Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor Associations for Establishment of Evidence in Interventions
Start date October 2010
End date May 2015
Trial size 750 participants
Trial identifier NCT01256723, J-LESSON2.0

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm

Primary Outcomes

Measure
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
time frame: At 2 years after the procedure

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title Multicenter Prospective Registry of PCI With a New Generation Everolimus- Eluting Stent for Unprotected Left Main Coronary Artery Disease
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Associations for Establishment of Evidence in Interventions.