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

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

This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.

The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.

Inclusion Criteria:

• Adult aged 25-80
• Patient understands and has signed the study informed consent form.
• Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0.
• Suitable candidate for non-emergent, coronary angioplasty
• Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches
• Body Mass Index (BMI) < 40
• Left ventricle ejection fraction > 25%

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