Facilitated Antegrade Steering Technique in Chronic Total Occlusions (FAST-CTOs)
Condition: Coronary Artery Chronic Total Occlusion
Intervention: Recanalization of a coronary chronic total occlusion
Intervention description: Crossing a CTO to allow definitive treatment via balloon angioplasty and/or stent placement
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CTO; chronic total occlusion; CAD; coronary artery disease; interventional cardiology; revascularization; recanalization

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.
    

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