Clinical Trial

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

Recruiting
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-08-07; most recent amendment 2025-09-05.
Trial Details
NCT Number NCT07122167
Lead Sponsor MDCECRO LLC
Collaborators: Zylox-Tonbridge Medical Technology Co., Ltd.
Conditions Peripheral Arterial Disease
Enrollment 153 participants
Start Date 2025-06-02
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-12