Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Jihad Mustapha, MD, Spectrum Health
ClinicalTrials.gov Identifier: NCT00512720     History of Changes
Other Study ID Numbers: 2007-174
Study First Received: August 7, 2007
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

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
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014