Japan Unprotected Left Main Coronary Artery Disease Percutaneous Coronary Intervention (PCI) Strategy On New Generation Stents

Study Overview
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Brief Summary
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The main purpose of this study is to observe the incidence of major adverse cardiac and cerebrovascular events (MACCE), target vessel failure (TVF), target vessel revascularization (TVR) and stent thrombosis out to 5 years after the procedure in patients who underwent percutaneous coronary intervention (PCI) with everolimus-eluting stents for unprotected left main coronary artery (ULMCA) disease and lesions involving the ULMCA in Japan. The investigators will also establish a method of adjustment to the Japanese version of the SYNTAX score by conducting an assessment using the SYNTAX score recently reported in the US and Europe as well as the EuroSCORE, and by clarifying the differences of PCI procedures and treatment results in Japan with those reported in the US and Europe.

Official Title
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Multicenter Prospective Registry of PCI With a New Generation Everolimus- Eluting Stent for Unprotected Left Main Coronary Artery Disease

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 20 years or older Patients who have signed a written consent Patients who are indicated for percutaneous coronary intervention (PCI) Patients who are considered to be eligible for drug eluting stents Patients who have a de novo lesion to be treated Patients who have ULMCA and lesions involving the ULMCA Patients who can be treated with two of the longest everolimus-eluting stents in one branch Patients who can receive antiplatelet agents for at least 12 months after placement of the drug eluting stent Exclusion Criteria: Patients who can not fully understand the contents of informed consent of this study Patients who can not provide informed consent because of their mental retardation or language disorder Patients who cannot be followed up for 2 years after the completion of the stent placement Patients who had previously received PCI or coronary artery bypass graft (CABG) for left main coronary artery (LMCA) disease Patients who are scheduled to undergo cardiac surgery Patients who are enrolled in an ongoing registry or clinical trial. Except for a post-marketing study (PMS) that will not influence the result of this study In principal, patients who have participated or are scheduled to participate in another clinical trial related to cardiac blood vessels before completion of the 2-year follow-up period of this study Patients who have a life expectancy of less than 3 years because of a concomitant disease at enrollment Patients who are on home oxygen therapy (HOT) Patients with a serious valvular disease Patients who are on dialysis treatment Patients with severe renal dysfunction (serum creatinine ≥ 2.0 mg/dL) Patients with a low left ventricular ejection fraction of less than 30% Patients with acute myocardial infarction or CK (CPK) levels exceeding twice the institutional upper limit of normal Patients with chronic total occlusions (CTO) in the LMCA Patients who are considered to require a protection device Patients who are confirmed to have an allergy or hypersensitivity to everolimus, acrylic polymer, fluoropolymer or cobalt chrome alloy L-605 Patients who have side effects of antiplatelet agents or anticoagulants Nursing women or those of childbearing potential whose pregnancy test conducted within 14 days before the procedure was positive Patients disqualified from participation by the investigator/sub-investigator

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| J-LESSON Central committee<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major adverse cardiac and cerebrovascular events (MACCE) | Incidence of major adverse cardiac and cerebrovascular events (MACCE) at 2 years after the procedure | At 2 years after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of lesions by SYNTAX Score |  | Baseline procedure | 
| Assessment of lesion by EuroSCORE |  | Baseline procedure | 
| Assessment of bifurcation lesion by intravascular ultrasound (IVUS) |  | Baseline procedure | 
| Assessment of bifurcation lesion by intravascular ultrasound (IVUS) |  | At 10 months post-procedure | 
| Assessment of bifurcation lesion by fractional flow reserve (FFR) |  | Baseline procedure | 
| Assessment of bifurcation lesion by fractional flow reserve (FFR) |  | At 10 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting stent (DES), unprotected left main coronary artery (ULMCA)