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

NCT07049120 | Not Yet Recruiting

• 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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reaching Primary Patency

  Primary 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 post-procedure

Secondary Outcomes (8)

• Number of participants with successful stent delivery and deployment resulting in ≤30% residual stenosis

  During the procedure

• Number of participants with procedural success (technical success and no MAEs within 24 hours)

  Within 24 hours post-procedure

• Number of participants with primary patency

  6 months post-procedure

• Number of participants with secondary patency

  6 and 12 months post-procedure

• Number of participants undergoing target lesion revascularization (TLR)

  At 1, 6, and 12 months post-procedure

Study Arms (1)

ZENFLEX Pro

EXPERIMENTAL

Subjects in this arm will receive treatment with the ZENFLEX Pro™ Peripheral Drug-eluting Stent System for femoropopliteal artery stenosis or occlusion. The procedure will be performed according to the device's instructions for use (IFU). Follow-up assessments will be conducted at 1, 6, and 12 months post-procedure to evaluate safety, efficacy, and performance outcomes.

Device: ZENFLEX Pro™ Peripheral Drug-eluting Stent System

Interventions

ZENFLEX Pro™ Peripheral Drug-eluting Stent System DEVICE

The ZENFLEX Pro™ Peripheral Drug-eluting Stent System will be implanted in patients with femoropopliteal artery lesions to evaluate safety and efficacy outcomes. The device is designed to provide mechanical support and deliver antiproliferative drug locally to reduce restenosis. The procedure will be performed via standard endovascular techniques.

ZENFLEX Pro

Eligibility Criteria

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

You may qualify if:

• 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.
• 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:

• 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).
• The target lesion requires the use of plaque excision, laser, or other debulking devices that may damage the vessel intima.

Sponsors & Collaborators

• Zhejiang Zylox Medical Device Co., Ltd.: lead

Study Sites (1)

American Heart of Poland, Małopolskie Cardiovascular Center PAKS Chrzanów

Chrzanów, Chrzanów, 32-500, Poland

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Tao Liu

  Zhejiang Zylox Medical Device Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Przemysław Nowakowski

CONTACT

+48 32 625 81 20; nowakowski.mcsn@gmail.com

Study Design

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

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: July 3, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)