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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Associations for Establishment of Evidence in Interventions
ClinicalTrials.gov Identifier:
NCT01256723
First received: November 30, 2010
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multicenter Prospective Registry of PCI With a New Generation Everolimus- Eluting Stent for Unprotected Left Main Coronary Artery Disease

Further study details as provided by Associations for Establishment of Evidence in Interventions:

Primary Outcome Measures:
  • Incidence of major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: At 2 years after the procedure ] [ Designated as safety issue: Yes ]
    Incidence of major adverse cardiac and cerebrovascular events (MACCE) at 2 years after the procedure


Secondary Outcome Measures:
  • Assessment of lesions by SYNTAX Score [ Time Frame: Baseline procedure ] [ Designated as safety issue: Yes ]
  • Assessment of lesion by EuroSCORE [ Time Frame: Baseline procedure ] [ Designated as safety issue: Yes ]
  • Assessment of bifurcation lesion by intravascular ultrasound (IVUS) [ Time Frame: Baseline procedure ] [ Designated as safety issue: Yes ]
  • Assessment of bifurcation lesion by intravascular ultrasound (IVUS) [ Time Frame: At 10 months post-procedure ] [ Designated as safety issue: Yes ]
  • Assessment of bifurcation lesion by fractional flow reserve (FFR) [ Time Frame: Baseline procedure ] [ Designated as safety issue: Yes ]
  • Assessment of bifurcation lesion by fractional flow reserve (FFR) [ Time Frame: At 10 months post-procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: October 2010
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
J-LESSON Central committee

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256723

Locations
Japan
Non-profit organization Associations for Establishment of Evidence in Interventions
Hamamatsu-cho, Tokyo, Japan, 105-0013
Sponsors and Collaborators
Associations for Establishment of Evidence in Interventions
Investigators
Study Chair: Masato Nakamura, M.D
  More Information

Additional Information:
No publications provided

Responsible Party: Associations for Establishment of Evidence in Interventions
ClinicalTrials.gov Identifier: NCT01256723     History of Changes
Other Study ID Numbers: J-LESSON2.0
Study First Received: November 30, 2010
Last Updated: October 28, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Associations for Establishment of Evidence in Interventions:
drug eluting stent (DES)
unprotected left main coronary artery (ULMCA)

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014