Bifurcation Stenting Using 2 Link Stent Nobori Versus 3 Link Stent Xience
NCT ID: NCT01574586
Last Updated: 2015-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
240 participants
INTERVENTIONAL
2012-04-30
2015-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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2-link stent Nobori
Bifurcation stenting
Bifurcation stenting
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience
3-link stent Xience
Bifurcation stenting
Bifurcation stenting
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience
Interventions
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Bifurcation stenting
Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience
Eligibility Criteria
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Inclusion Criteria
2. Patient or substitute decision-maker willing to provide written informed consent, which is approved by the Institutional Review Board or its equivalence
3. De novo stenosis at coronary bifurcation with up to two vessels (visually estimated diameter stenosis ≥50%)
4. Second vessel at coronary bifurcation treatable with trial device during the procedure
5. 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,
6. Visually estimated target lesion reference vessel diameter, 2.5-5.0 mm in the main branch, ≥2.25 mm in the side branch
7. Target lesion treatable with one or two stents in both the main and side branches
8. Consensus of PCI after discussion between cardiologists and cardiac surgeons for the lesion in the left main coronary artery
9. Thrombolysis in Myocardial Infarction grade ≥1 flow in both the main and side branches
Exclusion Criteria
1. Unable to be followed by the implementing medial institution
2. Life expectancy \<1 year
3. Acute myocardial infarction (\<1 week)
4. Left ventricular ejection fraction \<30%
5. Scheduled for elective treatment requiring antiplatelet drug Withdrawal
6. Deemed as unsuitable by the investigator or subinvestigator
7. Serum creatinine level ≥2.0 Mg/dl
B. Vascular morphological restrictions
1. Lesion proximal to coronary artery bypass graft anastomotic site (visual estimation ≤5.0 mm) or including a part of coronary artery bypass grafting
2. In-stent restenosis
3. Severe calcification
20 Years
ALL
No
Sponsors
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Kurashiki Central Hospital
OTHER
Responsible Party
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Locations
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Kurashiki Central Hospital
Kurashiki, , Japan
Countries
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Other Identifiers
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BEGIN12
Identifier Type: -
Identifier Source: org_study_id
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