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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

Tracking Information
First Submitted Date  ICMJE July 17, 2007
First Posted Date  ICMJE July 19, 2007
Last Update Posted Date August 20, 2008
Study Start Date  ICMJE October 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July¬†17,¬†2007)
Major amputation-free survival
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
Official Title  ICMJE Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia
Brief Summary To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Vascular Diseases
Intervention  ICMJE
  • Procedure: Bypass
  • Procedure: Silverhawk Plaque Excision
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00504088
Other Study ID Numbers  ICMJE FHT-P-06-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE FoxHollow Technologies
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James F. McKinsey, M.D. Columbia University
PRS Account FoxHollow Technologies
Verification Date August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP