The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Stable angina pectoris, unstable angina pectoris, clinically stable non-STEMI.
* Age ≥18 yrs.
* Abel to provide written Informed consent and willing to comply with the specified follow-up contacts.
Angiographic inclusion criteria:
* Native coronary bifurcation de novo lesion
* More than 50% diameter stenosis in the main vessel (MV)
* More than 50% diameter stenosis in the side branch (SB) within 5 mm of the ostium.
* Reference size at least 2.75 mm in the main vessel (MV) and ≥2.5 mm in the SB.
Functional inclusion criteria:
Functional significance of the main vessel lesion or documented ischemia of the main vessel territory or other objective documentation of lesion significance. Objective evidence of ischemia is required for all treated lesions except for lesions with more than 80% diameter stenosis that may be considered significant.
Procedural inclusion criteria:
Indication for two-stent technique or one-stent technique with kissing balloon inflation
Exclusion Criteria:
* STEMI within 72 hours
* Cardiogenic shock
* Prior coronary artery bypass grafting (CABG) or planned CABG
* Renal failure with glomerular filtration rate (GFR) \<50 mL/min per 1.73 m2
* Active bleeding or coagulopathy
* Life expectancy \< 2 years
* Ejection fraction \< 30%
* New York Heart Association (NYHA) class \> II
* Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus).
Angiographic exclusion criteria:
* Severe tortuosity around target…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Combined endpoint of major adverse cardiac events (MACE)