Japan Unprotected Left Main Coronary Artery Disease Percutaneous Coronary Intervention (PCI) Stra… (NCT01256723) | Clinical Trial Compass
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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 range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 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