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

Primary Purpose

Ischaemic Heart Disease, Ischemic Heart Disease

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Angiographic guided PCI
OCT guided PCI
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischaemic Heart Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuis Oost-Limburg (ZOL) Genk
  • Leuven University Hospital
  • Aalborg University Hospital
  • Aarhus University Hospital Skejby
  • Gentofte Hospital
  • Rigshospitalet
  • Odense University Hospital
  • Zealand University Hospital, Roskilde Sygehus
  • Estonia Medical Centre
  • Tampere University Hospital
  • Vivantes Klinikum im Friedrichshain
  • Universitäres Herzzentrum Hamburg
  • Cardiologicum Hamburg
  • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • University Hospital Galway
  • Azienda Ospedaliero-Universitaria di Ferrara
  • Gemelli General Hospital, Catholic University of the Sacred Heart
  • Latvia Centre of Cardiology
  • Northwest Hospital Alkmaar
  • VU University Medical Center (VUMC)
  • St Antonius Ziekenhuis
  • Hospital of Southern Norway, Arendal
  • Haukeland University Hospital, Bergen
  • Oslo University Hospital, Rikshospitalet
  • Oslo University Hospital - Ullevål
  • Trondheim University Hospital
  • Medical University of Warsaw
  • Karolinska University Hospital Huddinge
  • Sahlgrenska University Hospital
  • Örebro University Hospital
  • Södersjukhuset
  • Belfast Health and Social Care Trust
  • Royal Bournemouth Hospital
  • Sussex Cardiac Centre
  • Golden Jubilee Hospital
  • St George's Hospital
  • University Hospital South Manchester, Wythenshawe Hospital
  • Morriston Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Angiographic guided PCI

OCT guided PCI

Arm Description

Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).

OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)

Outcomes

Primary Outcome Measures

Combined endpoint of major adverse cardiac events (MACE)
Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization

Secondary Outcome Measures

Study bifurcation oriented composite endpoint
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Study bifurcation oriented composite endpoint
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Study bifurcation oriented composite endpoint
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Study bifurcation oriented composite endpoint
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Study bifurcation oriented composite endpoint
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Study bifurcation oriented composite endpoint
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Patient oriented composite endpoint
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Patient oriented composite endpoint
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Patient oriented composite endpoint
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Patient oriented composite endpoint
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Patient oriented composite endpoint
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Patient oriented composite endpoint
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
All-cause mortality
Death of any cause including cardiac deaths and non-natural causes of death
All-cause mortality
Death of any cause including cardiac deaths and non-natural causes of death
All-cause mortality
Death of any cause including cardiac deaths and non-natural causes of death
All-cause mortality
Death of any cause including cardiac deaths and non-natural causes of death
All-cause mortality
Death of any cause including cardiac deaths and non-natural causes of death
All-cause mortality
Death of any cause including cardiac deaths and non-natural causes of death
All-cause mortality
Death of any cause including cardiac deaths and non-natural causes of death
Cardiac death
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Cardiac death
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Cardiac death
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Cardiac death
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Cardiac death
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Cardiac death
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Myocardial infarction
Procedure and non-procedure related myocardial infarction
Myocardial infarction
Procedure and non-procedure related myocardial infarction
Myocardial infarction
Procedure and non-procedure related myocardial infarction
Myocardial infarction
Procedure and non-procedure related myocardial infarction
Myocardial infarction
Procedure and non-procedure related myocardial infarction
Myocardial infarction
Procedure and non-procedure related myocardial infarction
Stent Thrombosis
Definite, possible or probable
Stent Thrombosis
Definite, possible or probable
Stent Thrombosis
Definite, possible or probable
Stent Thrombosis
Definite, possible or probable
Stent Thrombosis
Definite, possible or probable
Stent Thrombosis
Definite, possible or probable
Target lesion myocardial infarction
Myocardial infarction related to an index treated lesion
Target lesion myocardial infarction
Myocardial infarction related to an index treated lesion
Target lesion myocardial infarction
Myocardial infarction related to an index treated lesion
Target lesion myocardial infarction
Myocardial infarction related to an index treated lesion
Target lesion myocardial infarction
Myocardial infarction related to an index treated lesion
Target lesion myocardial infarction
Myocardial infarction related to an index treated lesion
Target lesion revascularisation
Coronary artery bypass grafting or PCI of target lesion
Target lesion revascularisation
Coronary artery bypass grafting or PCI of target lesion
Target lesion revascularisation
Coronary artery bypass grafting or PCI of target lesion
Target lesion revascularisation
Coronary artery bypass grafting or PCI of target lesion
Target lesion revascularisation
Coronary artery bypass grafting or PCI of target lesion
Target lesion revascularisation
Coronary artery bypass grafting or PCI of target lesion
Target bifurcation myocardial infarction
Myocardial infarction related to the index bifurcation
Target bifurcation myocardial infarction
Myocardial infarction related to the index bifurcation
Target bifurcation myocardial infarction
Myocardial infarction related to the index bifurcation
Target bifurcation myocardial infarction
Myocardial infarction related to the index bifurcation
Target bifurcation myocardial infarction
Myocardial infarction related to the index bifurcation
Target bifurcation myocardial infarction
Myocardial infarction related to the index bifurcation
Target bifurcation revascularisation
Coronary artery bypass grafting or PCI of target bifurcation
Target bifurcation revascularisation
Coronary artery bypass grafting or PCI of target bifurcation
Target bifurcation revascularisation
Coronary artery bypass grafting or PCI of target bifurcation
Target bifurcation revascularisation
Coronary artery bypass grafting or PCI of target bifurcation
Target bifurcation revascularisation
Coronary artery bypass grafting or PCI of target bifurcation
Target bifurcation revascularisation
Coronary artery bypass grafting or PCI of target bifurcation
Target vessel revascularisation
Coronary artery bypass grafting or PCI of target vessel
Target vessel revascularisation
Coronary artery bypass grafting or PCI of target vessel
Target vessel revascularisation
Coronary artery bypass grafting or PCI of target vessel
Target vessel revascularisation
Coronary artery bypass grafting or PCI of target vessel
Target vessel revascularisation
Coronary artery bypass grafting or PCI of target vessel
Target vessel revascularisation
Coronary artery bypass grafting or PCI of target vessel
Any revascularisation
Any repeat revascularization except staged revascularization planned during the index procedure
Any revascularisation
Any repeat revascularization except staged revascularization planned during the index procedure
Any revascularisation
Any repeat revascularization except staged revascularization planned during the index procedure
Any revascularisation
Any repeat revascularization except staged revascularization planned during the index procedure
Any revascularisation
Any repeat revascularization except staged revascularization planned during the index procedure
Any revascularisation
Any repeat revascularization except staged revascularization planned during the index procedure
CCS angina class
Canadian Cardiovascular Society (CCS) grading of angina pectoris
CCS angina class
Canadian Cardiovascular Society (CCS) grading of angina pectoris
CCS angina class
Canadian Cardiovascular Society (CCS) grading of angina pectoris
CCS angina class
Canadian Cardiovascular Society (CCS) grading of angina pectoris
CCS angina class
Canadian Cardiovascular Society (CCS) grading of angina pectoris
CCS angina class
Canadian Cardiovascular Society (CCS) grading of angina pectoris
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
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
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
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)
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)
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)
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
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
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
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
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
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
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)
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)
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)
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
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
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
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
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)
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)
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
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
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

Full Information

First Posted
May 28, 2017
Last Updated
June 20, 2023
Sponsor
Aarhus University Hospital Skejby
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT03171311
Brief Title
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Acronym
OCTOBER
Official Title
European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction - The OCTOBER Trial -
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 5, 2017 (Actual)
Primary Completion Date
March 25, 2022 (Actual)
Study Completion Date
May 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Abbott

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischaemic Heart Disease, Ischemic Heart Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Angiographic guided PCI
Arm Type
Active Comparator
Arm Description
Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).
Arm Title
OCT guided PCI
Arm Type
Experimental
Arm Description
OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
Intervention Type
Procedure
Intervention Name(s)
Angiographic guided PCI
Other Intervention Name(s)
PCI, percutaneous transluminal coronary angioplasty (PTCA)
Intervention Description
Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques
Intervention Type
Procedure
Intervention Name(s)
OCT guided PCI
Other Intervention Name(s)
OCT
Intervention Description
OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans
Primary Outcome Measure Information:
Title
Combined endpoint of major adverse cardiac events (MACE)
Description
Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Study bifurcation oriented composite endpoint
Description
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Time Frame
1 month
Title
Study bifurcation oriented composite endpoint
Description
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Time Frame
12 months
Title
Study bifurcation oriented composite endpoint
Description
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Time Frame
24 months
Title
Study bifurcation oriented composite endpoint
Description
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Time Frame
36 months
Title
Study bifurcation oriented composite endpoint
Description
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Time Frame
48 months
Title
Study bifurcation oriented composite endpoint
Description
Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Time Frame
60 months
Title
Patient oriented composite endpoint
Description
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Time Frame
1 month
Title
Patient oriented composite endpoint
Description
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Time Frame
12 months
Title
Patient oriented composite endpoint
Description
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Time Frame
24 months
Title
Patient oriented composite endpoint
Description
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Time Frame
36 months
Title
Patient oriented composite endpoint
Description
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Time Frame
48 months
Title
Patient oriented composite endpoint
Description
Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Time Frame
60 months
Title
All-cause mortality
Description
Death of any cause including cardiac deaths and non-natural causes of death
Time Frame
1 month
Title
All-cause mortality
Description
Death of any cause including cardiac deaths and non-natural causes of death
Time Frame
12 months
Title
All-cause mortality
Description
Death of any cause including cardiac deaths and non-natural causes of death
Time Frame
24 months
Title
All-cause mortality
Description
Death of any cause including cardiac deaths and non-natural causes of death
Time Frame
36 months
Title
All-cause mortality
Description
Death of any cause including cardiac deaths and non-natural causes of death
Time Frame
48 months
Title
All-cause mortality
Description
Death of any cause including cardiac deaths and non-natural causes of death
Time Frame
60 months
Title
All-cause mortality
Description
Death of any cause including cardiac deaths and non-natural causes of death
Time Frame
120 months
Title
Cardiac death
Description
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Time Frame
1 month
Title
Cardiac death
Description
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Time Frame
12 months
Title
Cardiac death
Description
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Time Frame
24 months
Title
Cardiac death
Description
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Time Frame
36 months
Title
Cardiac death
Description
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Time Frame
48 months
Title
Cardiac death
Description
Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Time Frame
60 months
Title
Myocardial infarction
Description
Procedure and non-procedure related myocardial infarction
Time Frame
1 month
Title
Myocardial infarction
Description
Procedure and non-procedure related myocardial infarction
Time Frame
12 months
Title
Myocardial infarction
Description
Procedure and non-procedure related myocardial infarction
Time Frame
24 months
Title
Myocardial infarction
Description
Procedure and non-procedure related myocardial infarction
Time Frame
36 months
Title
Myocardial infarction
Description
Procedure and non-procedure related myocardial infarction
Time Frame
48 months
Title
Myocardial infarction
Description
Procedure and non-procedure related myocardial infarction
Time Frame
60 months
Title
Stent Thrombosis
Description
Definite, possible or probable
Time Frame
1 month
Title
Stent Thrombosis
Description
Definite, possible or probable
Time Frame
12 months
Title
Stent Thrombosis
Description
Definite, possible or probable
Time Frame
24 months
Title
Stent Thrombosis
Description
Definite, possible or probable
Time Frame
36 months
Title
Stent Thrombosis
Description
Definite, possible or probable
Time Frame
48 months
Title
Stent Thrombosis
Description
Definite, possible or probable
Time Frame
60 months
Title
Target lesion myocardial infarction
Description
Myocardial infarction related to an index treated lesion
Time Frame
1 month
Title
Target lesion myocardial infarction
Description
Myocardial infarction related to an index treated lesion
Time Frame
12 months
Title
Target lesion myocardial infarction
Description
Myocardial infarction related to an index treated lesion
Time Frame
24 months
Title
Target lesion myocardial infarction
Description
Myocardial infarction related to an index treated lesion
Time Frame
36 months
Title
Target lesion myocardial infarction
Description
Myocardial infarction related to an index treated lesion
Time Frame
48 months
Title
Target lesion myocardial infarction
Description
Myocardial infarction related to an index treated lesion
Time Frame
60 months
Title
Target lesion revascularisation
Description
Coronary artery bypass grafting or PCI of target lesion
Time Frame
1 month
Title
Target lesion revascularisation
Description
Coronary artery bypass grafting or PCI of target lesion
Time Frame
12 months
Title
Target lesion revascularisation
Description
Coronary artery bypass grafting or PCI of target lesion
Time Frame
24 months
Title
Target lesion revascularisation
Description
Coronary artery bypass grafting or PCI of target lesion
Time Frame
36 months
Title
Target lesion revascularisation
Description
Coronary artery bypass grafting or PCI of target lesion
Time Frame
48 months
Title
Target lesion revascularisation
Description
Coronary artery bypass grafting or PCI of target lesion
Time Frame
60 months
Title
Target bifurcation myocardial infarction
Description
Myocardial infarction related to the index bifurcation
Time Frame
1 month
Title
Target bifurcation myocardial infarction
Description
Myocardial infarction related to the index bifurcation
Time Frame
12 months
Title
Target bifurcation myocardial infarction
Description
Myocardial infarction related to the index bifurcation
Time Frame
24 months
Title
Target bifurcation myocardial infarction
Description
Myocardial infarction related to the index bifurcation
Time Frame
36 months
Title
Target bifurcation myocardial infarction
Description
Myocardial infarction related to the index bifurcation
Time Frame
48 months
Title
Target bifurcation myocardial infarction
Description
Myocardial infarction related to the index bifurcation
Time Frame
60 months
Title
Target bifurcation revascularisation
Description
Coronary artery bypass grafting or PCI of target bifurcation
Time Frame
1 month
Title
Target bifurcation revascularisation
Description
Coronary artery bypass grafting or PCI of target bifurcation
Time Frame
12 months
Title
Target bifurcation revascularisation
Description
Coronary artery bypass grafting or PCI of target bifurcation
Time Frame
24 months
Title
Target bifurcation revascularisation
Description
Coronary artery bypass grafting or PCI of target bifurcation
Time Frame
36 months
Title
Target bifurcation revascularisation
Description
Coronary artery bypass grafting or PCI of target bifurcation
Time Frame
48 months
Title
Target bifurcation revascularisation
Description
Coronary artery bypass grafting or PCI of target bifurcation
Time Frame
60 months
Title
Target vessel revascularisation
Description
Coronary artery bypass grafting or PCI of target vessel
Time Frame
1 month
Title
Target vessel revascularisation
Description
Coronary artery bypass grafting or PCI of target vessel
Time Frame
12 months
Title
Target vessel revascularisation
Description
Coronary artery bypass grafting or PCI of target vessel
Time Frame
24 months
Title
Target vessel revascularisation
Description
Coronary artery bypass grafting or PCI of target vessel
Time Frame
36 months
Title
Target vessel revascularisation
Description
Coronary artery bypass grafting or PCI of target vessel
Time Frame
48 months
Title
Target vessel revascularisation
Description
Coronary artery bypass grafting or PCI of target vessel
Time Frame
60 months
Title
Any revascularisation
Description
Any repeat revascularization except staged revascularization planned during the index procedure
Time Frame
1 month
Title
Any revascularisation
Description
Any repeat revascularization except staged revascularization planned during the index procedure
Time Frame
12 months
Title
Any revascularisation
Description
Any repeat revascularization except staged revascularization planned during the index procedure
Time Frame
24 months
Title
Any revascularisation
Description
Any repeat revascularization except staged revascularization planned during the index procedure
Time Frame
36 months
Title
Any revascularisation
Description
Any repeat revascularization except staged revascularization planned during the index procedure
Time Frame
48 months
Title
Any revascularisation
Description
Any repeat revascularization except staged revascularization planned during the index procedure
Time Frame
60 months
Title
CCS angina class
Description
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Time Frame
1 month
Title
CCS angina class
Description
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Time Frame
12 months
Title
CCS angina class
Description
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Time Frame
24 months
Title
CCS angina class
Description
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Time Frame
36 months
Title
CCS angina class
Description
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Time Frame
48 months
Title
CCS angina class
Description
Canadian Cardiovascular Society (CCS) grading of angina pectoris
Time Frame
60 months
Title
Post-PCI minimal lumen diameter in the stented proximal main vessel segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented proximal main vessel segment
Time Frame
1 day
Title
Post-PCI minimal lumen diameter in the stented distal main vessel segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel segment
Time Frame
1 day
Title
Post-PCI minimal lumen diameter in the treated side branch vessel segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment
Time Frame
1 day
Title
Post-PCI minimal lumen diameter in the proximal main vessel edge segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)
Time Frame
1 day
Title
Post-PCI minimal lumen diameter in the distal main vessel edge segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)
Time Frame
1 day
Title
Post-PCI minimal lumen diameter in the side branch vessel edge segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)
Time Frame
1 day
Title
Post-PCI minimal lumen diameter in the stented bifurcation core segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented bifurcation core segment
Time Frame
1 day
Title
Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment
Time Frame
1 day
Title
Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated side branch vessel ostium segment
Time Frame
1 day
Title
Post-PCI diameter stenosis in the stented proximal main vessel segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented proximal main vessel segment
Time Frame
1 day
Title
Post-PCI diameter stenosis in the stented distal main vessel segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel segment
Time Frame
1 day
Title
Post-PCI diameter stenosis in the treated side branch vessel segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment
Time Frame
1 day
Title
Post-PCI diameter stenosis in the proximal main vessel edge segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)
Time Frame
1 day
Title
Post-PCI diameter stenosis in the distal main vessel edge segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)
Time Frame
1 day
Title
Post-PCI diameter stenosis in the side branch vessel edge segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)
Time Frame
1 day
Title
Post-PCI diameter stenosis in the stented bifurcation core segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented bifurcation core segment
Time Frame
1 day
Title
Post-PCI diameter stenosis in the stented distal main vessel ostium segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment
Time Frame
1 day
Title
Post-PCI diameter stenosis in the treated side branch ostium segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated side branch ostium segment
Time Frame
1 day
Title
Post-PCI minimal lumen diameter in non-bifurcation target stented segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target stented segment
Time Frame
1 day
Title
Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment (within 5mm fra stent)
Time Frame
1 day
Title
Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment
Description
Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment (within 5mm fra stent)
Time Frame
1 day
Title
Post-PCI diameter stenosis in non-bifurcation target stented segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target stented segment
Time Frame
1 day
Title
Post-PCI diameter stenosis in non-bifurcation target proximal edge segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment
Time Frame
1 day
Title
Post-PCI diameter stenosis in non-bifurcation target distal edge segment
Description
Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evald H Christiansen, MD, PhD
Organizational Affiliation
Aarhus University Hospital, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg (ZOL) Genk
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Leuven University Hospital
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Aalborg University Hospital
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Aarhus University Hospital Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Gentofte Hospital
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Rigshospitalet
City
København Ø
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Zealand University Hospital, Roskilde Sygehus
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Estonia Medical Centre
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Vivantes Klinikum im Friedrichshain
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Cardiologicum Hamburg
City
Hamburg
ZIP/Postal Code
22041
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
University Hospital Galway
City
Galway
ZIP/Postal Code
H91YR71
Country
Ireland
Facility Name
Azienda Ospedaliero-Universitaria di Ferrara
City
Ferrara
State/Province
Cona
ZIP/Postal Code
44124
Country
Italy
Facility Name
Gemelli General Hospital, Catholic University of the Sacred Heart
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Latvia Centre of Cardiology
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Northwest Hospital Alkmaar
City
Alkmaar
ZIP/Postal Code
1815
Country
Netherlands
Facility Name
VU University Medical Center (VUMC)
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
St Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Hospital of Southern Norway, Arendal
City
Arendal
ZIP/Postal Code
4604
Country
Norway
Facility Name
Haukeland University Hospital, Bergen
City
Bergen
Country
Norway
Facility Name
Oslo University Hospital, Rikshospitalet
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Facility Name
Oslo University Hospital - Ullevål
City
Oslo
ZIP/Postal Code
0450
Country
Norway
Facility Name
Trondheim University Hospital
City
Trondheim
Country
Norway
Facility Name
Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Karolinska University Hospital Huddinge
City
Huddinge
State/Province
Stockholm
ZIP/Postal Code
14157
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Örebro University Hospital
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Belfast Health and Social Care Trust
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH77DW
Country
United Kingdom
Facility Name
Sussex Cardiac Centre
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Golden Jubilee Hospital
City
Glasgow
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
University Hospital South Manchester, Wythenshawe Hospital
City
Manchester
ZIP/Postal Code
M239LT
Country
United Kingdom
Facility Name
Morriston Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Is decided after primary endpoint assessment and requires regulatory approval
Citations:
PubMed Identifier
30205242
Citation
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.
Results Reference
derived

Learn more about this trial

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

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