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Zilver PTX Drug-Eluting Peripheral Stent Study

NCT01348425 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-02-02

Study results available
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Summary

This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Longer Zilver PTX Stents

Treatment with at least one 100 mm or longer Zilver PTX stent

DEVICE

Shorter Zilver PTX Stents

Treatment with Zilver PTX stents 80 mm or shorter only

Sponsors & Collaborators

  • Cook Group Incorporated

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. med. Jens Ricke · Universitätsklinikum Magdeburg A.ö.R., Department for Radiology and Nuclear Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2011-10-31
Completion
2012-09-30

Countries

  • Germany
  • Switzerland

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 NCT01348425 on ClinicalTrials.gov