Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
PFAST-CTOs
1 other identifier
interventional
105
1 country
10
Brief Summary
Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2011
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2010
CompletedFirst Posted
Study publicly available on registry
November 23, 2010
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJuly 12, 2012
July 1, 2012
5 months
November 19, 2010
July 11, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of Patients with a Major Adverse Events (MAE)
MAE is defined as death, major unplanned amputation, perforation requiring intervention, or target lesion revascularization due to complication.
30 Day
Incidence of Intraprocedural Technical Success
Technical success is defined as the placement of a guidewire in the true lumen distal to the CTO
Intraprocedural (<24 hours)
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
St. Luke's Medical Center
Phoenix, Arizona, United States
University of Southern California Medical Center
Los Angeles, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
University of Colorado Denver
Denver, Colorado, United States
Emory University Medical Center
Atlanta, Georgia, United States
Prairie Cardiovascular Consultants
Springfield, Illinois, 62701, United States
Columbia University Medical Center
New York, New York, United States
Wake Heart Center
Raleigh, North Carolina, United States
Dallas VA Medical Center
Dallas, Texas, United States
St. Joseph Hospital
Bellingham, Washington, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William A Gray, MD
Columbia University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2010
First Posted
November 23, 2010
Study Start
July 1, 2011
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
July 12, 2012
Record last verified: 2012-07