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 @ 3:43 PM
Ignite Modification Date:
2025-12-24 @ 3:43 PM
NCT ID:
NCT03820492
Eligibility Criteria:
Inclusion Criteria:
* Unprotected LM lesion \[midshaft, and distal bifurcation (Medina 1,1,1 or 1,1,0 or 1,0,1 or 1,0,0)\] of 30% to 80% angiographic diameter stenosis (DS) on visual estimation or equivocal disease by angiography.
* Age ≥18 years.
* Ability to give preliminary oral consent witnessed by an independent physician or sign written informed consent prior to any study-specific procedures.
Exclusion Criteria:
* Significant distal lesions (\>50% angiographic DS on visual estimation within the left anterior descending artery \[LAD\] or left circumflex artery \[LCX\], except for ostium of LAD or LCX or diseased side branch \[e.g. diagonal branch, obtuse marginal branch\])
* Ostial LM disease.
* Acute coronary syndrome (ACS) (non-ST-elevation ACS and ST-elevation MI).
* LM In-stent restenosis.
* Previous coronary stenting of the left coronary system.
* Chronic total occlusion.
* Previous coronary artery bypass graft.
* Previous MI related to the left coronary artery.
* Occurrence of ventricularization or hypotension during engagement of the LM ostial lesion.
* The presence of hemodynamic instability.
* Known renal insufficiency (serum creatinine \>1.5mg/dL or receiving dialysis).
* Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
* Life expectancy less than 1 year.
* Contraindication or known allergy against protocol-required medications including heparin, iodinated contrast, β-blocker, nitroglycerin, and adenosine.
* Body mass index \>35kg/m2.
* Complex congenital heart disease other than anomalous coronary origins alone.
* Ventricular septal defect.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03820492
Study Brief:
Protocol Section:
NCT03820492