STRATEGY for Left Main Coronary Bifurcation Lesion II

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: One stent technique + Elective FKB; Device: Elective 2-stent; Procedure: Provisional approach; Device: One stent technique alone

• Registration Number: NCT01798433
• Lead Sponsor: Samsung Medical Center

Brief Summary

In patients with unprotected left main (LM) true bifurcation lesion (cohort A), elective 2-stent strategy is superior to provisional strategy at preventing the occurrence of 12-month target lesion failure after percutaneous coronary intervention for bifurcation lesion.

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-25
• Study Start: 2013-03-18
• Primary Completion: 2018-07-31
• Study Completion: 2018-07-31
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-29
• Last Update Posted: 2019-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age ≥20 years
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

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Exclusion Criteria

1. The patient has a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Biolimus
2. Patients who have received DES implantation in the target lesion prior to enrollment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One stent technique + Elective FKB	One stent technique + Elective FKB	One stent technique + Elective FKB for non-true LM bifurcation
Elective 2-stent	Elective 2-stent	Elective 2-stent for true LM bifurcation
Provisional approach	Provisional approach	Provisional approach for true LM bifurcation
One stent technique alone	One stent technique alone	One stent technique alone for non-true LM bifurcation

Primary Outcome Measures

Name	Time	Method
Target lesion failure	12-month	defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Procedure success rate	the first 48 hours after PCI
Cardiac death	12-month	All deaths were considered cardiac unless a definite non-cardiac cause could be established.
Angiographic in-segment restenosis rate	9 months	as measured by 9-month quantitative coronary analysis
Target vessel revascularization (TVR)	12-month	TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery.
Stent thrombosis	12-month	Stent thrombosis was assessed based on the definitions of the Academic Research Consortium as definite, probable, or possible stent thrombosis.
Myocardial infarction (MI)	12-month	MI was defined as elevated cardiac enzymes (troponin or MB fraction of creatine kinase, CK-MB) more than the upper limit of the normal value with ischemic symptoms or electrocardiography findings indicative of ischemia that was not related to the index procedure.
Target lesion revascularization (TLR)	12-month	TLR was defined as repeat PCI of the lesion within 5 mm of stent deployment or bypass graft surgery of the target vessel.
Periprocedural CK-MB elevation	the first 48 hours after PCI	Periprocedural enzyme elevation was defined as a rise in CK-MB ≥3 times the upper normal limit after the index procedure.
Procedure time	immediate after PCI
Amount of contrast dye	immediate after PCI

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of