PROOF: Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

Sponsor

FoxHollow Technologies (Industry)

Overall Status

Terminated

CT.gov ID

NCT00504088

Collaborator

(none)

Locations

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Diseases	Procedure: Bypass Procedure: Silverhawk Plaque Excision	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

Study Start Date :

Oct 1, 2006

Outcome Measures

Primary Outcome Measures

Major amputation-free survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama, Birmingham	Birmingham	Alabama	United States	35294
2	Los Angeles Cardiology/Good Samaritan	Los Angeles	California	United States	90017
3	UC Davis Vascular Center	Sacramento	California	United States	95817
4	San Francisco VA Medical Center	San Francisco	California	United States	94121
5	Stanford University Medical Center/Palo Alto VA	Stanford	California	United States	94306
6	Heart & Vascular Clinic of Northern Colorado	Fort Collins	Colorado	United States	80523
7	Holmes Regional Medical Center	Melbourne	Florida	United States	32901
8	Sacred Heart Hospital	Pensacola	Florida	United States	32504
9	University of Chicago	Chicago	Illinois	United States	60637
10	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
11	St. Vincent	Indianapolis	Indiana	United States	46260
12	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
13	Vascular Surgery Associates	Baton Rouge	Louisiana	United States	70809
14	Beth Isreal (BIDMC)	Boston	Massachusetts	United States	02215
15	St. Vincent Hospital	Worchester	Massachusetts	United States	01608
16	William Beaumont/Southeast Surgical	Royal Oak	Michigan	United States	48073
17	Providence Hospital	Southfield	Michigan	United States	48075
18	University of Mississippi	Jackson	Mississippi	United States	39216
19	Alegent Health Research Center	Omaha	Nebraska	United States	68152
20	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
21	New Mexico Heart Institute, PA	Albuquerque	New Mexico	United States	87102
22	St. Vincent's Medical Center	New York	New York	United States	10011
23	NY Weill Cornell Medical Center	New York	New York	United States	10021
24	Columbia Presbyterian	New York	New York	United States	10604
25	Duke University Medical Center	Durham	North Carolina	United States	27712
26	Cleveland VAMC	Cleveland	Ohio	United States	44106
27	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
28	Rhode Island Hospital	Providence	Rhode Island	United States	02903
29	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
30	Sentara Heart Hospital	Norfolk	Virginia	United States	23507
31	Madigan Army Medical Center	Tacoma	Washington	United States	98431