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Zilver® PTX™ Global Registry

NCT01094678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 788

Last updated 2014-09-11

No results posted yet for this study

Summary

The Zilver PTX Registry Study is a prospective, non-randomized, open-label, multicenter single-arm study enrolling patients in Europe, Asia, and North America with de novo or restenotic (including in-stent restenosis) lesions of the above-the-knee femoropopliteal artery (SFA). The primary endpoint of the study is event-free survival (EFS) at 6 months.

Conditions

  • Peripheral Arterial Disease
  • Peripheral Vascular Disease

Interventions

DEVICE

Zilver® PTX™ Stent

Stenting of the superfemoropopliteal artery.

Sponsors & Collaborators

  • Cook Group Incorporated

    lead INDUSTRY

Principal Investigators

  • Michael Dake, MD · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2009-01-31
Completion
2011-04-30

Countries

  • Germany
  • Italy

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 NCT01094678 on ClinicalTrials.gov