STRATEGY for Left Main Coronary Bifurcation Lesion II (STRATEGY-II)
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|ClinicalTrials.gov Identifier: NCT01798433|
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : January 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: One stent technique alone Device: One stent technique + Elective FKB Procedure: Provisional approach Device: Elective 2-stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi-center, Randomized Study to Evaluate the Optimal Strategy for Side Branch Treatment in Patients With Left Main Coronary Bifurcation Lesion|
|Actual Study Start Date :||March 18, 2013|
|Actual Primary Completion Date :||July 31, 2018|
|Actual Study Completion Date :||July 31, 2018|
Experimental: One stent technique alone
One stent technique alone for non-true LM bifurcation
Device: One stent technique alone
One stent technique alone with drug-eluting stent
Experimental: One stent technique + Elective FKB
One stent technique + Elective FKB for non-true LM bifurcation
Device: One stent technique + Elective FKB
One stent technique + Elective FKB with drug-eluting stents + balloon
Experimental: Provisional approach
Provisional approach for true LM bifurcation
Procedure: Provisional approach
Provisional approach with drung-eluting stents
Experimental: Elective 2-stent
Elective 2-stent for true LM bifurcation
Device: Elective 2-stent
Elective 2-stent with drug-eluting stents
- Target lesion failure [ Time Frame: 12-month ]defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization
- Cardiac death [ Time Frame: 12-month ]All deaths were considered cardiac unless a definite non-cardiac cause could be established.
- Angiographic in-segment restenosis rate [ Time Frame: 9 months ]as measured by 9-month quantitative coronary analysis
- Target vessel revascularization (TVR) [ Time Frame: 12-month ]TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery.
- Stent thrombosis [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 success rate [ Time Frame: the first 48 hours after PCI ]
- Procedure time [ Time Frame: immediate after PCI ]
- Amount of contrast dye [ Time Frame: immediate after PCI ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798433
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Hyeon-Cheol Gwon, MD,PhD||Samsung Medical Center|