Japan Unprotected Left Main Coronary Artery Disease Percutaneous Coronary Intervention (PCI) Stra… (NCT01256723) | Clinical Trial Compass
UnknownNot Applicable
Japan Unprotected Left Main Coronary Artery Disease Percutaneous Coronary Intervention (PCI) Strategy On New Generation Stents
Japan441 participantsStarted 2010-10
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Timeframe: At 2 years after the procedure
Trial details
NCT IDNCT01256723
SponsorAssociations for Establishment of Evidence in Interventions
✕. 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