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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

NCT07122167 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-09-12

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

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.

Sponsors & Collaborators

  • Zylox-Tonbridge Medical Technology Co., Ltd.

    collaborator UNKNOWN

  • MDCECRO LLC

    lead NETWORK

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-06-02
Primary Completion
2026-12-31
Completion
2027-02-01

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 NCT07122167 on ClinicalTrials.gov