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

August 19, 2008 updated by: FoxHollow Technologies
To compare the outcome of bypass surgery and plaque excision for treatment of critical limb ischemia in the lower limbs

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Major amputation-free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FoxHollow Technologies

Investigators

  • Principal Investigator: James F. McKinsey, M.D., Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Estimate)

August 20, 2008

Last Update Submitted That Met QC Criteria

August 19, 2008

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHT-P-06-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe