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Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study

NCT00673985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2017-07-14

No results posted yet for this study

Summary

The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral artery (SFA) disease by reducing the re-intervention rate as compared to percutaneous transluminal angioplasty (PTA) alone

Conditions

  • Intermittent Claudication
  • Atherosclerotic Disease
  • Arterial Occlusive Disease

Interventions

OTHER

Percutaneous Transluminal Angioplasty

Balloon Angioplasty

DEVICE

LifeStent NT™ Self-Expanding Peripheral Stent

Balloon angioplasty plus stent

Sponsors & Collaborators

  • CardioVascular Research Foundation, Korea

    collaborator OTHER

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Barry T Katzen, MD · Baptist Cardiac & Vascular Institute, Miami, FL

  • John R Laird, MD · Vascular Center at the University of California, Davis Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2006-08-31
Completion
2010-10-31

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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 NCT00673985 on ClinicalTrials.gov