Status:
COMPLETED
Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)
Lead Sponsor:
BridgePoint Medical
Conditions:
Coronary Artery Chronic Total Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Prospective, non-randomized, multicenter study in subjects with coronary artery chronic total occlusions (CTOs). Published results of safety and effectiveness of conventional techniques will be used f...
Eligibility Criteria
Inclusion
- suitable candidate for non-emergent, coronary angioplasty
- documented coronary CTO lesion with the following characteristics: a) Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days; b) satisfactory distal vessel visualization; and c) refractory to currently marketed guidewire crossing via 1 of the following: 1. previous failed attempt to cross CTO within the past 12 months; or 2. unsuccessful CTO crossing w/ guidewire (10-15 min fluoro time); or 3. attempt to cross CTO w/ guidewire results in subintimal guidewire
- angina or ischemia caused by the occluded artery
- at least 18 years of age
- Body Mass Index (BMI) \< 40
- left ventricle ejection fraction \> 20%
- sign the Informed Consent Form
Exclusion
- saphenous vein graft (SVG) CTO or an in-stent CTO
- aorto-ostial CTO location. (Ostial bifurcation origins may be considered)
- intolerance to aspirin or a neutropenic response to Ticlopidine/Clopidogrel
- appearance of thrombus or intraluminal filling defects
- severe cerebrovascular disease (history of stroke or TIA within 1 month)
- cardiac intervention within two weeks of the procedure
- renal insufficiency (serum creatinine of \> 2.3 mg/dl)
- active gastrointestinal bleeding
- active infection or fever that may be due to infection
- life expectancy \< 2 years due to other illnesses
- significant anemia (hemoglobin \< 8.0 mg / dl)
- severe uncontrolled systemic hypertension
- severe electrolyte imbalance
- anaphylaxis to angiographic contrast media unless appropriately medicated
- congestive heart failure \[New York Heart Association (NYHA) Class IV\]
- unstable angina requiring emergent percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
- recent myocardial infarction (MI)(within the past two weeks)
- uncontrolled diabetes
- participation in another investigational protocol
- unwillingness or inability to comply with any protocol requirements
- pregnant or nursing
- extensive dissection from refractory guidewire use
- crossing CTO (true lumen) w/ guidewire within 10-15 min of fluoro time
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00886899
Start Date
March 1 2009
End Date
September 1 2010
Last Update
March 20 2012
Active Locations (16)
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1
St. Luke's Medical Center
Phoenix, Arizona, United States, 85006
2
Scripps Clinic
La Jolla, California, United States, 92037
3
University of California Davis Heart & Vascular Center
Sacramento, California, United States, 95817
4
Stanford University Hospital
Stanford, California, United States, 94305