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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT03474432
Eligibility Criteria:
Inclusion criteria:
* Age 18 years or greater;
* Left Main CAD, defined as ≥ 50% diameter stenosis and amenable to re-vascularization by PCI;
* Willing and able to give informed consent. The patients must be able to comply with study procedures and follow-up.
* Ability to comply with minimum of 6 months of DAPT after the index procedure.
* Unprotected Left Main PCI
* Protected Left Main PCI
Exclusion criteria:
* Coexisting conditions that limit life expectancy to less than 12 months or that could affect patient's compliance with the protocol;
* Serum creatinine greater than 2.0 mg/dL;
* Cardiogenic shock;
* STEMI;
* Non-STEMI, if the cardiac troponin is not stable or starting to decline;
* Pregnancy;
* Inability to take dual antiplatelet therapy for 6 months;
* Any target lesion with previously placed stent.
* Patients disqualified for CABG surgery.
* Contraindications for OCT use:
1. Bacteremia or sepsis
2. Major coagulation system abnormalities
3. Severe hemodynamic instability or shock
4. Patients diagnosed with coronary artery spasm
5. Acute renal failure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03474432
Study Brief:
Protocol Section:
NCT03474432