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

NCT07049120 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-07-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Zhejiang Zylox Medical Device Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Tao Liu · Zhejiang Zylox Medical Device Co., Ltd.

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-05-31
Completion
2027-10-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07049120 on ClinicalTrials.gov