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Trial record 1 of 1 for:    PFAST CTO
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Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions (PFAST-CTOs)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BridgePoint Medical
ClinicalTrials.gov Identifier:
NCT01246505
First received: November 19, 2010
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Total Occlusion
 Device: CTO Crossing and Percutaneous transluminal angioplasty
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Further study details as provided by BridgePoint Medical:

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

  • Incidence of Intraprocedural Technical Success [ Time Frame: Intraprocedural (<24 hours) ] [ Designated as safety issue: No ]
    Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO


Enrollment: 105
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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)
  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246505

Locations
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
Investigators
Principal Investigator: William A Gray, MD Columbia University
  More Information

No publications provided

Responsible Party: BridgePoint Medical
ClinicalTrials.gov Identifier: NCT01246505     History of Changes
Other Study ID Numbers: 200-0012
Study First Received: November 19, 2010
Last Updated: July 11, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 19, 2013