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 ≥ 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
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/
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
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
