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The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER) (OCTOBER)

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: NCT03171311
Recruitment Status : Active, not recruiting
First Posted : May 31, 2017
Last Update Posted : June 22, 2023
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital Skejby

Tracking Information
First Submitted Date  ICMJE May 28, 2017
First Posted Date  ICMJE May 31, 2017
Last Update Posted Date June 22, 2023
Actual Study Start Date  ICMJE July 5, 2017
Actual Primary Completion Date March 25, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2023)		 Combined endpoint of major adverse cardiac events (MACE) [ Time Frame: 24 months ]
Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2017)		 Combined endpoint of major adverse cardiovascular events (MACE) [ Time Frame: 24 months ]
cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2023)
  • Study bifurcation oriented composite endpoint [ Time Frame: 1 month ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Study bifurcation oriented composite endpoint [ Time Frame: 12 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Study bifurcation oriented composite endpoint [ Time Frame: 24 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Study bifurcation oriented composite endpoint [ Time Frame: 36 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Study bifurcation oriented composite endpoint [ Time Frame: 48 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Study bifurcation oriented composite endpoint [ Time Frame: 60 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Patient oriented composite endpoint [ Time Frame: 1 month ]
    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
  • Patient oriented composite endpoint [ Time Frame: 12 months ]
    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
  • Patient oriented composite endpoint [ Time Frame: 24 months ]
    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
  • Patient oriented composite endpoint [ Time Frame: 36 months ]
    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
  • Patient oriented composite endpoint [ Time Frame: 48 months ]
    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
  • Patient oriented composite endpoint [ Time Frame: 60 months ]
    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
  • All-cause mortality [ Time Frame: 1 month ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 12 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 24 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 36 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 48 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 60 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 120 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • Cardiac death [ Time Frame: 1 month ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
  • Cardiac death [ Time Frame: 12 months ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
  • Cardiac death [ Time Frame: 24 months ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
  • Cardiac death [ Time Frame: 36 months ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
  • Cardiac death [ Time Frame: 48 months ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
  • Cardiac death [ Time Frame: 60 months ]
    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
  • Myocardial infarction [ Time Frame: 1 month ]
    Procedure and non-procedure related myocardial infarction
  • Myocardial infarction [ Time Frame: 12 months ]
    Procedure and non-procedure related myocardial infarction
  • Myocardial infarction [ Time Frame: 24 months ]
    Procedure and non-procedure related myocardial infarction
  • Myocardial infarction [ Time Frame: 36 months ]
    Procedure and non-procedure related myocardial infarction
  • Myocardial infarction [ Time Frame: 48 months ]
    Procedure and non-procedure related myocardial infarction
  • Myocardial infarction [ Time Frame: 60 months ]
    Procedure and non-procedure related myocardial infarction
  • Stent Thrombosis [ Time Frame: 1 month ]
    Definite, possible or probable
  • Stent Thrombosis [ Time Frame: 12 months ]
    Definite, possible or probable
  • Stent Thrombosis [ Time Frame: 24 months ]
    Definite, possible or probable
  • Stent Thrombosis [ Time Frame: 36 months ]
    Definite, possible or probable
  • Stent Thrombosis [ Time Frame: 48 months ]
    Definite, possible or probable
  • Stent Thrombosis [ Time Frame: 60 months ]
    Definite, possible or probable
  • Target lesion myocardial infarction [ Time Frame: 1 month ]
    Myocardial infarction related to an index treated lesion
  • Target lesion myocardial infarction [ Time Frame: 12 months ]
    Myocardial infarction related to an index treated lesion
  • Target lesion myocardial infarction [ Time Frame: 24 months ]
    Myocardial infarction related to an index treated lesion
  • Target lesion myocardial infarction [ Time Frame: 36 months ]
    Myocardial infarction related to an index treated lesion
  • Target lesion myocardial infarction [ Time Frame: 48 months ]
    Myocardial infarction related to an index treated lesion
  • Target lesion myocardial infarction [ Time Frame: 60 months ]
    Myocardial infarction related to an index treated lesion
  • Target lesion revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI of target lesion
  • Target lesion revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI of target lesion
  • Target lesion revascularisation [ Time Frame: 24 months ]
    Coronary artery bypass grafting or PCI of target lesion
  • Target lesion revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI of target lesion
  • Target lesion revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI of target lesion
  • Target lesion revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI of target lesion
  • Target bifurcation myocardial infarction [ Time Frame: 1 month ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation myocardial infarction [ Time Frame: 12 months ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation myocardial infarction [ Time Frame: 24 months ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation myocardial infarction [ Time Frame: 36 months ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation myocardial infarction [ Time Frame: 48 months ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation myocardial infarction [ Time Frame: 60 months ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI of target bifurcation
  • Target bifurcation revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI of target bifurcation
  • Target bifurcation revascularisation [ Time Frame: 24 months ]
    Coronary artery bypass grafting or PCI of target bifurcation
  • Target bifurcation revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI of target bifurcation
  • Target bifurcation revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI of target bifurcation
  • Target bifurcation revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI of target bifurcation
  • Target vessel revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI of target vessel
  • Target vessel revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI of target vessel
  • Target vessel revascularisation [ Time Frame: 24 months ]
    Coronary artery bypass grafting or PCI of target vessel
  • Target vessel revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI of target vessel
  • Target vessel revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI of target vessel
  • Target vessel revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI of target vessel
  • Any revascularisation [ Time Frame: 1 month ]
    Any repeat revascularization except staged revascularization planned during the index procedure
  • Any revascularisation [ Time Frame: 12 months ]
    Any repeat revascularization except staged revascularization planned during the index procedure
  • Any revascularisation [ Time Frame: 24 months ]
    Any repeat revascularization except staged revascularization planned during the index procedure
  • Any revascularisation [ Time Frame: 36 months ]
    Any repeat revascularization except staged revascularization planned during the index procedure
  • Any revascularisation [ Time Frame: 48 months ]
    Any repeat revascularization except staged revascularization planned during the index procedure
  • Any revascularisation [ Time Frame: 60 months ]
    Any repeat revascularization except staged revascularization planned during the index procedure
  • CCS angina class [ Time Frame: 1 month ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • CCS angina class [ Time Frame: 12 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • CCS angina class [ Time Frame: 24 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • CCS angina class [ Time Frame: 36 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • CCS angina class [ Time Frame: 48 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • CCS angina class [ Time Frame: 60 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • Post-PCI minimal lumen diameter in the stented proximal main vessel segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented proximal main vessel segment
  • Post-PCI minimal lumen diameter in the stented distal main vessel segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel segment
  • Post-PCI minimal lumen diameter in the treated side branch vessel segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment
  • Post-PCI minimal lumen diameter in the proximal main vessel edge segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)
  • Post-PCI minimal lumen diameter in the distal main vessel edge segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)
  • Post-PCI minimal lumen diameter in the side branch vessel edge segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)
  • Post-PCI minimal lumen diameter in the stented bifurcation core segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented bifurcation core segment
  • Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment
  • Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated side branch vessel ostium segment
  • Post-PCI diameter stenosis in the stented proximal main vessel segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented proximal main vessel segment
  • Post-PCI diameter stenosis in the stented distal main vessel segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel segment
  • Post-PCI diameter stenosis in the treated side branch vessel segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment
  • Post-PCI diameter stenosis in the proximal main vessel edge segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)
  • Post-PCI diameter stenosis in the distal main vessel edge segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)
  • Post-PCI diameter stenosis in the side branch vessel edge segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)
  • Post-PCI diameter stenosis in the stented bifurcation core segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented bifurcation core segment
  • Post-PCI diameter stenosis in the stented distal main vessel ostium segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment
  • Post-PCI diameter stenosis in the treated side branch ostium segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated side branch ostium segment
  • Post-PCI minimal lumen diameter in non-bifurcation target stented segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target stented segment
  • Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment (within 5mm fra stent)
  • Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment [ Time Frame: 1 day ]
    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment (within 5mm fra stent)
  • Post-PCI diameter stenosis in non-bifurcation target stented segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target stented segment
  • Post-PCI diameter stenosis in non-bifurcation target proximal edge segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment
  • Post-PCI diameter stenosis in non-bifurcation target distal edge segment [ Time Frame: 1 day ]
    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2017)
  • Study bifurcation oriented composite endpoint of MACE [ Time Frame: 1 month ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Study bifurcation oriented composite endpoint of MACE [ Time Frame: 12 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Study bifurcation oriented composite endpoint of MACE [ Time Frame: 24 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Study bifurcation oriented composite endpoint of MACE [ Time Frame: 36 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Study bifurcation oriented composite endpoint of MACE [ Time Frame: 48 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Study bifurcation oriented composite endpoint of MACE [ Time Frame: 60 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
  • Patient oriented composite endpoint endpoint of MACE [ Time Frame: 1 month ]
    All cause mortality, myocardial infarction, any revascularisation, stroke
  • Patient oriented composite endpoint endpoint of MACE [ Time Frame: 12 months ]
    All cause mortality, myocardial infarction, any revascularisation, stroke
  • Patient oriented composite endpoint endpoint of MACE [ Time Frame: 24 months ]
    All cause mortality, myocardial infarction, any revascularisation, stroke
  • Patient oriented composite endpoint endpoint of MACE [ Time Frame: 36 months ]
    All cause mortality, myocardial infarction, any revascularisation, stroke
  • Patient oriented composite endpoint endpoint of MACE [ Time Frame: 48 months ]
    All cause mortality, myocardial infarction, any revascularisation, stroke
  • Patient oriented composite endpoint endpoint of MACE [ Time Frame: 60 months ]
    All cause mortality, myocardial infarction, any revascularisation, stroke
  • All-cause mortality [ Time Frame: 1 month ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 12 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 24 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 36 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 48 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 60 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • All-cause mortality [ Time Frame: 120 months ]
    Death of any cause including cardiac deaths and non-natural causes of death
  • Cardiac death [ Time Frame: 1 month ]
    Death due to cardiovascular disease
  • Cardiac death [ Time Frame: 12 months ]
    Death due to cardiovascular disease
  • Cardiac death [ Time Frame: 24 months ]
    Death due to cardiovascular disease
  • Cardiac death [ Time Frame: 36 months ]
    Death due to cardiovascular disease
  • Cardiac death [ Time Frame: 48 months ]
    Death due to cardiovascular disease
  • Cardiac death [ Time Frame: 60 months ]
    Death due to cardiovascular disease
  • Myocardial infarction [ Time Frame: 1 month ]
    Procedure and non-procedure related myocardial infarction
  • Myocardial infarction [ Time Frame: 12 months ]
    Procedure and non-procedure related myocardial infarction
  • Myocardial infarction [ Time Frame: 24 months ]
    Procedure and non-procedure related myocardial infarction
  • Myocardial infarction [ Time Frame: 36 months ]
    Procedure and non-procedure related myocardial infarction
  • Myocardial infarction [ Time Frame: 48 months ]
    Procedure and non-procedure related myocardial infarction
  • Myocardial infarction [ Time Frame: 60 months ]
    Procedure and non-procedure related myocardial infarction
  • Stent Thrombosis [ Time Frame: 1 month ]
    Definite, possible or probable
  • Stent Thrombosis [ Time Frame: 12 months ]
    Definite, possible or probable
  • Stent Thrombosis [ Time Frame: 24 months ]
    Definite, possible or probable
  • Stent Thrombosis [ Time Frame: 36 months ]
    Definite, possible or probable
  • Stent Thrombosis [ Time Frame: 48 months ]
    Definite, possible or probable
  • Stent Thrombosis [ Time Frame: 60 months ]
    Definite, possible or probable
  • Target lesion myocardial infarction [ Time Frame: 1 month ]
    Myocardial infarction related to an index treated lesion
  • Target lesion myocardial infarction [ Time Frame: 12 months ]
    Myocardial infarction related to an index treated lesion
  • Target lesion myocardial infarction [ Time Frame: 24 months ]
    Myocardial infarction related to an index treated lesion
  • Target lesion myocardial infarction [ Time Frame: 36 months ]
    Myocardial infarction related to an index treated lesion
  • Target lesion myocardial infarction [ Time Frame: 48 months ]
    Myocardial infarction related to an index treated lesion
  • Target lesion myocardial infarction [ Time Frame: 60 months ]
    Myocardial infarction related to an index treated lesion
  • Target lesion revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI of index lesion
  • Target lesion revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI of index lesion
  • Target lesion revascularisation [ Time Frame: 24 months ]
    Coronary artery bypass grafting or PCI of index lesion
  • Target lesion revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI of index lesion
  • Target lesion revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI of index lesion
  • Target lesion revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI of index lesion
  • Target bifurcation myocardial infarction [ Time Frame: 1 month ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation myocardial infarction [ Time Frame: 12 months ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation myocardial infarction [ Time Frame: 24 months ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation myocardial infarction [ Time Frame: 36 months ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation myocardial infarction [ Time Frame: 48 months ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation myocardial infarction [ Time Frame: 60 months ]
    Myocardial infarction related to the index bifurcation
  • Target bifurcation revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI of index bifurcation
  • Target bifurcation revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI of index bifurcation
  • Target bifurcation revascularisation [ Time Frame: 24 months ]
    Coronary artery bypass grafting or PCI of index bifurcation
  • Target bifurcation revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI of index bifurcation
  • Target bifurcation revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI of index bifurcation
  • Target bifurcation revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI of index bifurcation
  • Target vessel revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI related to target vessel lesion
  • Target vessel revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI related to target vessel lesion
  • Target vessel revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI related to target vessel lesion
  • Target vessel revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI related to target vessel lesion
  • Target vessel revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI related to target vessel lesion
  • Any revascularisation [ Time Frame: 1 month ]
    Any repeat revascularization except staged procedures planned at the index procedure
  • Any revascularisation [ Time Frame: 12 months ]
    Any repeat revascularization except staged procedures planned at the index procedure
  • Any revascularisation [ Time Frame: 24 months ]
    Any repeat revascularization except staged procedures planned at the index procedure
  • Any revascularisation [ Time Frame: 36 months ]
    Any repeat revascularization except staged procedures planned at the index procedure
  • Any revascularisation [ Time Frame: 48 months ]
    Any repeat revascularization except staged procedures planned at the index procedure
  • Any revascularisation [ Time Frame: 60 months ]
    Any repeat revascularization except staged procedures planned at the index procedure
  • CCS angina class [ Time Frame: 1 month ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • CCS angina class [ Time Frame: 12 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • CCS angina class [ Time Frame: 24 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • CCS angina class [ Time Frame: 36 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • CCS angina class [ Time Frame: 48 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • CCS angina class [ Time Frame: 60 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris
  • NYHA class [ Time Frame: 1 month ]
    New York Heart Association (NYHA) Functional Classification
  • NYHA class [ Time Frame: 12 months ]
    New York Heart Association (NYHA) Functional Classification
  • NYHA class [ Time Frame: 24 months ]
    New York Heart Association (NYHA) Functional Classification
  • NYHA class [ Time Frame: 36 months ]
    New York Heart Association (NYHA) Functional Classification
  • NYHA class [ Time Frame: 48 months ]
    New York Heart Association (NYHA) Functional Classification
  • NYHA class [ Time Frame: 60 months ]
    New York Heart Association (NYHA) Functional Classification
  • Minimal lumen area in proximal main vessel segment [ Time Frame: 1 day ]
    Minimal lumen area by 3D quantitative coronary analysis (QCA) in the stented segment including edge just proximal to the target bifurcation
  • Minimal lumen area in distal main vessel segment [ Time Frame: 1 day ]
    Minimal lumen area by 3D quantitative coronary analysis (QCA) in the stented segment including edge just distal to the target bifurcation
  • Minimal lumen area in the side branch segment [ Time Frame: 1 day ]
    Minimal lumen area by 3D quantitative coronary analysis (QCA) in the proximal stented or balloon treated side branch segment including edge, of the target bifurcation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Official Title  ICMJE European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction - The OCTOBER Trial -
Brief Summary The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation
Detailed Description

Coronary bifurcation lesions with stenosis in a large side branch may require complex stent implantation techniques with an elevated risk of suboptimal treatment results. Intra vascular optical coherence tomography (OCT) enables improved procedural control of correctable factors and may lead to optimized implantation results.

It is unknown if routine, systematic use of OCT scans during complex bifurcation stenting improves clinical outcome but present available evidence indicates advantages of OCT guidance that could translate into improved clinical outcome.

Hypothesis: Systematic OCT guided revascularization of patients with bifurcation lesions requiring complex stent implantation provides superior two-year clinical outcome compared to standard revascularization by PCI.

Methods: Investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective, multicenter, superiority trial. Randomization is stratified for 1) Left main or non-Left main artery disease, and 2) up-front planned one-stent technique with kissing balloon inflation, or a two-stent technique.

Systematic OCT guidance is detailed for five complex stent implantation techniques. Standard treatment is angiographic based with optional use of intravascular ultrasound (IVUS).
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
  • Ischaemic Heart Disease
  • Ischemic Heart Disease
Intervention  ICMJE
  • Procedure: Angiographic guided PCI
    Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques
    Other Name: PCI, percutaneous transluminal coronary angioplasty (PTCA)
  • Procedure: OCT guided PCI
    OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans
    Other Name: OCT
Study Arms  ICMJE
  • Active Comparator: Angiographic guided PCI
    Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).
    Intervention: Procedure: Angiographic guided PCI
  • Experimental: OCT guided PCI
    OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
    Intervention: Procedure: OCT guided PCI
Publications * Holm NR, Andreasen LN, Walsh S, Kajander OA, Witt N, Eek C, Knaapen P, Koltowski L, Gutierrez-Chico JL, Burzotta F, Kockman J, Ormiston J, Santos-Pardo I, Laanmets P, Mylotte D, Madsen M, Hjort J, Kumsars I, Ramunddal T, Christiansen EH. Rational and design of the European randomized Optical Coherence Tomography Optimized Bifurcation Event Reduction Trial (OCTOBER). Am Heart J. 2018 Nov;205:97-109. doi: 10.1016/j.ahj.2018.08.003. Epub 2018 Aug 16.

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 11, 2023)		 1201
Original Estimated Enrollment  ICMJE
 (submitted: May 30, 2017)		 1200
Estimated Study Completion Date  ICMJE May 2029
Actual Primary Completion Date March 25, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Stable angina pectoris, unstable angina pectoris, clinically stable non-STEMI.
  • Age ≥18 yrs.
  • Abel to provide written Informed consent and willing to comply with the specified follow-up contacts.

Angiographic inclusion criteria:

  • Native coronary bifurcation de novo lesion
  • More than 50% diameter stenosis in the main vessel (MV)
  • More than 50% diameter stenosis in the side branch (SB) within 5 mm of the ostium.
  • Reference size at least 2.75 mm in the main vessel (MV) and ≥2.5 mm in the SB.

Functional inclusion criteria:

Functional significance of the main vessel lesion or documented ischemia of the main vessel territory or other objective documentation of lesion significance. Objective evidence of ischemia is required for all treated lesions except for lesions with more than 80% diameter stenosis that may be considered significant.

Procedural inclusion criteria:

Indication for two-stent technique or one-stent technique with kissing balloon inflation

Exclusion Criteria:

  • STEMI within 72 hours
  • Cardiogenic shock
  • Prior coronary artery bypass grafting (CABG) or planned CABG
  • Renal failure with glomerular filtration rate (GFR) <50 mL/min per 1.73 m2
  • Active bleeding or coagulopathy
  • Life expectancy < 2 years
  • Ejection fraction < 30%
  • New York Heart Association (NYHA) class > II
  • Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus).

Angiographic exclusion criteria:

  • Severe tortuosity around target bifurcation
  • Chronic total occlusions
  • Massive thrombus in Left main coronary artery
  • Medina 0.0.1 lesions
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 Belgium,   Denmark,   Estonia,   Finland,   Germany,   Ireland,   Italy,   Latvia,   Netherlands,   Norway,   Poland,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03171311
Other Study ID Numbers  ICMJE 1-10-72-161-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Is decided after primary endpoint assessment and requires regulatory approval
Current Responsible Party Evald Hoej Christiansen, Aarhus University Hospital Skejby
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aarhus University Hospital Skejby
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Abbott
Investigators  ICMJE
Study Chair: Evald H Christiansen, MD, PhD Aarhus University Hospital, Denmark
PRS Account Aarhus University Hospital Skejby
Verification Date June 2023

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