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

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