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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

November 19, 2010
July 11, 2012
July 2011
December 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01246505 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Total Occlusion
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)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
January 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01246505
200-0012
Yes
BridgePoint Medical
BridgePoint Medical
Not Provided
Principal Investigator: William A Gray, MD Columbia University
BridgePoint Medical
July 2012

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