UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004759
Receipt number R000005665
Scientific Title Japan Unprotected Left Main Coronary artery Disease PCI Strategy On New Generation Stents
Date of disclosure of the study information 2010/12/20
Last modified on 2019/03/04 18:18:54

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Basic information

Public title

Japan Unprotected Left Main Coronary artery Disease PCI Strategy
On New Generation Stents

Acronym

Japan Unprotected Left Main Coronary artery Disease PCI Strategy
On New Generation Stents (J-LESSON)

Scientific Title

Japan Unprotected Left Main Coronary artery Disease PCI Strategy
On New Generation Stents

Scientific Title:Acronym

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

1st name
Middle name
Last name Masato Nakamura, M.D.

Organization

Toho University Ohashi Medical Center

Division name

Division of Cardiovasular Medicine

Zip code


Address

2-17-6, Ohashi Meguro-ku, Tokyo

TEL

0354086430

Email

Teruhisa.Kiguchi@aeeijapan.org


Public contact

Name of contact person

1st name
Middle name
Last name Teruhisa Kiguchi

Organization

J-LESSON Support Center

Division name

AEEI

Zip code


Address

AEEI

TEL

0354086430

Homepage URL

https://www.j-lesson.jp/

Email

Teruhisa.Kiguchi@aeeijapan.org


Sponsor or person

Institute

Non-profit organization Associations for Establishment of Evidence Interventions

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 11 Month 19 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005665


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name