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Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis (FIX-IT Retro)

This study has been completed.
Sponsor:
Collaborator:
West Michigan Heart
Information provided by:
Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT00512720
First received: August 7, 2007
Last updated: February 20, 2013
Last verified: February 2013

August 7, 2007
February 20, 2013
August 2007
February 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00512720 on ClinicalTrials.gov Archive Site
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Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis
Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis

To determine the effect of three different percutaneous revascularization strategies (Balloon Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower extremity claudication

Endovascular revascularization of the superficial femoral artery (SFA) has become one of the most commonly performed endovascular procedures.The ability to offer the patient an alternative to surgical revascularization, limited by significant morbidity and mortality, with a same-day outpatient percutaneous procedure underlies the popularity of the endovascular approach. Although surgical bypass of the SFA remains the gold standard for revascularization, it is associated with significant morbidity and mortality.Comparative data between cryoplasty, angioplasty or stenting of the SFA will ultimately be required to provide more robust evidence of the efficacy of each mode of therapy.This registry is designed to determine the efficacy of three different percutaneous revascularization strategies (Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower extremity claudication.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Retention:   Samples With DNA
Description:

blood

Probability Sample

male and female over the age of 18 who have had Three Different Percutaneous Revascularization Strategies

Peripheral Artery Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
355
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with Superficial Femoral Artery disease as assessed by angiography
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00512720
2007-174
No
Jihad Mustapha, MD, Spectrum Health
Spectrum Health Hospitals
West Michigan Heart
Principal Investigator: Jihad Mustapha, MD Spectrum Health Hospitals
Principal Investigator: Dennis Dunning, MD Spectrum Health Hospitals
Spectrum Health Hospitals
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP