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

NCT07122167 | Recruiting DMC

• 1 other identifier: CE-02
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial disease

Outcome Measures

Primary Outcomes (1)

• Primary patency at 12 months post-procedure

  Primary vessel patency is defined as a binary endpoint and will be determined to be a success when the duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤2.4 at the 12-month follow-up visit in the absence of clinically driven TLR or bypass of the target lesion.

  12 Months

Study Arms (1)

Prospective, Multi-center, Single-arm.

OTHER

Device: Peripheral Drug-eluting Stent System

Interventions

Peripheral Drug-eluting Stent System DEVICE

Drug-eluting stents (DES) are increasingly used in the treatment of PAD. These stentsare coated with antiproliferative drugs designed to provide mechanical support within the artery while releasing the drug gradually to reduce the risk of restenosis. Commonly used drugs include paclitaxel, sirolimus, and everolimus, which inhibit vascular smooth muscle cell proliferation, thereby reducing the likelihood of re-occlusion.

Prospective, Multi-center, Single-arm.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.
• Eligible subjects must meet all of the following angiographic 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.

You may not qualify if:

• Subjects will be excluded from the study if any of the following conditions are present:
• 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.
• Subjects who have received local or systemic thrombolysis treatment within 48 hours prior to enrollment.
• 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.
• Subjects currently participating in another clinical trial involving drugs or medical devices.
• Subjects whom the investigator considers unsuitable for participation in the clinical trial.
• Presence of aneurysm in the target vessel.
• Heavily calcified lesions (Peripheral Arterial Calcium Scoring System \[PACSS\] grades 3-4).

Sponsors & Collaborators

• MDCECRO LLC: lead
• Zylox-Tonbridge Medical Technology Co., Ltd.: collaborator

Study Sites (1)

Cardiovascular

Chrzanów, Chrzanow, 32-500, Poland

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Qiqing BO, Clinical Operations Manager

CONTACT

+86 18610591755; qq.bo@zyloxmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

PL (1)