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Ischaemic Heart DiseaseOCTOBERNCT03171311

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

A study testing Angiographic guided PCI and OCT guided PCI in people with Ischaemic Heart Disease and Ischemic Heart Disease, run by Aarhus University Hospital Skejby at 38 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Angiographic guided PCI and OCT guided PCI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,201 participants
Where
38 sitesin 13 countries
Study dates
5 Jul 2017to May 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

38 sites in 13 countries.

38 sites in 13 countries

United Kingdom7 sites

  • Belfast Health and Social Care Trust

    Belfast, BT9 7AB

  • Royal Bournemouth Hospital

    Bournemouth, BH77DW

  • Sussex Cardiac Centre

    Brighton, BN2 5BE

  • Golden Jubilee Hospital

    Glasgow, G81 4DY

  • St George's Hospital

    London, SW17 0QT

  • University Hospital South Manchester, Wythenshawe Hospital

    Manchester, M239LT

  • Morriston Hospital

    Swansea, SA6 6NL

Other trials in United Kingdom

Denmark6 sites

  • Aalborg University Hospital

    Aalborg, 9100

  • Aarhus University Hospital Skejby

    Aarhus N, 8200

  • Gentofte Hospital

    Gentofte Municipality, 2820

  • Rigshospitalet

    København Ø, 2100

  • Odense University Hospital

    Odense, 5000

  • Zealand University Hospital, Roskilde Sygehus

    Roskilde, 4000

Other trials in Denmark

Norway5 sites

  • Hospital of Southern Norway, Arendal

    Arendal, 4604

  • Haukeland University Hospital, Bergen

    Bergen

  • Oslo University Hospital, Rikshospitalet

    Oslo, 0424

  • Oslo University Hospital - Ullevål

    Oslo, 0450

  • Trondheim University Hospital

    Trondheim

Other trials in Norway

Germany4 sites

  • Vivantes Klinikum im Friedrichshain

    Berlin, State of Berlin, 10249

  • Universitäres Herzzentrum Hamburg

    Hamburg, 20246

  • Cardiologicum Hamburg

    Hamburg, 22041

  • Universitätsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

Other trials in Germany

Sweden4 sites

  • Sahlgrenska University Hospital

    Gothenburg, 413 45

  • Karolinska University Hospital Huddinge

    Huddinge, Stockholm County, 14157

  • Örebro University Hospital

    Örebro, 70185

  • Södersjukhuset

    Stockholm, 118 83

Other trials in Sweden

Netherlands3 sites

  • Northwest Hospital Alkmaar

    Alkmaar, 1815

  • VU University Medical Center (VUMC)

    Amsterdam, 1081 HV

  • St Antonius Ziekenhuis

    Nieuwegein, 3435 CM

Other trials in Netherlands

Belgium2 sites

  • Ziekenhuis Oost-Limburg (ZOL) Genk

    Genk, 3600

  • Leuven University Hospital

    Leuven, 3000

Other trials in Belgium

Italy2 sites

  • Azienda Ospedaliero-Universitaria di Ferrara

    Ferrara, Cona, 44124

  • Gemelli General Hospital, Catholic University of the Sacred Heart

    Rome, 00168

Other trials in Italy

Estonia1 site

  • Estonia Medical Centre

    Tallinn, 13419

Other trials in Estonia

Finland1 site

  • Tampere University Hospital

    Tampere, 33520

Other trials in Finland

Ireland1 site

  • University Hospital Galway

    Galway, H91YR71

Other trials in Ireland

Latvia1 site

  • Latvia Centre of Cardiology

    Riga, LV-1002

Other trials in Latvia

Poland1 site

  • Medical University of Warsaw

    Warsaw, 02-097

Other trials in Poland

About this study

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

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

Read the 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).

Being tested
Angiographic guided PCI, OCT guided PCI
Medical subject headings
Coronary Artery Disease, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Angiographic guided PCIProcedure or surgery

    Also called PCI, percutaneous transluminal coronary angioplasty (PTCA)

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

  • OCT guided PCIProcedure or surgery

    Also called OCT

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

Study groups in NCT03171311
Study groupRoleWhat they receive
Angiographic guided PCIActive comparatorAngiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).
Receives: Procedure: Angiographic guided PCI
OCT guided PCIExperimentalOCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
Receives: Procedure: OCT guided PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Combined endpoint of major adverse cardiac events (MACE)

    Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization

    Measured: 24 months

Secondary outcomes (114)

  1. Study bifurcation oriented composite endpoint

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

    Measured: 1 month

  2. Study bifurcation oriented composite endpoint

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

    Measured: 12 months

  3. Study bifurcation oriented composite endpoint

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

    Measured: 24 months

  4. Study bifurcation oriented composite endpoint

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

    Measured: 36 months

  5. Study bifurcation oriented composite endpoint

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

    Measured: 48 months

  6. Study bifurcation oriented composite endpoint

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

    Measured: 60 months

  7. Patient oriented composite endpoint

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

    Measured: 1 month

  8. Patient oriented composite endpoint

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

    Measured: 12 months

  9. Patient oriented composite endpoint

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

    Measured: 24 months

  10. Patient oriented composite endpoint

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

    Measured: 36 months

  11. Patient oriented composite endpoint

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

    Measured: 48 months

  12. Patient oriented composite endpoint

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

    Measured: 60 months

  13. All-cause mortality

    Death of any cause including cardiac deaths and non-natural causes of death

    Measured: 1 month

  14. All-cause mortality

    Death of any cause including cardiac deaths and non-natural causes of death

    Measured: 12 months

  15. All-cause mortality

    Death of any cause including cardiac deaths and non-natural causes of death

    Measured: 24 months

  16. All-cause mortality

    Death of any cause including cardiac deaths and non-natural causes of death

    Measured: 36 months

  17. All-cause mortality

    Death of any cause including cardiac deaths and non-natural causes of death

    Measured: 48 months

  18. All-cause mortality

    Death of any cause including cardiac deaths and non-natural causes of death

    Measured: 60 months

  19. All-cause mortality

    Death of any cause including cardiac deaths and non-natural causes of death

    Measured: 120 months

  20. Cardiac death

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

    Measured: 1 month

  21. Cardiac death

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

    Measured: 12 months

  22. Cardiac death

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

    Measured: 24 months

  23. Cardiac death

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

    Measured: 36 months

  24. Cardiac death

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

    Measured: 48 months

  25. Cardiac death

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

    Measured: 60 months

  26. Myocardial infarction

    Procedure and non-procedure related myocardial infarction

    Measured: 1 month

  27. Myocardial infarction

    Procedure and non-procedure related myocardial infarction

    Measured: 12 months

  28. Myocardial infarction

    Procedure and non-procedure related myocardial infarction

    Measured: 24 months

  29. Myocardial infarction

    Procedure and non-procedure related myocardial infarction

    Measured: 36 months

  30. Myocardial infarction

    Procedure and non-procedure related myocardial infarction

    Measured: 48 months

  31. Myocardial infarction

    Procedure and non-procedure related myocardial infarction

    Measured: 60 months

  32. Stent Thrombosis

    Definite, possible or probable

    Measured: 1 month

  33. Stent Thrombosis

    Definite, possible or probable

    Measured: 12 months

  34. Stent Thrombosis

    Definite, possible or probable

    Measured: 24 months

  35. Stent Thrombosis

    Definite, possible or probable

    Measured: 36 months

  36. Stent Thrombosis

    Definite, possible or probable

    Measured: 48 months

  37. Stent Thrombosis

    Definite, possible or probable

    Measured: 60 months

  38. Target lesion myocardial infarction

    Myocardial infarction related to an index treated lesion

    Measured: 1 month

  39. Target lesion myocardial infarction

    Myocardial infarction related to an index treated lesion

    Measured: 12 months

  40. Target lesion myocardial infarction

    Myocardial infarction related to an index treated lesion

    Measured: 24 months

  41. Target lesion myocardial infarction

    Myocardial infarction related to an index treated lesion

    Measured: 36 months

  42. Target lesion myocardial infarction

    Myocardial infarction related to an index treated lesion

    Measured: 48 months

  43. Target lesion myocardial infarction

    Myocardial infarction related to an index treated lesion

    Measured: 60 months

  44. Target lesion revascularisation

    Coronary artery bypass grafting or PCI of target lesion

    Measured: 1 month

  45. Target lesion revascularisation

    Coronary artery bypass grafting or PCI of target lesion

    Measured: 12 months

  46. Target lesion revascularisation

    Coronary artery bypass grafting or PCI of target lesion

    Measured: 24 months

  47. Target lesion revascularisation

    Coronary artery bypass grafting or PCI of target lesion

    Measured: 36 months

  48. Target lesion revascularisation

    Coronary artery bypass grafting or PCI of target lesion

    Measured: 48 months

  49. Target lesion revascularisation

    Coronary artery bypass grafting or PCI of target lesion

    Measured: 60 months

  50. Target bifurcation myocardial infarction

    Myocardial infarction related to the index bifurcation

    Measured: 1 month

  51. Target bifurcation myocardial infarction

    Myocardial infarction related to the index bifurcation

    Measured: 12 months

  52. Target bifurcation myocardial infarction

    Myocardial infarction related to the index bifurcation

    Measured: 24 months

  53. Target bifurcation myocardial infarction

    Myocardial infarction related to the index bifurcation

    Measured: 36 months

  54. Target bifurcation myocardial infarction

    Myocardial infarction related to the index bifurcation

    Measured: 48 months

  55. Target bifurcation myocardial infarction

    Myocardial infarction related to the index bifurcation

    Measured: 60 months

  56. Target bifurcation revascularisation

    Coronary artery bypass grafting or PCI of target bifurcation

    Measured: 1 month

  57. Target bifurcation revascularisation

    Coronary artery bypass grafting or PCI of target bifurcation

    Measured: 12 months

  58. Target bifurcation revascularisation

    Coronary artery bypass grafting or PCI of target bifurcation

    Measured: 24 months

  59. Target bifurcation revascularisation

    Coronary artery bypass grafting or PCI of target bifurcation

    Measured: 36 months

  60. Target bifurcation revascularisation

    Coronary artery bypass grafting or PCI of target bifurcation

    Measured: 48 months

  61. Target bifurcation revascularisation

    Coronary artery bypass grafting or PCI of target bifurcation

    Measured: 60 months

  62. Target vessel revascularisation

    Coronary artery bypass grafting or PCI of target vessel

    Measured: 1 month

  63. Target vessel revascularisation

    Coronary artery bypass grafting or PCI of target vessel

    Measured: 12 months

  64. Target vessel revascularisation

    Coronary artery bypass grafting or PCI of target vessel

    Measured: 24 months

  65. Target vessel revascularisation

    Coronary artery bypass grafting or PCI of target vessel

    Measured: 36 months

  66. Target vessel revascularisation

    Coronary artery bypass grafting or PCI of target vessel

    Measured: 48 months

  67. Target vessel revascularisation

    Coronary artery bypass grafting or PCI of target vessel

    Measured: 60 months

  68. Any revascularisation

    Any repeat revascularization except staged revascularization planned during the index procedure

    Measured: 1 month

  69. Any revascularisation

    Any repeat revascularization except staged revascularization planned during the index procedure

    Measured: 12 months

  70. Any revascularisation

    Any repeat revascularization except staged revascularization planned during the index procedure

    Measured: 24 months

  71. Any revascularisation

    Any repeat revascularization except staged revascularization planned during the index procedure

    Measured: 36 months

  72. Any revascularisation

    Any repeat revascularization except staged revascularization planned during the index procedure

    Measured: 48 months

  73. Any revascularisation

    Any repeat revascularization except staged revascularization planned during the index procedure

    Measured: 60 months

  74. CCS angina class

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

    Measured: 1 month

  75. CCS angina class

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

    Measured: 12 months

  76. CCS angina class

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

    Measured: 24 months

  77. CCS angina class

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

    Measured: 36 months

  78. CCS angina class

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

    Measured: 48 months

  79. CCS angina class

    Canadian Cardiovascular Society (CCS) grading of angina pectoris

    Measured: 60 months

  80. Contrast volume

    Contrast volume

    Measured: Baseline, after final baseline procedure

  81. Procedure time

    Procedure time

    Measured: Baseline, after final baseline procedure

  82. Fluoroscopy time

    Fluoroscopy time

    Measured: Baseline, after final baseline procedure

  83. Number of stents implanted in target lesion

    Number of stents implanted in target lesion

    Measured: Baseline, after final baseline procedure

  84. Number of stents implanted in non-target lesion

    Number of stents implanted in non-target lesion

    Measured: Baseline, after final baseline procedure

  85. Total stent length in target lesion

    Total stent length in target lesion

    Measured: Baseline, just after final baseline procedure

  86. Total stent length in total

    Total stent length in total

    Measured: Baseline, just after final baseline procedure

  87. Procedural success

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, after final baseline procedure

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

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

    Measured: Baseline, after final baseline procedure

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

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

    Measured: Baseline, after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, after final baseline procedure

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

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

    Measured: Baseline, after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, after final baseline procedure

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

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

    Measured: Baseline, after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

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

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

    Measured: Baseline, just after final baseline procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2017
  2. Study start5 Jul 2017
  3. Primary completion25 Mar 2022
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03171311
Sponsor's protocol ID
1-10-72-161-16
Acronym
OCTOBER
Status last verified
Nov 2026
First submitted
28 May 2017
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Is decided after primary endpoint assessment and requires regulatory approval

Publications

  • Holm NR, Andreasen LD, Neghabat O, Laanmets P, Kumsars I, Bennett J, Olsen NT, Odenstedt J, Hoffmann P, Dens J, Chowdhary S, O'Kane P, Bulow Rasmussen SH, Heigert M, Havndrup O, Van Kuijk JP, Biscaglia S, Mogensen LJH, Henareh L, Burzotta F, H Eek C, Mylotte D, Llinas MS, Koltowski L, Knaapen P, Calic S, Witt N, Santos-Pardo I, Watkins S, Lonborg J, Kristensen AT, Jensen LO, Calais F, Cockburn J, McNeice A, Kajander OA, Heestermans T, Kische S, Eftekhari A, Spratt JC, Christiansen EH; OCTOBER Trial Group. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med. 2023 Oct 19;389(16):1477-1487. doi: 10.1056/NEJMoa2307770. Epub 2023 Aug 27.

    PubMed 37634149

  • 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.

    PubMed 30205242

Questions about this trial

What is this clinical trial studying?

A study testing Angiographic guided PCI and OCT guided PCI in people with Ischaemic Heart Disease and Ischemic Heart Disease, run by Aarhus University Hospital Skejby at 38 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United Kingdom, Denmark, Norway, Germany, Sweden and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Combined endpoint of major adverse cardiac events (MACE) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03171311, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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