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Post-market Registry Study on the Safety and Efficacy of ZENFLEX Pro™ Peripheral Drug-eluting Stent System for Femoropopliteal Artery Lesions
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.
Details
| Lead sponsor | MDCECRO LLC |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 153 |
| Start date | Mon Jun 02 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Feb 01 2027 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Peripheral Arterial Disease
Interventions
- Peripheral Drug-eluting Stent System
Countries
Poland