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

This study has been terminated.
(Company decision to halt study)
Information provided by:
FoxHollow Technologies Identifier:
First received: July 17, 2007
Last updated: August 19, 2008
Last verified: August 2007
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs

Condition Intervention Phase
Peripheral Vascular Diseases Procedure: Bypass Procedure: Silverhawk Plaque Excision Phase 4

Study Type: Interventional
Study Design: 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

Further study details as provided by FoxHollow Technologies:

Primary Outcome Measures:
  • Major amputation-free survival

Study Start Date: October 2006

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00504088

  Show 31 Study Locations
Sponsors and Collaborators
FoxHollow Technologies
Principal Investigator: James F. McKinsey, M.D. Columbia University
  More Information Identifier: NCT00504088     History of Changes
Other Study ID Numbers: FHT-P-06-003
Study First Received: July 17, 2007
Last Updated: August 19, 2008

Keywords provided by FoxHollow Technologies:
Critical Limb Ischemia
Peripheral Arterial Disease
Leg Pain
Peripheral Bypass

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases processed this record on August 18, 2017