A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter

To be filled later

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 with the following characteristics:

• Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days;
• Satisfactory distal vessel visualization
• CTO should be amenable to percutaneous treatment and must be located in a coronary vessel with a reference diameter of at least 2 millimeters.
• CTO refractory to a minimum of 10 minutes of conventional guide wire attempt.
• Body Mass Index (BMI) < 40
• Left ventricle ejection fraction > 25%

For the purpose of this trial, a CTO is defined as a 100% luminal narrowing without antegrade flow or with antegrade or retrograde filling through collateral vessels.

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Exclusion criteria

• 1. Patient unable to give informed consent. 2. Current participation in another study with any investigational drug or device.

• Patient is known or suspected not to tolerate the contrast agent. 4. Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO and in-stent CTOs.

• Intolerance to aspirin or Clopidogrel or Prasugrel or Ticagrelor medications 6. Appearance of a fresh thrombus or intraluminal filling defects. 7. Recent major cerebrovascular event (history of stroke or TIA within 1 month) 8. Cardiac intervention within 4 weeks of the procedure 9. Renal insufficiency (serum creatinine of > 2.3mg/dl) 10. Active gastrointestinal bleeding 11. Active infection or fever that may be due to infection 12. Life expectancy < 2 years due to other illnesses 13. Significant anemia (hemoglobin < 8.0 mg / dl) 14. Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure )

• Severe electrolyte imbalance 16. 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) 18. Recent myocardial infarction (MI) (within the past two weeks) 19. Uncontrolled diabetes >2 serum glucose concentrations of >350 mg/dl within 7 days.

• Participation in another investigational protocol 21. Unwillingness or inability to comply with any protocol requirements 22. Pregnant or nursing 23. Extensive prior dissection from a coronary guidewire use 24. Drug abuse or alcoholism. 25. Patients under custodial care. 26. Bleeding diathesis or coagulation disorder; 27. Kawasaki's disease or other vasculitis.