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Status unknownNCT01256723J-LESSONUpdated Jan 27, 2017

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

An observational study in Coronary Artery Disease, sponsored by Associations for Establishment of Evidence in Interventions. Status unknown at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-01-27.

Sponsored by Associations for Establishment of Evidence in Interventions · Observational

The sponsor has not verified this record recently (last verified Jan 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
441
Ages
20 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • drug eluting stent (DES)
  • unprotected left main coronary artery (ULMCA)
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 441 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Associations for Establishment of Evidence in Interventions is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

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

Exclusion criteria

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
441 participants (actual)
Patient registry
No

Groups and cohorts

  • J-LESSON Central committee
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What researchers measure

Primary outcomes

  1. Incidence of major adverse cardiac and cerebrovascular events (MACCE)

    Incidence of major adverse cardiac and cerebrovascular events (MACCE) at 2 years after the procedure

    Time frame: At 2 years after the procedure

Secondary outcomes

  1. Assessment of lesions by SYNTAX Score

    Time frame: Baseline procedure

  2. Assessment of lesion by EuroSCORE

    Time frame: Baseline procedure

  3. Assessment of bifurcation lesion by intravascular ultrasound (IVUS)

    Time frame: Baseline procedure

  4. Assessment of bifurcation lesion by intravascular ultrasound (IVUS)

    Time frame: At 10 months post-procedure

  5. Assessment of bifurcation lesion by fractional flow reserve (FFR)

    Time frame: Baseline procedure

  6. Assessment of bifurcation lesion by fractional flow reserve (FFR)

    Time frame: At 10 months post-procedure

07

Study locations

1 site
  • Non-profit organization Associations for Establishment of Evidence in Interventions
    Hamamatsu-cho, Tokyo 105-0013, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01256723
Lead sponsor
Associations for Establishment of Evidence in Interventions
Responsible party
Sponsor
First posted
Dec 9, 2010
Start date
Oct 2010
Primary completion
May 2015
Completion
May 2018 (estimated)
Last update
Jan 27, 2017

Study contacts

Masato Nakamura, M.D
study chair

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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