Clinical trial NCT00504088: Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
Official title: Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Peripheral Vascular Diseases
Keywords: CLI
Critical Limb Ischemia
PAD
Peripheral Arterial Disease
Artherosclerosis
Leg Pain
Cardiovascular
Artherectomy
Bypass
Peripheral Bypass
PROOF
Lead sponsor: FoxHollow Technologies
Sponsor class: INDUSTRY
First posted: 2007-07-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Major amputation-free survival
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Los Angeles Cardiology/Good Samaritan
state: California
city: Sacramento
country: United States
facility: UC Davis Vascular Center
state: California
city: San Francisco
country: United States
facility: San Francisco VA Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center/Palo Alto VA
state: California
city: Fort Collins
country: United States
facility: Heart & Vascular Clinic of Northern Colorado
state: Colorado
city: Melbourne
country: United States
facility: Holmes Regional Medical Center
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent
state: Indiana
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Baton Rouge
country: United States
facility: Vascular Surgery Associates
state: Louisiana
city: Boston
country: United States
facility: Beth Isreal (BIDMC)
state: Massachusetts
city: Worchester
country: United States
facility: St. Vincent Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont/Southeast Surgical
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Omaha
country: United States
facility: Alegent Health Research Center
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Heart Institute, PA
state: New Mexico
city: New York
country: United States
facility: St. Vincent's Medical Center
state: New York
city: New York
country: United States
facility: NY Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Columbia Presbyterian
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland VAMC
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Norfolk
country: United States
facility: Sentara Heart Hospital
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Columbia University
name: James F. McKinsey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: