Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions

Study Overview
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Brief Summary
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The purpose of this study is to establish the optimal strategy for stenting in coronary bifurcation lesion.

Detailed Description
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The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of two-stenting and simple stenting techniques in patients with complex bifurcation lesions. Based on the previous studies, the rate of 1-year target lesion failure events was around 14% after PCI with provisional stenting. And our previous data showed that this event at 12-month after two-stenting procedure was 7%. Considering the lost to follow-up, it is anticipated that up to 660 patients will be enrolled in the trial. All patients will have repeat angiography at 13 months, with clinical follow-up to 5 years.

Official Title
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A Prospective, Multi-center, Randomized Trial Comparing Two-stent With Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Percutaneous coronary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures; Men and women 18 years and older;. Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology; Native coronary lesion suitable for drug-eluting stent placement; True bifurcation lesions (Medina 0,1,1/1,1,1); Reference vessel diameter in side branch ≥2.5mm by visual estimation; Complex bifurcation lesions based on DEFINITION study. Exclusion Criteria: Pregnancy and breast feeding mother; Co-morbidity with an estimated life expectancy of < 50 % at 12 months; Scheduled major surgery in the next 12 months; Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; Unable to provide written informed consent, or fail to follow the protocol; Previous enrolment in coronary intervention device investigation during the study period; Patient with STEMI within 24-hour from the onset of chest pain to admission; Restenosis bifurcation lesions.

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two-stenting technique<br>Percutaneous coronary intervention with DK crush, or culotte technique | Procedure: Percutaneous coronary intervention<br> <br> * Other names: PCI;|
| Active Comparator: Provisional stenting technique<br>Percutaneous coronary intervention with Provisional stenting technique. Stenting of the side branch was required if TIMI flow was <3, or ≥ type B dissection after kissing balloon inflation. | Procedure: Percutaneous coronary intervention<br> <br> * Other names: PCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death |  | 12 months | 
| Target-vessel myocardial infarction |  | 12 months | 
| Target lesion revascularisation |  | 12 months | 
| Target vessel revascularisation |  | 12 months | 
| Stent thrombosis |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bifurcation lesion, Percutaneous coronary intervention