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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03171311
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital Skejby

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

Condition or disease Intervention/treatment Phase
Ischaemic Heart Disease Ischemic Heart Disease Procedure: Angiographic guided PCI Procedure: OCT guided PCI Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction - The OCTOBER Trial -
Actual Study Start Date : July 5, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2029

Arm Intervention/treatment
Active Comparator: Angiographic guided PCI
Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).
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)

Experimental: OCT guided PCI
OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
Procedure: OCT guided PCI
OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans
Other Name: OCT




Primary Outcome Measures :
  1. Combined endpoint of major adverse cardiovascular events (MACE) [ Time Frame: 24 months ]
    cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization


Secondary Outcome Measures :
  1. Study bifurcation oriented composite endpoint of MACE [ Time Frame: 1 month ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  2. Study bifurcation oriented composite endpoint of MACE [ Time Frame: 12 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  3. Study bifurcation oriented composite endpoint of MACE [ Time Frame: 24 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  4. Study bifurcation oriented composite endpoint of MACE [ Time Frame: 36 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  5. Study bifurcation oriented composite endpoint of MACE [ Time Frame: 48 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  6. Study bifurcation oriented composite endpoint of MACE [ Time Frame: 60 months ]
    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  7. Patient oriented composite endpoint endpoint of MACE [ Time Frame: 1 month ]
    All cause mortality, myocardial infarction, any revascularisation, stroke

  8. Patient oriented composite endpoint endpoint of MACE [ Time Frame: 12 months ]
    All cause mortality, myocardial infarction, any revascularisation, stroke

  9. Patient oriented composite endpoint endpoint of MACE [ Time Frame: 24 months ]
    All cause mortality, myocardial infarction, any revascularisation, stroke

  10. Patient oriented composite endpoint endpoint of MACE [ Time Frame: 36 months ]
    All cause mortality, myocardial infarction, any revascularisation, stroke

  11. Patient oriented composite endpoint endpoint of MACE [ Time Frame: 48 months ]
    All cause mortality, myocardial infarction, any revascularisation, stroke

  12. Patient oriented composite endpoint endpoint of MACE [ Time Frame: 60 months ]
    All cause mortality, myocardial infarction, any revascularisation, stroke

  13. All-cause mortality [ Time Frame: 1 month ]
    Death of any cause including cardiac deaths and non-natural causes of death

  14. All-cause mortality [ Time Frame: 12 months ]
    Death of any cause including cardiac deaths and non-natural causes of death

  15. All-cause mortality [ Time Frame: 24 months ]
    Death of any cause including cardiac deaths and non-natural causes of death

  16. All-cause mortality [ Time Frame: 36 months ]
    Death of any cause including cardiac deaths and non-natural causes of death

  17. All-cause mortality [ Time Frame: 48 months ]
    Death of any cause including cardiac deaths and non-natural causes of death

  18. All-cause mortality [ Time Frame: 60 months ]
    Death of any cause including cardiac deaths and non-natural causes of death

  19. All-cause mortality [ Time Frame: 120 months ]
    Death of any cause including cardiac deaths and non-natural causes of death

  20. Cardiac death [ Time Frame: 1 month ]
    Death due to cardiovascular disease

  21. Cardiac death [ Time Frame: 12 months ]
    Death due to cardiovascular disease

  22. Cardiac death [ Time Frame: 24 months ]
    Death due to cardiovascular disease

  23. Cardiac death [ Time Frame: 36 months ]
    Death due to cardiovascular disease

  24. Cardiac death [ Time Frame: 48 months ]
    Death due to cardiovascular disease

  25. Cardiac death [ Time Frame: 60 months ]
    Death due to cardiovascular disease

  26. Myocardial infarction [ Time Frame: 1 month ]
    Procedure and non-procedure related myocardial infarction

  27. Myocardial infarction [ Time Frame: 12 months ]
    Procedure and non-procedure related myocardial infarction

  28. Myocardial infarction [ Time Frame: 24 months ]
    Procedure and non-procedure related myocardial infarction

  29. Myocardial infarction [ Time Frame: 36 months ]
    Procedure and non-procedure related myocardial infarction

  30. Myocardial infarction [ Time Frame: 48 months ]
    Procedure and non-procedure related myocardial infarction

  31. Myocardial infarction [ Time Frame: 60 months ]
    Procedure and non-procedure related myocardial infarction

  32. Stent Thrombosis [ Time Frame: 1 month ]
    Definite, possible or probable

  33. Stent Thrombosis [ Time Frame: 12 months ]
    Definite, possible or probable

  34. Stent Thrombosis [ Time Frame: 24 months ]
    Definite, possible or probable

  35. Stent Thrombosis [ Time Frame: 36 months ]
    Definite, possible or probable

  36. Stent Thrombosis [ Time Frame: 48 months ]
    Definite, possible or probable

  37. Stent Thrombosis [ Time Frame: 60 months ]
    Definite, possible or probable

  38. Target lesion myocardial infarction [ Time Frame: 1 month ]
    Myocardial infarction related to an index treated lesion

  39. Target lesion myocardial infarction [ Time Frame: 12 months ]
    Myocardial infarction related to an index treated lesion

  40. Target lesion myocardial infarction [ Time Frame: 24 months ]
    Myocardial infarction related to an index treated lesion

  41. Target lesion myocardial infarction [ Time Frame: 36 months ]
    Myocardial infarction related to an index treated lesion

  42. Target lesion myocardial infarction [ Time Frame: 48 months ]
    Myocardial infarction related to an index treated lesion

  43. Target lesion myocardial infarction [ Time Frame: 60 months ]
    Myocardial infarction related to an index treated lesion

  44. Target lesion revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI of index lesion

  45. Target lesion revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI of index lesion

  46. Target lesion revascularisation [ Time Frame: 24 months ]
    Coronary artery bypass grafting or PCI of index lesion

  47. Target lesion revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI of index lesion

  48. Target lesion revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI of index lesion

  49. Target lesion revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI of index lesion

  50. Target bifurcation myocardial infarction [ Time Frame: 1 month ]
    Myocardial infarction related to the index bifurcation

  51. Target bifurcation myocardial infarction [ Time Frame: 12 months ]
    Myocardial infarction related to the index bifurcation

  52. Target bifurcation myocardial infarction [ Time Frame: 24 months ]
    Myocardial infarction related to the index bifurcation

  53. Target bifurcation myocardial infarction [ Time Frame: 36 months ]
    Myocardial infarction related to the index bifurcation

  54. Target bifurcation myocardial infarction [ Time Frame: 48 months ]
    Myocardial infarction related to the index bifurcation

  55. Target bifurcation myocardial infarction [ Time Frame: 60 months ]
    Myocardial infarction related to the index bifurcation

  56. Target bifurcation revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI of index bifurcation

  57. Target bifurcation revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI of index bifurcation

  58. Target bifurcation revascularisation [ Time Frame: 24 months ]
    Coronary artery bypass grafting or PCI of index bifurcation

  59. Target bifurcation revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI of index bifurcation

  60. Target bifurcation revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI of index bifurcation

  61. Target bifurcation revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI of index bifurcation

  62. Target vessel revascularisation [ Time Frame: 1 month ]
    Coronary artery bypass grafting or PCI related to target vessel lesion

  63. Target vessel revascularisation [ Time Frame: 12 months ]
    Coronary artery bypass grafting or PCI related to target vessel lesion

  64. Target vessel revascularisation [ Time Frame: 36 months ]
    Coronary artery bypass grafting or PCI related to target vessel lesion

  65. Target vessel revascularisation [ Time Frame: 48 months ]
    Coronary artery bypass grafting or PCI related to target vessel lesion

  66. Target vessel revascularisation [ Time Frame: 60 months ]
    Coronary artery bypass grafting or PCI related to target vessel lesion

  67. Any revascularisation [ Time Frame: 1 month ]
    Any repeat revascularization except staged procedures planned at the index procedure

  68. Any revascularisation [ Time Frame: 12 months ]
    Any repeat revascularization except staged procedures planned at the index procedure

  69. Any revascularisation [ Time Frame: 24 months ]
    Any repeat revascularization except staged procedures planned at the index procedure

  70. Any revascularisation [ Time Frame: 36 months ]
    Any repeat revascularization except staged procedures planned at the index procedure

  71. Any revascularisation [ Time Frame: 48 months ]
    Any repeat revascularization except staged procedures planned at the index procedure

  72. Any revascularisation [ Time Frame: 60 months ]
    Any repeat revascularization except staged procedures planned at the index procedure

  73. CCS angina class [ Time Frame: 1 month ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  74. CCS angina class [ Time Frame: 12 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  75. CCS angina class [ Time Frame: 24 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  76. CCS angina class [ Time Frame: 36 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  77. CCS angina class [ Time Frame: 48 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  78. CCS angina class [ Time Frame: 60 months ]
    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  79. NYHA class [ Time Frame: 1 month ]
    New York Heart Association (NYHA) Functional Classification

  80. NYHA class [ Time Frame: 12 months ]
    New York Heart Association (NYHA) Functional Classification

  81. NYHA class [ Time Frame: 24 months ]
    New York Heart Association (NYHA) Functional Classification

  82. NYHA class [ Time Frame: 36 months ]
    New York Heart Association (NYHA) Functional Classification

  83. NYHA class [ Time Frame: 48 months ]
    New York Heart Association (NYHA) Functional Classification

  84. NYHA class [ Time Frame: 60 months ]
    New York Heart Association (NYHA) Functional Classification

  85. 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

  86. 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

  87. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03171311


Contacts
Layout table for location contacts
Contact: Evald H Christiansen, MD, PhD +4578450000 ext 52028 evald.christiansen@dadlnet.dk
Contact: Niels R Holm, MD +4578450000 ext 52054 niels.holm@clin.au.dk

Locations
Show Show 56 study locations
Sponsors and Collaborators
Aarhus University Hospital Skejby
Abbott
Investigators
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Study Chair: Evald H Christiansen, MD, PhD Aarhus University Hospital, Denmark
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Evald Hoej Christiansen, MD, phd, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT03171311    
Other Study ID Numbers: 1-10-72-161-16
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Is decided after primary endpoint assessment and requires regulatory approval

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases