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

Coronary Artery Disease Clinical Trial

— J-LESSON  

Official title:

Multicenter Prospective Registry of PCI With a New Generation Everolimus- Eluting Stent for Unprotected Left Main Coronary Artery Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01256723
• Other study ID #: J-LESSON2.0
• Status: Active, not recruiting
• Phase: N/A
• First received: November 30, 2010
• Last updated: January 26, 2017
• Start date: October 2010
• Est. completion date: May 2018

Study information

• Verified date: January 2017
• Source: Associations for Establishment of Evidence in Interventions
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 441
• Est. completion date: May 2018
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Japan	Non-profit organization Associations for Establishment of Evidence in Interventions	Hamamatsu-cho	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Associations for Establishment of Evidence in Interventions

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major adverse cardiac and cerebrovascular events (MACCE)	Incidence of major adverse cardiac and cerebrovascular events (MACCE) at 2 years after the procedure	At 2 years after the procedure
Secondary	Assessment of lesions by SYNTAX Score		Baseline procedure
Secondary	Assessment of lesion by EuroSCORE		Baseline procedure
Secondary	Assessment of bifurcation lesion by intravascular ultrasound (IVUS)		Baseline procedure
Secondary	Assessment of bifurcation lesion by intravascular ultrasound (IVUS)		At 10 months post-procedure
Secondary	Assessment of bifurcation lesion by fractional flow reserve (FFR)		Baseline procedure
Secondary	Assessment of bifurcation lesion by fractional flow reserve (FFR)		At 10 months post-procedure