A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions

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

This is an open label, single-center, prospective, pivotal study in which the investigational device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo CTO-PCI using an anterograde approach.

Inclusion Criteria:

• Adult aged 25-80
• Patient understands and has signed the study informed consent form.
• Patient is a suitable candidate for non-emergent, coronary angioplasty
• Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration either by documentation or PI assessment Investigator) showing distal TIMI flow 0.
• Coronary angiography of CTO lesion reveals satisfactory distal vessel visualization
• CTO lesion is located in a coronary vessel with a reference diameter of at least 2 millimeters.
• CTO lesion is suitable for antegrade approach.
• Left ventricle ejection fraction > 25%
• Body Mass Index (BMI) < 40

Exclusion Criteria:

• Patient unable to give informed consent.
• Patient is participating in another study with any investigational drug or device.
• Patient is known or suspected not to tolerate the contrast agent.
• Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG 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 (stroke or TIA within 30 days)
• Significant anemia (hemoglobin < 8.0 mg / dl)
• 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)
• Unwillingness or inability to comply with any protocol requirements
• Pregnancy or nursing