UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan Unprotected Left Main Coronary artery Disease PCI Strategy On New Generation Stents
Title of the study (Brief title)	Japan Unprotected Left Main Coronary artery Disease PCI Strategy On New Generation Stents (J-LESSON)
Region	Japan

Condition
Condition	Coronary Artery Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of major adverse cardiac and cerebrovascular events (MACCE) at 2 years after the procedure
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients aged 20 years or older 2. Patients who have signed a written consent 3. Patients who are indicated for percutaneous coronary intervention (PCI) 4. Patients who are considered to be eligible for drug eluting stents 5. Patients who have a de novo lesion to be treated 6. Patients who have ULMCA and lesions involving the ULMCA 7. Patients who can be treated with two of the longest everolimus-eluting stents in one branch 8. Patients who can receive antiplatelet agents for at least 12 months after placement of the drug eluting stent
Key exclusion criteria	1. Patients who can not fully understand the contents of informed consent of this study 2. Patients who can not provide informed consent because of their mental retardation or language disorder 3. Patients who cannot be followed up for 2 years after the completion of the stent placement 4. Patients who had previously received PCI or coronary artery bypass graft (CABG) for left main coronary artery (LMCA) disease 5. Patients who are scheduled to undergo cardiac surgery 6. 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 7. 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 8. Patients who have a life expectancy of less than 3 years because of a concomitant disease at enrollment 9. Patients who are on home oxygen therapy (HOT) 10. Patients with a serious valvular disease 11. Patients who are on dialysis treatment 12. Patients with severe renal dysfunction (serum creatinine &#8805; 2.0 mg/dL) 13. Patients with a low left ventricular ejection fraction of less than 30% 14. Patients with acute myocardial infarction or CK (CPK) levels exceeding twice the institutional upper limit of normal 15. Patients with chronic total occlusions (CTO) in the LMCA 16. Patients who are considered to require a protection device 17. Patients who are confirmed to have an allergy or hypersensitivity to everolimus, acrylic polymer, fluoropolymer or cobalt chrome alloy L-605 18. Patients who have side effects of antiplatelet agents or anticoagulants 19. Nursing women or those of childbearing potential whose pregnancy test conducted within 14 days before the procedure was positive 20. Patients disqualified from participation by the investigator/sub-investigator
Target sample size	750

Research contact person
Name of lead principal investigator	Masato Nakamura, M.D.
Organization	Toho University Ohashi Medical Center
Division name	Division of Cardiovasular Medicine
Address	2-17-6, Ohashi Meguro-ku, Tokyo
TEL	0354086430
Email	Teruhisa.Kiguchi@aeeijapan.org

Public contact
Name of contact person	Teruhisa Kiguchi
Organization	J-LESSON Support Center
Division name	AEEI
Address	AEEI
TEL	0354086430
Homepage URL	https://www.j-lesson.jp/
Email	Teruhisa.Kiguchi@aeeijapan.org

Sponsor
Institute	Non-profit organization Associations for Establishment of Evidence Interventions
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01256723
Org. issuing International ID_1	Clinical Trials gov.
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 11 Month 19 Day
Anticipated trial start date	2010 Year 12 Month 01 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 09 Month 30 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective observetional study of PIC with a new generation everolimus-eluting stent for unprotected left main coronary artery disease

Management information
Registered date	2010 Year 12 Month 20 Day
Last modified on	2019 Year 03 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005665