STRATEGY for Left Main Coronary Bifurcation Lesion II (STRATEGY-II)
|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 ]
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|