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ZENFlex-Registry to Evaluate the Outcome of Bare Metal Stent-assisted Angioplasty

NCT03751527 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-08-31

No results posted yet for this study

Summary

A prospective, multi-center, single-arm registry to evaluate the safety and efficacy of bare metal stent-assisted percutaneous transluminal angioplasty (PTA) in the treatment of superficial femoral and/or proximal popliteal artery (P1) lesions in patients with symptomatic peripheral artery disease

Conditions

  • Atherosclerosis of Femoral Artery

Interventions

DEVICE

ZENFLEX peripheral stent system

The ZENFLEX Peripheral Stent System is designed to deliver a self-expanding stent to the iliac artery, superficial femoral arteries and / or proximal popliteal arteries to improve luminal diameter. The self-expanding stent is composed of nickel titanium alloy (nitinol); contains a total of 12 tantalum / gold radiopaque markers and imparts an outward radial force on the luminal surface of the vessel to establish patency.

Sponsors & Collaborators

  • Zhejiang Zylox Medical Device Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dierk Scheinert · Universitätsklinikum Leipzig

  • Annett Glanz · Diakoniekrankenhaus Halle

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Germany

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 NCT03751527 on ClinicalTrials.gov