Clinical trial NCT00886899: Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)
Official title: Facilitated Antegrade Steering Technique in Chronic Total Occlusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Chronic Total Occlusion
Keywords: CTO
chronic total occlusion
CAD
coronary artery disease
interventional cardiology
revascularization
recanalization
Lead sponsor: BridgePoint Medical
Sponsor class: INDUSTRY
First posted: 2009-04-23
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 for comparison. Enrollment of up to 149 subjects with a CTO refractory to currently marketed guidewire use and meeting all inclusion/exclusion criteria at up to 15 US clinical sites. Hypothesis is that the BridgePoint Medical System is safe and effective in treating coronary CTOs compared to CTO literature.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Technical Success
timeFrame: Intraprocedural
measure: 30-day Major Adverse Cardiac Event (MACE) Rate
timeFrame: 30 Days
Secondary outcomes:
measure: Total Procedure Time
timeFrame: Intraprocedural
measure: Total Procedural Fluoroscopy Time
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Luke's Medical Center
state: Arizona
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Sacramento
country: United States
facility: University of California Davis Heart & Vascular Center
state: California
city: Stanford
country: United States
facility: Stanford University Hospital
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Springfield
country: United States
facility: Prairie Cardiovascular Consultants
state: Illinois
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute, Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - St. Mary's Hospital
state: Minnesota
city: Kansas City
country: United States
facility: Mid America Heart Institute, St. Luke's Hospital
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Bellingham
country: United States
facility: St. Joseph Hospital
state: Washington
Study officials:
affiliation: The Cleveland Clinic
name: Patrick Whitlow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Whitlow PL, Burke MN, Lombardi WL, Wyman RM, Moses JW, Brilakis ES, Heuser RR, Rihal CS, Lansky AJ, Thompson CA; FAST-CTOs Trial Investigators. Use of a novel crossing and re-entry system in coronary chronic total occlusions that have failed standard crossing techniques: results of the FAST-CTOs (Facilitated Antegrade Steering Technique in Chronic Total Occlusions) trial. JACC Cardiovasc Interv. 2012 Apr;5(4):393-401. doi: 10.1016/j.jcin.2012.01.014.