Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03171311

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

The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Ischaemic Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Ischemic Heart Disease Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg (ZOL) Genk, Genk, Belgium

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Angiographic Guided PCI

Procedure

Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques

Other names: PCI, percutaneous transluminal coronary angioplasty (PTCA)

OCT Guided PCI

Procedure

OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans

Other names: OCT

Primary outcomes

  1. 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

Secondary outcomes

  1. Study bifurcation oriented composite endpoint

    Time frame: 1 month

    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  2. Study bifurcation oriented composite endpoint

    Time frame: 12 months

    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  3. Study bifurcation oriented composite endpoint

    Time frame: 24 months

    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  4. Study bifurcation oriented composite endpoint

    Time frame: 36 months

    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  5. Study bifurcation oriented composite endpoint

    Time frame: 48 months

    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  6. Study bifurcation oriented composite endpoint

    Time frame: 60 months

    Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

  7. Patient oriented composite endpoint

    Time frame: 1 month

    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke

  8. Patient oriented composite endpoint

    Time frame: 12 months

    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke

  9. Patient oriented composite endpoint

    Time frame: 24 months

    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke

  10. Patient oriented composite endpoint

    Time frame: 36 months

    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke

  11. Patient oriented composite endpoint

    Time frame: 48 months

    Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke

  12. Patient oriented composite endpoint

    Time frame: 60 months

    Composite of 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 cardiac causes or if death is not clearly attributable to other non-cardiac causes

  21. Cardiac death

    Time frame: 12 months

    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes

  22. Cardiac death

    Time frame: 24 months

    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes

  23. Cardiac death

    Time frame: 36 months

    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes

  24. Cardiac death

    Time frame: 48 months

    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes

  25. Cardiac death

    Time frame: 60 months

    Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes

  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 target lesion

  45. Target lesion revascularisation

    Time frame: 12 months

    Coronary artery bypass grafting or PCI of target lesion

  46. Target lesion revascularisation

    Time frame: 24 months

    Coronary artery bypass grafting or PCI of target lesion

  47. Target lesion revascularisation

    Time frame: 36 months

    Coronary artery bypass grafting or PCI of target lesion

  48. Target lesion revascularisation

    Time frame: 48 months

    Coronary artery bypass grafting or PCI of target lesion

  49. Target lesion revascularisation

    Time frame: 60 months

    Coronary artery bypass grafting or PCI of target 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 target bifurcation

  57. Target bifurcation revascularisation

    Time frame: 12 months

    Coronary artery bypass grafting or PCI of target bifurcation

  58. Target bifurcation revascularisation

    Time frame: 24 months

    Coronary artery bypass grafting or PCI of target bifurcation

  59. Target bifurcation revascularisation

    Time frame: 36 months

    Coronary artery bypass grafting or PCI of target bifurcation

  60. Target bifurcation revascularisation

    Time frame: 48 months

    Coronary artery bypass grafting or PCI of target bifurcation

  61. Target bifurcation revascularisation

    Time frame: 60 months

    Coronary artery bypass grafting or PCI of target bifurcation

  62. Target vessel revascularisation

    Time frame: 1 month

    Coronary artery bypass grafting or PCI of target vessel

  63. Target vessel revascularisation

    Time frame: 12 months

    Coronary artery bypass grafting or PCI of target vessel

  64. Target vessel revascularisation

    Time frame: 24 months

    Coronary artery bypass grafting or PCI of target vessel

  65. Target vessel revascularisation

    Time frame: 36 months

    Coronary artery bypass grafting or PCI of target vessel

  66. Target vessel revascularisation

    Time frame: 48 months

    Coronary artery bypass grafting or PCI of target vessel

  67. Target vessel revascularisation

    Time frame: 60 months

    Coronary artery bypass grafting or PCI of target vessel

  68. Any revascularisation

    Time frame: 1 month

    Any repeat revascularization except staged revascularization planned during the index procedure

  69. Any revascularisation

    Time frame: 12 months

    Any repeat revascularization except staged revascularization planned during the index procedure

  70. Any revascularisation

    Time frame: 24 months

    Any repeat revascularization except staged revascularization planned during the index procedure

  71. Any revascularisation

    Time frame: 36 months

    Any repeat revascularization except staged revascularization planned during the index procedure

  72. Any revascularisation

    Time frame: 48 months

    Any repeat revascularization except staged revascularization planned during the index procedure

  73. Any revascularisation

    Time frame: 60 months

    Any repeat revascularization except staged revascularization planned during the index procedure

  74. CCS angina class

    Time frame: 1 month

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  75. CCS angina class

    Time frame: 12 months

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  76. CCS angina class

    Time frame: 24 months

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  77. CCS angina class

    Time frame: 36 months

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  78. CCS angina class

    Time frame: 48 months

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  79. CCS angina class

    Time frame: 60 months

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

  80. Contrast volume

    Time frame: Baseline, after final baseline procedure

    Contrast volume

  81. Procedure time

    Time frame: Baseline, after final baseline procedure

    Procedure time

  82. Fluoroscopy time

    Time frame: Baseline, after final baseline procedure

    Fluoroscopy time

  83. Number of stents implanted in target lesion

    Time frame: Baseline, after final baseline procedure

    Number of stents implanted in target lesion

  84. Number of stents implanted in non-target lesion

    Time frame: Baseline, after final baseline procedure

    Number of stents implanted in non-target lesion

  85. Total stent length in target lesion

    Time frame: Baseline, just after final baseline procedure

    Total stent length in target lesion

  86. Total stent length in total

    Time frame: Baseline, just after final baseline procedure

    Total stent length in total

  87. Procedural success

    Time frame: Baseline, just after final baseline procedure

    TIMI III flow and less than 30% diameter stenosis in target segments

  88. OCT-guiding group: Successful final OCT acquisition in MV

    Time frame: Baseline, just after final baseline procedure

    For OCT-guided enrollments. Successful final OCT acquisition in main vessel. Success defined as analyzable stented segment.

  89. OCT-guiding group: Successful final OCT acquisition in SB

    Time frame: Baseline, just after final baseline procedure

    For OCT-guided enrollments. Successful final OCT acquisition in side branch. Success defined as analyzable stented segment.

  90. OCT-guiding group: Successful treatment specific OCT acquisitions

    Time frame: Baseline, after final baseline procedure

    OCT performed succesfully in protocol-defined vessels at all protocol-defined time-points during baseline procedure

  91. Post-PCI minimal lumen diameter in the stented proximal main vessel segment

    Time frame: Baseline, after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented proximal main vessel segment

  92. Post-PCI minimal lumen diameter in the stented distal main vessel segment

    Time frame: Baseline, after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel segment

  93. Post-PCI minimal lumen diameter in the treated side branch vessel segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment

  94. Post-PCI minimal lumen diameter in the proximal main vessel edge segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)

  95. Post-PCI minimal lumen diameter in the distal main vessel edge segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)

  96. Post-PCI minimal lumen diameter in the side branch vessel edge segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)

  97. Post-PCI minimal lumen diameter in the stented bifurcation core segment

    Time frame: Baseline, after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented bifurcation core segment

  98. Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment

  99. Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated side branch vessel ostium segment

  100. Post-PCI diameter stenosis in the stented proximal main vessel segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented proximal main vessel segment

  101. Post-PCI diameter stenosis in the stented distal main vessel segment

    Time frame: Baseline, after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel segment

  102. Post-PCI diameter stenosis in the treated side branch vessel segment

    Time frame: Baseline, after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment

  103. Post-PCI diameter stenosis in the proximal main vessel edge segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)

  104. Post-PCI diameter stenosis in the distal main vessel edge segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)

  105. Post-PCI diameter stenosis in the side branch vessel edge segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)

  106. Post-PCI diameter stenosis in the stented bifurcation core segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented bifurcation core segment

  107. Post-PCI diameter stenosis in the stented distal main vessel ostium segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment

  108. Post-PCI diameter stenosis in the treated side branch ostium segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated side branch ostium segment

  109. Post-PCI minimal lumen diameter in non-bifurcation target stented segment

    Time frame: Baseline, after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target stented segment

  110. Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment

    Time frame: Baseline, after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment (within 5mm fra stent)

  111. Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment (within 5mm fra stent)

  112. Post-PCI diameter stenosis in non-bifurcation target stented segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target stented segment

  113. Post-PCI diameter stenosis in non-bifurcation target proximal edge segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment

  114. Post-PCI diameter stenosis in non-bifurcation target distal edge segment

    Time frame: Baseline, just after final baseline procedure

    Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Acronym: OCTOBER

Important dates

Study start
2017
Primary completion
2022
Study completion
2029
First posted
May 31, 2017
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.