.5 mm, lesions longer than the allowed limits, lesions outside the SFA/PPA, or significant comorbidities may not receive benefit from this device.

Why it matters

Potential benefit: If successful, the device could keep treated arteries open longer, reducing leg symptoms and the need for repeat procedures.

How similar studies have performed: Prior trials of peripheral drug-eluting stents and drug-coated technologies have shown improved 12-month patency compared with bare-metal devices, though outcomes vary by device and lesion complexity.

Eligibility criteria

Inclusion Criteria:

* (1) Aged 18 to 80 years, regardless of gender. (2) Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3, 4 or 5. (3) 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.

Angiographic Inclusion Criteria:

Eligible subjects must meet all of the following angiographic criteria:

1. 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):

   1. Degree of stenosis ≥70% by visual angiographic assessment.
   2. Vessel diameter ≥4.0 mm and ≤6.5 mm.
   3. Total lesion length (or series of lesions) ≥ 10 mm and ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one stent).
   4. Chronic total occlusion with a total lesion length of ≤120 mm.
2. 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:

* Clinical exclusion criteria:

Subjects will be excluded from the study if any of the following conditions are present:

1. Pregnant or breastfeeding women, or women/men planning to conceive.
2. Subjects who have had or are planned for major amputation (at or above the ankle level).
3. 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.
4. Subjects with serum creatinine ≥2.5 mg/dL or currently undergoing dialysis.
5. 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).
6. Previously stented target lesion/vessel.
7. Target lesion/vessel previously treated with drug-coated balloon \<12 months prior to enrollment.
8. Subjects with a life expectancy of less than 1 year.
9. Subjects who have received local or systemic thrombolysis treatment within 48 hours prior to enrollment.
10. Subjects diagnosed with major clinical diseases or unstable conditions within the past 3 months, such as severe heart failure, unstable angina, myocardial infarction, transient ischemic attack or stroke, severe neurological or psychiatric history, severe infections, gastrointestinal bleeding, or active disseminated intravascular coagulation.
11. Subjects currently participating in another clinical trial involving drugs or medical devices.
12. Subjects whom the investigator considers unsuitable for participation in the clinical trial.

Angiographic exclusion criteria:

1. Presence of aneurysm in the target vessel.
2. Heavily calcified lesions (Peripheral Arterial Calcium Scoring System \[PACSS\] grades 3-4).
3. The target lesion requires the use of plaque excision, laser, or other debulking devices that may damage the vessel intima.
4. The guidewire cannot pass through the target lesion, or percutaneous transluminal angioplasty (PTA) balloon cannot be used for pre-dilation.
5. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to enrollment.

Where this trial is running

Chrzanów, Chrzanow

• Cardiovascular — Chrzanów, Chrzanow, Poland (Recruiting)

Study contacts

• Study coordinator: Qiqing BO, Clinical Operations Manager

Conditions Peripheral Arterial Disease; peripheral arterial disease