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

NCT ID: NCT00512720

Last Updated: 2023-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

355 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-02-28

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with Superficial Femoral Artery disease as assessed by angiography
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West Michigan Heart

UNKNOWN

Sponsor Role collaborator

Spectrum Health Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jihad Mustapha, MD

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Dennis Dunning, MD

Role: PRINCIPAL_INVESTIGATOR

Spectrum Health Hospitals

Locations

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Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2007-174

Identifier Type: -

Identifier Source: org_study_id

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