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Safety and Effectiveness Study of EverFlex Stent to Treat Symptomatic Femoral-popliteal Atherosclerosis

NCT00530712 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 287

Last updated 2019-02-18

Study results available
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Summary

This is a multi-center, non-randomized, single arm study to compare PTA and primary stenting using a single PROTÉGÉ® EverFlex™ stent to performance goals of PTA alone in the treatment of atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions.

Conditions

  • Peripheral Vascular Diseases
  • Claudication

Interventions

DEVICE

PROTÉGÉ® EverFlex™ Self-Expanding Stent System

Implantation of a single study device in the native superficial femoral artery or superficial femoral artery and proximal popliteal artery.

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Jon Matsumura, MD · University of Wisconsin, Madison

  • Krishna Rocha-Singh, MD · Prairie Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2012-03-31
Completion
2013-07-31

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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 NCT00530712 on ClinicalTrials.gov