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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)
Sponsor:
Information provided by:
FoxHollow Technologies
ClinicalTrials.gov Identifier:
NCT00504088
First received: July 17, 2007
Last updated: August 19, 2008
Last verified: August 2007
  Purpose

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: Open Label
Primary Purpose: Treatment
Official Title: Plaque Removal Versus Open Bypass Surgery For Critical Limb Ischemia

Resource links provided by NLM:


Further study details as provided by FoxHollow Technologies:

Primary Outcome Measures:
  • Major amputation-free survival

Study Start Date: October 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504088

  Show 31 Study Locations
Sponsors and Collaborators
FoxHollow Technologies
Investigators
Principal Investigator: James F. McKinsey, M.D. Columbia University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00504088     History of Changes
Other Study ID Numbers: FHT-P-06-003
Study First Received: July 17, 2007
Last Updated: August 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by FoxHollow Technologies:
CLI
Critical Limb Ischemia
PAD
Peripheral Arterial Disease
Artherosclerosis
Leg Pain
Cardiovascular
Artherectomy
Bypass
Peripheral Bypass
PROOF

Additional relevant MeSH terms:
Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014