Clinical Trial

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

Name: Post-Market Study of ZENFLEX Pro Stent for Femoropopliteal Artery Lesions — clinical trial record (NCT07049120)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

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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.

Trial Details

NCT Number	NCT07049120
Lead Sponsor	Zhejiang Zylox Medical Device Co., Ltd.
Conditions	Peripheral Arterial Disease
Enrollment	153 participants
Start Date	2025-06-30
Primary Completion	2027-05-31 (estimated)
Study Completion	2027-10-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-03