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Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)

NCT00883246 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2019-06-04

Study results available
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Summary

The purpose of the study is to evaluate the intermediate and long-term effectiveness of stand-alone atherectomy treatment of peripheral arterial disease in the legs.

Conditions

  • Peripheral Arterial Disease
  • Claudication
  • Critical Limb Ischemia

Interventions

DEVICE

SilverHawk & TurboHawk Peripheral Plaque Excision System

Removal of atherosclerotic plaque from artery walls.

Sponsors & Collaborators

  • Medtronic Endovascular

    lead INDUSTRY

Principal Investigators

  • Lawrence Garcia, MD · St. Elizabeth's Medical Center, Tuft's University School of Medicine

  • James McKinsey, MD · The New York Presbyterian/Columbia University

  • Professor Thomas Zeller · Herz-Zentrum Bad Krozingen Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-06-30
Completion
2012-06-30

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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 NCT00883246 on ClinicalTrials.gov