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

NCT01256723 | Unknown DMC

• 1 other identifier: J-LESSON2.0
• Study Type: observational
• Target: 441
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

drug eluting stent (DES); unprotected left main coronary artery (ULMCA)

Outcome Measures

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

  At 2 years after the procedure

Secondary Outcomes (6)

• Assessment of lesions by SYNTAX Score

  Baseline procedure

• Assessment of lesion by EuroSCORE

  Baseline procedure

• Assessment of bifurcation lesion by intravascular ultrasound (IVUS)

  Baseline procedure

• Assessment of bifurcation lesion by intravascular ultrasound (IVUS)

  At 10 months post-procedure

• Assessment of bifurcation lesion by fractional flow reserve (FFR)

  Baseline procedure

Study Arms (1)

J-LESSON Central committee

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Associations for Establishment of Evidence in Interventions: lead

Study Sites (1)

Non-profit organization Associations for Establishment of Evidence in Interventions

Hamamatsuchō, Tokyo, 105-0013, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Masato Nakamura, M.D

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 9, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2018
• Last Updated: January 27, 2017

Record last verified: 2017-01

Locations

JP (1)