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Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions (PFAST-CTOs)

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: NCT01246505
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : July 12, 2012
Information provided by (Responsible Party):
BridgePoint Medical

Brief Summary:
Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.

Condition or disease Intervention/treatment Phase
Chronic Total Occlusion Device: CTO Crossing and Percutaneous transluminal angioplasty Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Study Start Date : July 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : January 2012

Intervention Details:
  • Device: CTO Crossing and Percutaneous transluminal angioplasty
    Crossing of the CTO with the BridgePoint Medical System and subsequent treatment of the CTO via PTA (specific devices to be used for PTA at investigators' discretion)

Primary Outcome Measures :
  1. Incidence of Patients with a Major Adverse Events (MAE) [ Time Frame: 30 Day ]
    MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication.

  2. Incidence of Intraprocedural Technical Success [ Time Frame: Intraprocedural (<24 hours) ]
    Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO

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:

  • suitable candidate for non-emergent, peripheral angioplasty
  • documented de-novo or restenotic peripheral CTO lesion with TIMI 0 flow for at least 90 days and satisfactory distal vessel visualization (collateral supply)
  • limb ischemia or claudication, Rutherford class I-III (grade 1-5) caused by the occluded artery

Exclusion Criteria:

  • intolerance to aspirin or a neutropenic response to Ticlopidine or Clopidogrel
  • appearance of thrombus or intraluminal filling defects
  • peripheral intervention in the target limb within two weeks of the procedure
  • renal insufficiency (serum creatinine of > 2.3 mg/dl)
  • contraindication to a peripheral artery intervention
  • participation in another investigational protocol

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 identifier (NCT number): NCT01246505

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United States, Arizona
St. Luke's Medical Center
Phoenix, Arizona, United States
United States, California
University of Southern California Medical Center
Los Angeles, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
United States, Colorado
University of Colorado Denver
Denver, Colorado, United States
United States, Georgia
Emory University Medical Center
Atlanta, Georgia, United States
United States, Illinois
Prairie Cardiovascular Consultants
Springfield, Illinois, United States, 62701
United States, New York
Columbia University Medical Center
New York, New York, United States
United States, North Carolina
Wake Heart Center
Raleigh, North Carolina, United States
United States, Texas
Dallas VA Medical Center
Dallas, Texas, United States
United States, Washington
St. Joseph Hospital
Bellingham, Washington, United States
Sponsors and Collaborators
BridgePoint Medical
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Principal Investigator: William A Gray, MD Columbia University
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Responsible Party: BridgePoint Medical Identifier: NCT01246505    
Other Study ID Numbers: 200-0012
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: July 12, 2012
Last Verified: July 2012