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NOT YET RECRUITING
NCT07049120
NA

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

Sponsor: Zhejiang Zylox Medical Device Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

153

Start Date

2025-06-30

Completion Date

2027-10-31

Last Updated

2025-07-03

Healthy Volunteers

No

Interventions

DEVICE

ZENFLEX Pro™ Peripheral Drug-eluting Stent System

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.

Locations (1)

American Heart of Poland, Małopolskie Cardiovascular Center PAKS Chrzanów

Chrzanów, Chrzanów, Poland