VasoStar Vibrational Guidewire System to Facilitate Crossing Coronary Artery Chronic Total Occlusions

Inclusion Criteria

• Male or female, over 18 years of age, presenting with at least one ischemia inducing lesion in a native coronary artery that is refractory to standard guidewire crossing. Chronic total occlusion (CTO) is defined as 100% coronary blockage for over a 3-month duration documented either by prior catheterization or by clinical evaluation
• Suitable candidate for non-emergent, coronary angioplasty
• Documented de-novo or restenotic coronary chronic total occlusion defined as a lesion with TIMI 0 flow for at least 90 days refractory to conventional guidewire crossing
• Left ventricle ejection fraction > 20% within the last 12 months.
• For antegrade chronic total occlusion procedures, activated clotting time (ACT) should be > 300 sec
• Chronic total occlusion in a non-tortuous arterial segment
• Voluntarily sign a Patient Informed Consent Form specific to the study.
• Physically and mentally willing to comply with all study requirements.

Exclusion Criteria

• Successful target lesion crossing with a conventional wire system prior to enrollment
• Prisoners.
• Pregnancy
• Patient has an active implantable.
• Extensive dissection created by refractory guidewire
• Severe ongoing congestive heart failure (New York Heart Association Class IV symptoms)
• Active infection
• Uncontrolled Hypertension (Systolic blood pressure > 180 mm) at the time of the procedure
• History of severe reaction to contrast media
• Recent myocardial infarction (within 2 weeks)
• In-stent target lesion
• Severe cerebrovascular disease including history of prior stroke or transient ischemic attack within 1 month at the time of the procedure
• Saphenous vein graft (SVG) chronic total occlusion or an in-stent chronic total occlusion
• Short life expectancy due to other illnesses such as cancer or pulmonary, hepatic or renal disease
• Participation in another investigational protocol at the time of the procedure