The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique

Study Overview
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Brief Summary
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In this COMPLETE randomized trial, using the contemporary second-generation drug-eluting stent, we aimed to test whether the crush technique is superior to the culotte technique for the treatment of bifurcation lesions in terms of 1-year target-lesion failure.

Official Title
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The COMPLETE Treatment of Bifurcation With Two-stent Techniques: Randomized Comparison of Crush Versus Culotte Technique

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Crush technique
* Device: Culotte technique


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age ≥19 years De novo coronary lesions eligible for drug-eluting stent implantation Medina 1,1,1 or 1,0,1 or 0,1,1 de novo bifurcation lesions (LM or non-LM) and those of main vessel or side branch can be covered by 2 stents Reference vessel diameter of side branch ≥2.5 mm by visual estimation Exclusion criteria Current or potential pregnancy Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator Subjects with ST elevation myocardial infarction <24 h from the onset of chest pain Cardiogenic Shock

Ages Eligible for Study
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Minimum Age: 19 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crush technique group<br>Two stenting with the Crush technique | Device: Crush technique<br>* Treatment for bifurcation with the Crush technique<br>|
| Active Comparator: Culotte technique group<br>Two stenting with the Culotte technique | Device: Culotte technique<br>* Treatment for bifurcation with the culotte technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | The composite of cardiovascular death, target vessel myocardial infarction or clinically driven target lesion revascularization | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death | Death resulting from cardiovascular causes. | 1 year | 
| Target vessel myocardial infarction | The definition of myocardial infarction followed the fourth universal definition of myocardial infarction and The Academic Research Consortium-2 Consensus Document. | 1 year | 
| Clinically driven target-lesion revascularization | a repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. | 1 year | 
| All-cause of death |  | 1 year | 
| Target-vessel or non-target vessel myocardial infarction | The definition of myocardial infarction followed the fourth universal definition of myocardial infarction and The Academic Research Consortium-2 Consensus Document. | 1 year | 
| Definite or probable stent thrombosis | Stent thrombosis is defined according to the Academic Research Consortium definition | 1 year |