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 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT03714750
Eligibility Criteria:
Inclusion Criteria:
Patients must meet all of the inclusion criteria:
* Documented heart team (as per guidelines) decision for revascularization via PCI
* Planned percutaneous coronary intervention (PCI) for a bifurcation stenosis with both branches \>2.5mm and with a stenosis \>50% and clinical indication to percutaneous intervention, including:
* Ischemic symptoms, OR
* Positive non-invasive imaging for ischemia, OR
* Positive Flow Fractional Reserve (FFR), OR
* mean lumen area (MLA) \<6mm\^2 for the left main or \<4mm\^2 for epicardial vessels as assessed by intracoronary imaging (IVUS, OCT)
* Vessel diameter ≤5.00mm
* True bifurcation lesion type 1,1,1 or 0,1,1
* Patient ≥18 years old
Exclusion Criteria:
* Cardiogenic shock
* Trifurcation if all vessels are ≥2.75mm diameter
* Either bifurcation vessel not suitable for stenting
* History of stenting in target bifurcation lesion
* Participation in another investigational drug or device study
* Patient unable to give informed consent
* Women of child-bearing potential or lactating
* In-stent restenosis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03714750
Study Brief:
Protocol Section:
NCT03714750