Status:
COMPLETED
Peripheral Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Lead Sponsor:
BridgePoint Medical
Conditions:
Chronic Total Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Study of the BridgePoint Medical System in the crossing of chronic total occlusions of the lower extremities.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT01246505
Start Date
July 1 2011
End Date
January 1 2012
Last Update
July 12 2012
Active Locations (10)
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1
St. Luke's Medical Center
Phoenix, Arizona, United States
2
University of Southern California Medical Center
Los Angeles, California, United States
3
Torrance Memorial Medical Center
Torrance, California, United States
4
University of Colorado Denver
Denver, Colorado, United States