Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

Peripheral Vascular Diseases Clinical Trial

— PROOF  

Official title:

Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00504088
• Other study ID #: FHT-P-06-003
• 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
• 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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

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