True bifurcation lesions (TBLs) are not rare clinical conditions and may be associated with adverse cardiovascular outcomes due to their complex anatomy and the variety of interventional therapy. Although the provisional stenting is still effective in suitable lesions, double stent techniques can be required in selected patients. In previous studies, double kissing crush (DK-crush) stenting was revealed as superior to provisional stenting in TBL of left main coronary artery. Additionally, in recent studies, double kissing approach facilitates and highlights double kissing culotte (DK-culotte) stenting with lower stent malapposition compared to DK-crush stenting. However, to the best of our knowledge, there is no study about comparing DK-crush and DK-culotte stenting in TBLs. Our aim in this study is to compare DK-crush and DK-culotte stenting in patients with TBL.
Who can participate
Age range
18 Years – 90 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:
* Patients with de novo true bifurcation lesion (Medina classification 1,1,1 or 0,1,1 or 1,0,1)
* The main vessel diameter is least 2.5 mm and the side branch diameter is at least 2.25 mm
Exclusion Criteria:
* Patients presenting with ST segment elevation myocardial infarction, cardiogenic shock and Killip class III-IV heart failure
* Patients with a history of coronary artery bypass grafting surgery
* Patients with a chronic total occlusion in the bifurcation area
* Lesions with severe calcification that needs additional intervention such as atherectomy
* Patients who are not suitable to use long term dual antiplatelet therapy and patients not participating in clinical follow-up
* Patients with hematological disorders, malignancy, end stage renal (GFR\<30 ml/min) and hepatic failure
* Patients with active bleeding
* Pregnant women
* Patients with life-expectancy \< 1 year
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
MACE (major adverse cardiovascular events)
Timeframe: 12 months
Trial details
NCT IDNCT04789161
SponsorIstanbul Mehmet Akif Ersoy Educational and Training Hospital