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

Study Overview
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Brief Summary
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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.

Official Title
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Facilitated Antegrade Steering Technique in Chronic Total Occlusions

Conditions
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Coronary Artery Chronic Total Occlusion

Intervention / Treatment
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* Device: Recanalization of a coronary chronic total occlusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BridgePoint Medical System<br>Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire | Device: Recanalization of a coronary chronic total occlusion<br>* Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement<br>* Other names: Stingray Guidewire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Procedure Time | Minus any time to determine CTO was refractory to standard guidewire | Intraprocedural | 
| Total Procedural Fluoroscopy Time | Minus any time to determine CTO was refractory to standard guidewire | Intraprocedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTO, chronic total occlusion, CAD, coronary artery disease, interventional cardiology, revascularization, recanalization