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NCT00512720 Clinical Trial

Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis

Peripheral Artery Disease Clinical Trial

— FIX-IT Retro  

Official title:
Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00512720
Other study ID # 2007-174
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2007
Est. completion date February 2010

Study information
Verified date July 2023
Source Spectrum Health Hospitals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 355
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Patients with Superficial Femoral Artery disease as assessed by angiography

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Spectrum Health Grand Rapids Michigan

Sponsors (2)
Lead Sponsor Collaborator
Spectrum Health Hospitals West Michigan Heart

Country where clinical trial is conducted

United States, 

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