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

NCT ID: NCT00886899

Last Updated: 2012-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-09-30

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.

Conditions

Coronary Artery Chronic Total Occlusion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BridgePoint Medical System

Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire

Group Type: EXPERIMENTAL

Recanalization of a coronary chronic total occlusion

Intervention Type: DEVICE

Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement

Interventions

Recanalization of a coronary chronic total occlusion

Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement

Intervention Type: DEVICE

Other Intervention Names

CrossBoss Catheter; Stingray Catheter; Stingray Guidewire

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BridgePoint Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Whitlow, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

St. Luke's Medical Center

Phoenix, Arizona, United States

Scripps Clinic

La Jolla, California, United States

University of California Davis Heart & Vascular Center

Sacramento, California, United States

Stanford University Hospital

Stanford, California, United States

Torrance Memorial Medical Center

Torrance, California, United States

Yale-New Haven Hospital

New Haven, Connecticut, United States

Prairie Cardiovascular Consultants

Springfield, Illinois, United States

Minneapolis Heart Institute, Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Mayo Clinic - St. Mary's Hospital

Rochester, Minnesota, United States

Mid America Heart Institute, St. Luke's Hospital

Kansas City, Missouri, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Columbia University Medical Center

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Dallas VA Medical Center

Dallas, Texas, United States

Intermountain Medical Center

Murray, Utah, United States

St. Joseph Hospital

Bellingham, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22516395 (View on PubMed)

Other Identifiers

200-0002

Identifier Type: -

Identifier Source: org_study_id