Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs) - Full Text View

Sponsored by:	BridgePoint Medical
Information provided by:	BridgePoint Medical
ClinicalTrials.gov Identifier:	NCT00886899

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Chronic Total Occlusion	Device: Recanalization of a coronary chronic total occlusion	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Further study details as provided by BridgePoint Medical:

Primary Outcome Measures:

Technical Success: defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a CTO in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]
30-day MACE rate: defined as cardiac death, Q-wave and non-Q-wave (total CK >2x upper limit of normal with a positive MB fraction) myocardial infarction, target lesion revascularization, and emergency bypass surgery. [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Total Procedure Time [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]
Total Procedural Fluoroscopy Time [ Time Frame: Intraprocedural ] [ Designated as safety issue: No ]

Estimated Enrollment:	149
Study Start Date:	March 2009
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
BridgePoint Medical System: Experimental Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire (10-15 minutes of fluoroscopy time)	Device: Recanalization of a coronary chronic total occlusion Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

suitable candidate for non-emergent, coronary angioplasty
documented coronary CTO lesion with the following characteristics: a) 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 (NYHA Class IV)
unstable angina requiring emergent PTCA or CABG
recent 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886899

Locations

United States, Arizona
St. Luke's Medical Center
Phoenix, Arizona, United States, 85006
United States, California
Torrance Memorial Medical Center
Torrance, California, United States, 90505
Scripps Clinic
La Jolla, California, United States, 92037
University of California Davis Heart & Vascular Center
Sacramento, California, United States, 95817
Stanford University Hospital
Stanford, California, United States, 94305
United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06520
United States, Florida
Baptist Hospital of Miami
Miami, Florida, United States, 33176
United States, Minnesota
Minneapolis Heart Institute, Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic - St. Mary's Hospital
Rochester, Minnesota, United States, 55905
United States, Missouri
St. Luke's Hospital
Kansas City, Missouri, United States, 64111
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
United States, Washington
St. Joseph Hospital
Bellingham, Washington, United States, 98225

Sponsors and Collaborators

BridgePoint Medical

Investigators

Principal Investigator:

Patrick Whitlow, MD

Cleveland Clinic

More Information

No publications provided

Responsible Party:	BridgePoint Medical ( John Schultz, Vice President, Clinical Affairs )
Study ID Numbers:	200-0002
Study First Received:	April 21, 2009
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00886899 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by BridgePoint Medical:

CTO
chronic total occlusion
CAD
coronary artery disease

interventional cardiology
revascularization
recanalization

Study placed in the following topic categories:

Coronary Disease
Coronary Artery Disease

ClinicalTrials.gov processed this record on May 06, 2009