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

BridgePoint Medical

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Chronic Total Occlusion

Treatments: Device: Recanalization of a coronary chronic total occlusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT00886899

200-0002

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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147 participants in 1 patient group

BridgePoint Medical System

Experimental group

Description:

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

Treatment:

Device: Recanalization of a coronary chronic total occlusion