Safety and Efficacy of the CiTop™ Guidewire for Crossing Chronic Total Occlusions in Coronary Arteries

Inclusion criteria

• Informed consent obtained prior to any trial activities.
• Patients, male or female between 21 and 80 years of age, with no significant co-morbidities (see exclusion criteria).
• Patient has an angiographic documented Chronic Total Occlusion showing distal TIMI flow 0 to 1.

Exclusion criteria

• Patient unable to give informed consent.
• Current participation in another study with any investigational drug or device.
• Factors making follow-up and/or repeat angiography difficult or unlikely.
• Contra-indication to emergency artery by pass surgery.
• Lack of surgical backup.
• Contra-indication to treatment with Aspirin, or Clopidogrel and/or Heparin.
• Lesion > 40mm in length (both calcified lesion and adjacent thrombus).
• Treated vessel referenced diameter less than 2.5 mm.
• Visualization of the distal lumen less than the Rentrop Classification Grade 2 collateralization.
• Non-visible entry point of target lesion.
• Totally occluded bypass graft as target vessel.
• Acute MI less than 1 week before procedure.
• Patient has significant LV dysfunction, 35% LVEF or less.
• Patient with cancer or other sever chronic disease with life expectance of 2 years.
• Patient has chronic renal failure with serum creatinine ≥2.
• Hemoglobin ≤11.
• Patient is known or suspected not to tolerate the contrast agent.
• Morbid Obesity (BMI > 40).
• Drug abuse or alcoholism.
• Patients under custodial care.
• Pregnant women or women with childbearing potential with a positive pregnancy test at the time of procedure.