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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:
ClinicalTrials.gov Identifier:
NCT00512720
First Posted: August 8, 2007
Last Update Posted: February 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
West Michigan Heart
Information provided by:
Spectrum Health Hospitals
  Purpose
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

Condition
Peripheral Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis

Further study details as provided by Spectrum Health Hospitals:

Biospecimen Retention:   Samples With DNA
blood

Enrollment: 355
Study Start Date: August 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
male and female over the age of 18 who have had Three Different Percutaneous Revascularization Strategies
Criteria

Inclusion Criteria:

  • Patients with Superficial Femoral Artery disease as assessed by angiography
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512720


Locations
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49503
Sponsors and Collaborators
Spectrum Health Hospitals
West Michigan Heart
Investigators
Principal Investigator: Jihad Mustapha, MD Spectrum Health Hospitals
Principal Investigator: Dennis Dunning, MD Spectrum Health Hospitals
  More Information

Additional Information:
Responsible Party: Jihad Mustapha, MD, Spectrum Health
ClinicalTrials.gov Identifier: NCT00512720     History of Changes
Other Study ID Numbers: 2007-174
First Submitted: August 7, 2007
First Posted: August 8, 2007
Last Update Posted: February 21, 2013
Last Verified: February 2013

Keywords provided by Spectrum Health Hospitals:
PAD
Peripheral Artery Disease
PVD
Peripheral Vascular Disease
Leg Blockage
Angioplasty
Stent
Claudication

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases