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 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT05258318
Eligibility Criteria:
Inclusion Criteria:
* Patients between 18-90 years of age.
* Patients who gave written informed consent for participation in the trial.
* Lesions are eligible for percutaneous coronary intervention (PCI).
* Patient has stable/unstable angina or myocardial infarction (MI): all-comers.
* ULMb (Medina 1,1,1) with/without left main ostial/shaft lesions. Downstream lesions in LAD or LCX could be covered by two stents. Severe calcification needing rotational atherectomy, orbital atherectomy or Laser are included.
* Diameter stenosis in LAD/LM and LCX ≥ 50% by visual estimation or minimal luminal area by IVUS in LM ≤6 mm2.
Exclusion Criteria:
* Restenotic lesions.
* Patient was allergic to the study stent or protocol-required concomitant medications.
* Patient is intolerable to dual anti-platelet therapy.
* Patient has any other serious medical illness that may reduce life expectancy to \<12 months.
* Patient is a woman who is pregnant or nursing.
* Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
* Patient is participating in another clinical trial.
* Patients in shock.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05258318
Study Brief:
Protocol Section:
NCT05258318