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:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-24 @ 12:57 PM
NCT ID:
NCT00540761
Eligibility Criteria:
Inclusion Criteria:
* Undergoing PCTI for coronary artery disease
* Women with childbearing potential must have a negative pregnancy test within the 7 days prior to study entry
Exclusion Criteria:
* Kidney insufficiency (i.e., GFR\<50ml/min)
* OR pregnancy
* OR participants who have had a ST elevation heart attack will be excluded for at least 72 hours post-heart attack and until cardiac enzymes return to normal. Participants who have had a non-ST elevation heart attack will be excluded if they have evidence of ongoing ischemia, defined as chest pain or new electrocardiogram (ECG) changes in the 12 hours prior to study entry and/or rising creatine kinase (CK) and CK-MB serum enzymes.
* OR high-risk and complex lesions, including tortuous blood vessels and lesions with thrombosis
* OR unprotected left main coronary artery disease
* OR enrolled in another investigational clinical trial within the 6 months prior to study entry
* OR severe peripheral vascular disease
* OR active ischemia
* OR congestive heart failure
* OR prior coronary artery bypass surgery
* OR emergent procedures
* OR inability to return for study follow-up procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00540761
Study Brief:
Protocol Section:
NCT00540761