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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COMPLETED
NA
200 participants
INTERVENTIONAL
2013-03-18
2018-07-31
Brief Summary
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In patients with unprotected LM non-true bifurcation lesion (cohort B), 1-stent technique with mandatory final kissing ballooning is superior to 1-stent technique without kissing ballooning at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.
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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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One stent technique alone
One stent technique alone for non-true LM bifurcation
One stent technique alone
One stent technique alone with drug-eluting stent
One stent technique + Elective FKB
One stent technique + Elective FKB for non-true LM bifurcation
One stent technique + Elective FKB
One stent technique + Elective FKB with drug-eluting stents + balloon
Provisional approach
Provisional approach for true LM bifurcation
Provisional approach
Provisional approach with drung-eluting stents
Elective 2-stent
Elective 2-stent for true LM bifurcation
Elective 2-stent
Elective 2-stent with drug-eluting stents
Interventions
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One stent technique alone
One stent technique alone with drug-eluting stent
One stent technique + Elective FKB
One stent technique + Elective FKB with drug-eluting stents + balloon
Provisional approach
Provisional approach with drung-eluting stents
Elective 2-stent
Elective 2-stent with drug-eluting stents
Eligibility Criteria
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Inclusion Criteria
2. Left main bifurcation lesion on coronary angiography
3. Significant myocardial ischemia Main vessel (left main coronary artery and left anterior descending artery) and/or side branch (left circumflex artery) diameter stenosis \> 75%, or diameter stenosis 50-75% with angina and/or objective evidence of ischemia in the non-invasive stress test
4. Significant size of the main branch (left anterior descending artery) and side branch (left cirmflex artery) - The reference diameter of both branches ≥ 2.5 mm by visual estimation
Exclusion Criteria
2. Patients who have received DES implantation in the target lesion prior to enrollment
20 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Hyeon-Cheol Gwon
Professor
Principal Investigators
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Hyeon-Cheol Gwon, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2012-12-039
Identifier Type: -
Identifier Source: org_study_id
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