Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)
FAST-CTOs
1 other identifier
interventional
147
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2009
Shorter than P25 for phase_2
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 21, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedResults Posted
Study results publicly available
March 13, 2012
CompletedMarch 20, 2012
March 1, 2012
1.4 years
April 21, 2009
February 21, 2012
March 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Technical Success
Defined as the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a chronic total occlusion (CTO) in the true vessel lumen in cases that were otherwise refractory to treatment with a currently marketed guidewire
Intraprocedural
30-day Major Adverse Cardiac Event (MACE) Rate
Defined as cardiac death, Q-wave and non-Q-wave \[total creatinine kinase (CK) \>2x upper limit of normal with a positive myocardial band (MB) fraction\] myocardial infarction (MI), target lesion revascularization (TLR), and emergency bypass surgery.
30 Days
Secondary Outcomes (2)
Total Procedure Time
Intraprocedural
Total Procedural Fluoroscopy Time
Intraprocedural
Study Arms (1)
BridgePoint Medical System
EXPERIMENTALAttempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
Interventions
Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 \[New York Heart Association (NYHA) Class IV\]
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
St. Luke's Medical Center
Phoenix, Arizona, 85006, United States
Scripps Clinic
La Jolla, California, 92037, United States
University of California Davis Heart & Vascular Center
Sacramento, California, 95817, United States
Stanford University Hospital
Stanford, California, 94305, United States
Torrance Memorial Medical Center
Torrance, California, 90505, United States
Yale-New Haven Hospital
New Haven, Connecticut, 06520, United States
Prairie Cardiovascular Consultants
Springfield, Illinois, 62701, United States
Minneapolis Heart Institute, Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mayo Clinic - St. Mary's Hospital
Rochester, Minnesota, 55905, United States
Mid America Heart Institute, St. Luke's Hospital
Kansas City, Missouri, 64111, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Columbia University Medical Center
New York, New York, 10032, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Dallas VA Medical Center
Dallas, Texas, 75216, United States
Intermountain Medical Center
Murray, Utah, 84157, United States
St. Joseph Hospital
Bellingham, Washington, 98225, United States
Related Publications (1)
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.
PMID: 22516395DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- VP, Clinical Affairs
- Organization
- BridgePoint Medical
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Whitlow, MD
The Cleveland Clinic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2009
First Posted
April 23, 2009
Study Start
March 1, 2009
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
March 20, 2012
Results First Posted
March 13, 2012
Record last verified: 2012-03