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

Tracking Information
First Submitted Date  ICMJE November 19, 2010
First Posted Date  ICMJE November 23, 2010
Last Update Posted Date July 12, 2012
Study Start Date  ICMJE July 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2010)
  • 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.
  • 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
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 Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Official Title  ICMJE Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Brief Summary Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Total Occlusion
Intervention  ICMJE 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)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2012)
105
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2010)
50
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT01246505
Other Study ID Numbers  ICMJE 200-0012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party BridgePoint Medical
Study Sponsor  ICMJE BridgePoint Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William A Gray, MD Columbia University
PRS Account BridgePoint Medical
Verification Date July 2012

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