Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience (NCT01574586) | Clinical Trial Compass
UnknownNot Applicable
Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience
Japan240 participantsStarted 2012-04
Plain-language summary
The primary objective of this study is to make a comparison of safety and efficacy of DESs with different link number (2-link Nobori and 3-link Xience) in patients with de novo true bifurcation lesions.
The minimum lumen diameter of the side branch ostium in bifurcation at 8 months and the MACE rate until one year after PCI will be assessed in both groups.
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
. Patient eligible for percutaneous coronary intervention
. Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence
. De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%)
. Second vessel at coronary bifurcation treatable with trial device during the procedure
. True coronary bifurcation, ≥50% diameter stenosis in both the main and side branches, belonging to the Medina classes 1.1.1, 1.0.1, and 0.1.1,
. Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, ≥2.25 mm in the side branch
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
Minimum lumen diameter of the side branch ostium in bifurcation