Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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.
- * 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
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No