A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions

Exclusion Criteria

• •Patient unable to give informed consent.
• •Current participation in another study with any investigational drug or device.
• •Patient is known or suspected not to tolerate the contrast agent.
• •Aorta-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent CTO.
• •Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
• •Appearance of a fresh thrombus or intraluminal filling defects.
• •Recent major cerebrovascular event (history of stroke or TIA within 1 month)
• •Cardiac intervention within 4 weeks of the procedure
• •Renal insufficiency (serum creatinine of \> 2.3mg/dl or 203μmol/L)
• •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 (\> 240 mmHg within 1 month of procedure)
• •Severe electrolyte imbalance
• •Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] CSA Class IV.
• •Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
• •Recent myocardial infarction (MI) (within the past two weeks)
• •Uncontrolled diabetes \>2 serum glucose concentrations of \>350 mg/dl within 7 days.
• •Unwillingness or inability to comply with any protocol requirements
• •Pregnant or nursing
• •Extensive prior dissection from a coronary guidewire use
• •Drug abuse or alcoholism.
• •Patients under custodial care.
• •Bleeding diathesis or coagulation disorder;
• •Kawasaki's disease or other vasculitis