Comparison of Double-kissing Crush and Double-kissing Culotte Stenting

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Double-kissing Crush and Double-kissing Culotte Stenting in Patients With True Bifurcation Lesion

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: double kissing crush stenting
* Procedure: double kissing culotte stenting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| double kissing crush stenting<br>patients with true bifurcation lesion undergoing double kissing crush stenting | Procedure: double kissing crush stenting<br>* Patients with true bifurcation lesion treating with double kissing crsuh stenting technique<br>|
| double kissing culotte stenting<br>patients with true bifurcation lesion undergoing double kissing culotte stenting | Procedure: double kissing culotte stenting<br>* Patients with true bifurcation lesion treating with double kissing culotte stenting technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (major adverse cardiovascular events) | target vessel revascularization, myocardial infarction and cardiac death | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCEs (major adverse cerebral and cardiovascular events) | all cause death, myocardial infarction, target lesion revascularization, target lesion revascularization, in-stent thrombosis and/or restenosis, stroke | 12, 24, 36 months | 
| target lesion failure | myocardial infarction, cardiac death | 24, 36 months |