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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00504088
Other study ID # FHT-P-06-003
Secondary ID
Status Terminated
Phase Phase 4
First received July 17, 2007
Last updated August 19, 2008
Start date October 2006

Study information

Verified date August 2007
Source FoxHollow Technologies
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Ischemic rest pain for more than 2 weeks or ulceration or gangrene of the foot or toes (Rutherford Becker Category 4, 5 or 6)

- Willing and able, as evaluated by the PI, to provide Informed Consent

- Willing to undergo up to 5 years of clinical follow up visits as scheduled

- Angiographic pattern of infrainguinal disease that can be reasonably managed either by surgery or plaque excision in the first instance

- Reconstitution of at least one patent target tibial segment below the knee which provides run-off to the foot

- The patient must be >18 years of age

- Target lesion(s) is located at or below the level of the superficial femoral artery

- Target lesion(s) is >50% stenosed by quantitative vascular angiography

- Ability to take at least one of the following types of medications: anti- platelet or anti-thrombotic therapy

Exclusion Criteria:

- Patient has cardiac or cardiovascular comorbidities that would make surgery inappropriate

- Patient has terminal or Stage 4 cancer

- Patient has extensive gangrene that requires both a Below-the-Knee amputation and a revascularization procedure

- Previous stent in the target lesion

- Active infection at planned incision site

- The patient is a pregnant woman

- The patient has significant suprainguinal or Common Femoral disease that can not be treated either prior to or during the index procedure

- Target Lesion is a Chronic Total Occlusion (CTO) that is greater than 15cm in length and has severe, continuous calcification

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Bypass

Silverhawk Plaque Excision


Locations

Country Name City State
United States New Mexico Heart Institute, PA Albuquerque New Mexico
United States Vascular Surgery Associates Baton Rouge Louisiana
United States University of Alabama, Birmingham Birmingham Alabama
United States Beth Isreal (BIDMC) Boston Massachusetts
United States University of Chicago Chicago Illinois
United States Cleveland VAMC Cleveland Ohio
United States Iowa Methodist Medical Center Des Moines Iowa
United States Duke University Medical Center Durham North Carolina
United States Heart & Vascular Clinic of Northern Colorado Fort Collins Colorado
United States Hackensack University Medical Center Hackensack New Jersey
United States St. Vincent Indianapolis Indiana
United States University of Mississippi Jackson Mississippi
United States Los Angeles Cardiology/Good Samaritan Los Angeles California
United States Holmes Regional Medical Center Melbourne Florida
United States Vanderbilt University Medical Center Nashville Tennessee
United States Columbia Presbyterian New York New York
United States NY Weill Cornell Medical Center New York New York
United States St. Vincent's Medical Center New York New York
United States Sentara Heart Hospital Norfolk Virginia
United States Advocate Christ Medical Center Oak Lawn Illinois
United States Alegent Health Research Center Omaha Nebraska
United States Sacred Heart Hospital Pensacola Florida
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Rhode Island Hospital Providence Rhode Island
United States William Beaumont/Southeast Surgical Royal Oak Michigan
United States UC Davis Vascular Center Sacramento California
United States San Francisco VA Medical Center San Francisco California
United States Providence Hospital Southfield Michigan
United States Stanford University Medical Center/Palo Alto VA Stanford California
United States Madigan Army Medical Center Tacoma Washington
United States St. Vincent Hospital Worchester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
FoxHollow Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major amputation-free survival
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