Coronary Artery DiseaseJ-LESSONNCT01256723
Japan Unprotected Left Main Coronary Artery Disease Percutaneous Coronary Intervention (PCI) Strategy On New Generation Stents
An observational study of Coronary Artery Disease, run by Associations for Establishment of Evidence in Interventions at 1 site in Japan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 441 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2010to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The left coronary artery superintendence part change to a morbid state is possessed, and it is a patient for whom the PCI treatment is necessary.
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Non-profit organization Associations for Establishment of Evidence in Interventions
Hamamatsuchō, Tokyo, 105-0013
About this study
Official title: Multicenter Prospective Registry of PCI With a New Generation Everolimus- Eluting Stent for Unprotected Left Main Coronary Artery Disease
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.
- Conditions
- Coronary Artery Disease
- Keywords
- drug eluting stent (DES), unprotected left main coronary artery (ULMCA)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| J-LESSON Central committee | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Incidence of major adverse cardiac and cerebrovascular events (MACCE) at 2 years after the procedure
Measured: At 2 years after the procedure
Secondary outcomes (6)
Assessment of lesions by SYNTAX Score
Measured: Baseline procedure
Assessment of lesion by EuroSCORE
Measured: Baseline procedure
Assessment of bifurcation lesion by intravascular ultrasound (IVUS)
Measured: Baseline procedure
Assessment of bifurcation lesion by intravascular ultrasound (IVUS)
Measured: At 10 months post-procedure
Assessment of bifurcation lesion by fractional flow reserve (FFR)
Measured: Baseline procedure
Assessment of bifurcation lesion by fractional flow reserve (FFR)
Measured: At 10 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2015
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associations for Establishment of Evidence in Interventions
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Masato Nakamura, M.D, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256723
- Sponsor's protocol ID
- J-LESSON2.0
- Acronym
- J-LESSON
- Status last verified
- Jan 2017
- First submitted
- 30 Nov 2010
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Registry of PCI With a New Generation Everolimus- Eluting Stent for Unprotected Left Main Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01256723
- Acronym / sponsor ID
- J-LESSON / J-LESSON2.0
- Conditions
- Coronary Artery Disease
- Keywords
- drug eluting stent (DES), unprotected left main coronary artery (ULMCA)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Associations for Establishment of Evidence in InterventionsUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- May 2015 (actual)
- Study completion
- May 2018 (estimated)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| J-LESSON Central committee | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The left coronary artery superintendence part change to a morbid state is possessed, and it is a patient for whom the PCI treatment is necessary.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Time frame: At 2 years after the procedure
Incidence of major adverse cardiac and cerebrovascular events (MACCE) at 2 years after the procedure
6 secondary outcomes
Assessment of lesions by SYNTAX Score
Time frame: Baseline procedure
Assessment of lesion by EuroSCORE
Time frame: Baseline procedure
Assessment of bifurcation lesion by intravascular ultrasound (IVUS)
Time frame: Baseline procedure
Assessment of bifurcation lesion by intravascular ultrasound (IVUS)
Time frame: At 10 months post-procedure
Assessment of bifurcation lesion by fractional flow reserve (FFR)
Time frame: Baseline procedure
Assessment of bifurcation lesion by fractional flow reserve (FFR)
Time frame: At 10 months post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masato Nakamura, M.D study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Associations for Establishment of Evidence in Interventions at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiac and cerebrovascular events (MACCE) (time frame: At 2 years after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.