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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT04242134
Eligibility Criteria:
Inclusion Criteria:
1. Subject must be age ≥18 years.
2. Subject has silent ischemia, or stable/unstable angina, or acute MI older than 1-week from the onset of chest pain to admission.
3. Subject (or legal guardian) understands the trial design and treatment procedures and provides written informal consent before any trial-specific tests or procedures are performed.
4. Subject is willing to comply with all protocol-required follow-up evaluations.
5. Target lesion must be a true bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, or Medina 1,1,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI).
6. Target lesion reference vessel diameter (both main vessel and side branch) ≥ 2.5 mm by visual estimation.
7. Target lesion must have visually estimated stenosis ≥50%.
8. Target lesion length of side branch must be \<10 mm by visual estimation.
9. Ostium side branch must have visually estimated stenosis ≥70% after stenting of the main vessel.
Exclusion Criteria:
1. Patient with STEMI (within 1-week from the onset of chest pain to admission).
2. Patient has known allergy to the study balloon/stent system or protocol-required concomitant medications.
3. Patient is intolerable to dual anti-platelet therapy.
4. Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.
5. Patient is pregnant or nursing.
6. Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
7. Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
8. Restenotic lesion.
9. Chronic total occlusion (CTO) lesion in either main vessel or side branch is not successfully recanalized.
10. Severe calcification needing rotational atherectomy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04242134
Study Brief:
Protocol Section:
NCT04242134