Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
NCT ID: NCT01246505
Last Updated: 2012-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
105 participants
INTERVENTIONAL
2011-07-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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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 Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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BridgePoint Medical
INDUSTRY
Responsible Party
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Principal Investigators
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William A Gray, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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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, 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
Countries
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Other Identifiers
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200-0012
Identifier Type: -
Identifier Source: org_study_id