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:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-26 @ 5:23 PM
NCT ID:
NCT05952206
Eligibility Criteria:
Inclusion Criteria:
* Age \>18 - \< 95 years;
* Presence of one or more coronary artery stenosis of 50% or more in a native coronary artery or in a saphenous venous or arterial bypass conduit suitable for coronary stent implantation. The vessel should have a reference vessel diameter of at least 2.00 mm (no limitation on the number of treated lesions, vessels, or lesion length);
* Able to provide informed consent and willing to participate in the trial.
Exclusion Criteria:
* Known intolerance to acetylsalicylic acid, P2Y12 inhibitors (clopidogrel, prasugrel, or ticagrelor), sirolimus, everolimus, or chromium-cobalt.;
* Known severe hepatic impairment Child-Pug stage C;
* Prior PCI (not related to the study) performed in the last 45 days;
* Planned non-cardiac surgery during the first month after PCI, unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
* Planned coronary artery bypass graft (CABG) or any other cardiac surgery (valvular for instance) following index PCI;
* Active major bleeding or major surgery within the last 30 days;
* Known stroke (any type) within the 30 days prior to the randomization;
* Women of childbearing potential being defined as woman from the onset of menstruation (menarche) until they become postmenopausal, unless they are permanently sterile. A postmenopausal state is clarified as having no menstrual periods for 12 consecutive months without any other medical cause. Women who have undergone permanent sterilization methods, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy, can be enrolled in the study
* Currently participating in another randomized controlled trial and not yet at its primary endpoint;
* Life expectancy less than one year due to non-cardiovascular comorbidity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
95 Years
Study:
NCT05952206
Study Brief:
Protocol Section:
NCT05952206