NCT07049120

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: Zhejiang Zylox Medical Device Co., Ltd. · Industry
• 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.

Detailed description

This is a prospective, multi-center, single-arm, post-market registry study designed to ensure continued evaluation of real-world safety, performance and efficacy of the ZENFLEX Pro™ Peripheral Drug-eluting Stent System in the treatment of femoropopliteal artery stenosis or occlusion. A total of 153 subjects will be enrolled in this study. Follow-up visits will be scheduled at 1-, 6-, and 12-months post-procedure. The primary endpoint is primary patency at 12 months. Secondary endpoints include technical success, procedural success, secondary patency rate, target lesion revascularization (TLR), clinically driven target lesion revascularization (CD-TLR), Rutherford classification, and ankle-brachial index (ABI). Safety endpoints include major adverse events, adverse events, all-cause mortality, major amputations, minor amputations, and stent fractures.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-06-30
• Primary completion: 2027-05-31
• Completion: 2027-10-31
• First posted: 2025-07-03
• Last updated: 2025-07-03

Locations

1 site across 1 country: Poland