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

Sponsor
Zhejiang Zylox Medical Device Co., Ltd.
Study ID
NCT07049120
Status
Not Yet Recruiting

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Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 3, 2025
Start date
Jun 30, 2025
Status verified
Jun 2025
Primary completion
May 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
153 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: ZENFLEX Pro
    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.

Primary Outcome Measure

Number of Participants Reaching Primary Patency [ Time Frame: 12 months post-procedure ]

Central Contacts

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