Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT01131793
Eligibility Criteria:
Inclusion Criteria:
* Patient eligible for elective revascularization of a native coronary vessel
* Patient has refractory coronary total occlusion (Thrombolysis In Myocardial Infarction (TIMI) 0 flow) within a stent
* Written Informed Consent obtained
Exclusion Criteria:
* Under 18 years of age
* Current participation in another study with any investigational drug or device
-\>TIMI 0 flow at target lesion site
* Lesion \>40mm. in length
* Factors making follow-up or repeat angiography difficult or unlikely
* Acute myocardial infarction less than 1 month before angioplasty
* Contra-indication to emergency coronary artery bypass surgery
* No access to cardiac surgery
* Contra-indication to treatment with aspirin, ticlopidine, clopidogrel or heparin
* Angiographic evidence of thrombus (filling defect proximal to or involving the occlusion)
* Occluded ostium of the right coronary artery or stem of left main coronary artery as target lesion
* Totally occluded bypass graft as target vessel
* Occlusion in an unprotected left main coronary artery
* Ejection fraction less than 30%
* Lesion beyond acute bends or in a location within the coronary anatomy where the catheter cannot traverse
* Lesion within a bifurcation with a significant sidebranch \>1.5mm in diameter
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01131793
Study Brief:
Protocol Section:
NCT01131793