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Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia (PROOF)

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ClinicalTrials.gov Identifier: NCT00504088
Recruitment Status : Terminated (Company decision to halt study)
First Posted : July 19, 2007
Last Update Posted : August 20, 2008
Information provided by:
FoxHollow Technologies

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

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Study Type : Interventional  (Clinical Trial)
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 : October 2006

Primary Outcome Measures :
  1. Major amputation-free survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504088

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Sponsors and Collaborators
FoxHollow Technologies
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Principal Investigator: James F. McKinsey, M.D. Columbia University
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ClinicalTrials.gov Identifier: NCT00504088    
Other Study ID Numbers: FHT-P-06-003
First Posted: July 19, 2007    Key Record Dates
Last Update Posted: August 20, 2008
Last Verified: August 2007
Keywords provided by FoxHollow Technologies:
Critical Limb Ischemia
Peripheral Arterial Disease
Leg Pain
Peripheral Bypass
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases