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 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 12:53 AM
NCT ID:
NCT05125367
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years or older
2. Angiographically confirmed multivessel coronary artery disease \[critical (\>70%) lesions in at least two major epicardial vessels (≥ 2.0mm in diameter) at least two separate coronary artery territories (the right coronary artery (RCA), left circumflex artery (LCX) and left anterior descending (LAD)\] and are expected to be equally treatable with PCI(Percutaneous Coronary Intervention) or CABG(coronary artery bypass graft) by interventionalists and surgeons at the investigating site.
3. Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia
4. Geographically accessible and willing to come in for required study visits
5. Signed informed consent.
Exclusion Criteria:
1. The patient has a known hypersensitivity or contraindication to any of the following medications:
* Heparin
* Aspirin
* Both Clopidogrel and TIclopidine
* Sirolimus, paclitaxel, ABT 578
* Stainless steel and/or
* Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine \[e.g. rash\] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).
2. Severe congestive heart failure (class III or IV according to New York Heart Association (NYHA) Functional Classification, or pulmonary edema) at the time of enrollment. The degree of left ventricular ejection fraction is not considered as an index of exclusion.
3. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent).
4. Prior CABG surgery
5. Prior PCI with DES implantation within 1 year
6. Two or more chronic total occlusions in major coronary territories
7. Acute ST-elevation myocardial infarction(Q-wave) within 72 hours prior to enrollment requiring revascularization.
8. Abnormal creatine kinase (CK \> 2x normal) and/or abnormal CK-MB levels and/or elevated Troponin levels at time of randomization. When the cardiac enzyme is returned to normal, those can be enrolled.
9. Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement.
10. Extra-cardiac illness that is expected to limit survival to less than 2 years; e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
11. Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES(drug eluting stent) related anticoagulation.
12. Contraindication either CABG or PCI/DES because of a coexisting clinical condition
13. Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
14. Suspected pregnancy.
15. Concurrent enrollment in another clinical trial
16. Left main stenosis (at least 50% diameter stenosis)
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05125367
Study Brief:
Protocol Section:
NCT05125367