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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

Tracking Information
First Submitted Date  ICMJE February 11, 2013
First Posted Date  ICMJE February 25, 2013
Last Update Posted Date January 2, 2019
Actual Study Start Date  ICMJE March 18, 2013
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
Target lesion failure [ Time Frame: 12-month ]
defined ad a composite of cardiac death, spontaneous MI or target lesion revascularization
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE STRATEGY for Left Main Coronary Bifurcation Lesion II
Official Title  ICMJE A Prospective, Multi-center, Randomized Study to Evaluate the Optimal Strategy for Side Branch Treatment in Patients With Left Main Coronary Bifurcation Lesion
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Device: One stent technique alone
    One stent technique alone with drug-eluting stent
  • Device: One stent technique + Elective FKB
    One stent technique + Elective FKB with drug-eluting stents + balloon
  • Procedure: Provisional approach
    Provisional approach with drung-eluting stents
  • Device: Elective 2-stent
    Elective 2-stent with drug-eluting stents
Study Arms  ICMJE
  • Experimental: One stent technique alone
    One stent technique alone for non-true LM bifurcation
    Intervention: Device: One stent technique alone
  • Experimental: One stent technique + Elective FKB
    One stent technique + Elective FKB for non-true LM bifurcation
    Intervention: Device: One stent technique + Elective FKB
  • Experimental: Provisional approach
    Provisional approach for true LM bifurcation
    Intervention: Procedure: Provisional approach
  • Experimental: Elective 2-stent
    Elective 2-stent for true LM bifurcation
    Intervention: Device: Elective 2-stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2017)
200
Original Estimated Enrollment  ICMJE
 (submitted: February 21, 2013)
700
Actual Study Completion Date  ICMJE July 31, 2018
Actual Primary Completion Date July 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01798433
Other Study ID Numbers  ICMJE 2012-12-039
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hyeon-Cheol Gwon, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hyeon-Cheol Gwon, MD,PhD Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP