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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT02284750
Eligibility Criteria:
Inclusion Criteria:
* Provision of informed consent prior to any study specific procedures;
* Men and women 18 years and older;.
* Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology;
* Native coronary lesion suitable for drug-eluting stent placement;
* True bifurcation lesions (Medina 0,1,1/1,1,1);
* Reference vessel diameter in side branch ≥2.5mm by visual estimation;
* Complex bifurcation lesions based on DEFINITION study.
Exclusion Criteria:
* Pregnancy and breast feeding mother;
* Co-morbidity with an estimated life expectancy of \< 50 % at 12 months;
* Scheduled major surgery in the next 12 months;
* Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk;
* Unable to provide written informed consent, or fail to follow the protocol;
* Previous enrolment in coronary intervention device investigation during the study period;
* Patient with STEMI within 24-hour from the onset of chest pain to admission;
* Restenosis bifurcation lesions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02284750
Study Brief:
Protocol Section:
NCT02284750