Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses

NCT02936622 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2024-04-05

No results posted yet for this study

Summary

This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.

Conditions

  • Peripheral Arterial Disease (PAD)

Interventions

DEVICE

Zilver® Paclitaxel-Eluting Peripheral Stent

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

DEVICE

Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

DEVICE

Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating

Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Sponsors & Collaborators

  • Cook Group Incorporated

    lead INDUSTRY

Principal Investigators

  • Thomas Zeller, Prof. Dr. med. · Universitäts Herzzentrum Freiburg - Bad Krozingen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-21
Primary Completion
2019-04-23
Completion
2023-10-25

Countries

  • Germany
  • New Zealand

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 NCT02936622 on ClinicalTrials.gov