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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)

S

Spectrum Health Hospitals

Status

Completed

Conditions

Peripheral Artery Disease

Study type

Observational

Funder types

Other

Identifiers

NCT00512720
2007-174

Details and patient eligibility

About

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

Full 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.

Enrollment

355 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Patients with Superficial Femoral Artery disease as assessed by angiography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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