Status:
UNKNOWN
Japan Unprotected Left Main Coronary Artery Disease Percutaneous Coronary Intervention (PCI) Strategy On New Generation Stents
Lead Sponsor:
Associations for Establishment of Evidence in Interventions
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20+ years
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 thr...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Patients who are considered to require a protection device
- Patients who are confirmed to have an allergy or hypersensitivity to everolimus, acrylic polymer, fluoropolymer or cobalt chrome alloy L-605
- Patients who have side effects of antiplatelet agents or anticoagulants
- Nursing women or those of childbearing potential whose pregnancy test conducted within 14 days before the procedure was positive
- Patients disqualified from participation by the investigator/sub-investigator
Key Trial Info
Start Date :
October 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2018
Estimated Enrollment :
441 Patients enrolled
Trial Details
Trial ID
NCT01256723
Start Date
October 1 2010
End Date
May 1 2018
Last Update
January 27 2017
Active Locations (1)
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1
Non-profit organization Associations for Establishment of Evidence in Interventions
Hamamatsuchō, Tokyo, Japan, 105-0013