Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions

Launched by ZHEJIANG ZYLOX MEDICAL DEVICE CO., LTD. · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medical device called the ZENFLEX Pro™ stent, which is designed to help open up narrowed or blocked arteries in the leg (specifically in the femoropopliteal artery). This condition, known as Peripheral Arterial Disease, can cause pain and difficulty walking due to reduced blood flow. The study aims to see how safe and effective this stent is over time, with patients being followed for up to one year after receiving the treatment.

Adults aged 18 to 80 who have symptoms of poor blood flow in their legs and meet certain artery blockage criteria may be eligible to join. Participants will receive the stent to treat their artery narrowing or blockage and will have follow-up visits at 1, 6, and 12 months to check on their progress. The main goal is to see if the treated artery stays open after one year. People who are pregnant, have serious health issues, or have had certain prior treatments may not qualify. This study is not yet recruiting participants but aims to provide important information about this stent’s performance in real-world use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Clinical 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:
• 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:
• • 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.