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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01798433
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : January 2, 2019
Sponsor:
Information provided by (Responsible Party):
Hyeon-Cheol Gwon, 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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Target lesion failure [ Time Frame: 12-month ]
    defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization


Secondary Outcome Measures :
  1. Cardiac death [ Time Frame: 12-month ]
    All deaths were considered cardiac unless a definite non-cardiac cause could be established.

  2. Angiographic in-segment restenosis rate [ Time Frame: 9 months ]
    as measured by 9-month quantitative coronary analysis

  3. Target vessel revascularization (TVR) [ Time Frame: 12-month ]
    TVR was defined as repeat revascularization of the target vessel by PCI or bypass graft surgery.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Procedure success rate [ Time Frame: the first 48 hours after PCI ]
  9. Procedure time [ Time Frame: immediate after PCI ]
  10. Amount of contrast dye [ Time Frame: immediate after PCI ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Hyeon-Cheol Gwon, MD,PhD Samsung Medical Center
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Responsible Party: Hyeon-Cheol Gwon, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01798433    
Other Study ID Numbers: 2012-12-039
First Posted: February 25, 2013    Key Record Dates
Last Update Posted: January 2, 2019
Last Verified: December 2018
Keywords provided by Hyeon-Cheol Gwon, Samsung Medical Center:
Angioplasty
Transluminal
Percutaneous Coronary
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases