NCT07122167

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: MDCECRO LLC · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Peripheral Drug-eluting Stent System	Drug-eluting stents (DES) are increasingly used in the treatment of PAD. These stentsare coated with antiproliferative drugs designed to provide mechanical support within the artery while releasing the drug gradually to reduce the risk of restenosis. Commonly used drugs include paclitaxel, sirolimus, and everolimus, which inhibit vascular smooth muscle cell proliferation, thereby reducing the likelihood of re-occlusion.

Timeline

• Start date: 2025-06-02
• Primary completion: 2026-12-31
• Completion: 2027-02-01
• First posted: 2025-08-14
• Last updated: 2025-09-12

Locations

1 site across 1 country: Poland