The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER) (OCTOBER)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03171311 |
|
Recruitment Status :
Recruiting
First Posted : May 31, 2017
Last Update Posted : February 16, 2022
|
Sponsor:
Aarhus University Hospital Skejby
Collaborator:
Abbott
Information provided by (Responsible Party):
Evald Hoej Christiansen, Aarhus University Hospital Skejby
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ischaemic Heart Disease Ischemic Heart Disease | Procedure: Angiographic guided PCI Procedure: OCT guided PCI | Not Applicable |
Coronary bifurcation lesions with stenosis in a large side branch may require complex stent implantation techniques with an elevated risk of suboptimal treatment results. Intra vascular optical coherence tomography (OCT) enables improved procedural control of correctable factors and may lead to optimized implantation results.
It is unknown if routine, systematic use of OCT scans during complex bifurcation stenting improves clinical outcome but present available evidence indicates advantages of OCT guidance that could translate into improved clinical outcome.
Hypothesis: Systematic OCT guided revascularization of patients with bifurcation lesions requiring complex stent implantation provides superior two-year clinical outcome compared to standard revascularization by PCI.
Methods: Investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective, multicenter, superiority trial. Randomization is stratified for 1) Left main or non-Left main artery disease, and 2) up-front planned one-stent technique with kissing balloon inflation, or a two-stent technique.
Systematic OCT guidance is detailed for five complex stent implantation techniques. Standard treatment is angiographic based with optional use of intravascular ultrasound (IVUS).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1200 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction - The OCTOBER Trial - |
| Actual Study Start Date : | July 5, 2017 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | May 2029 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Angiographic guided PCI
Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).
|
Procedure: Angiographic guided PCI
Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques
Other Name: PCI, percutaneous transluminal coronary angioplasty (PTCA) |
|
Experimental: OCT guided PCI
OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
|
Procedure: OCT guided PCI
OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans
Other Name: OCT |
Primary Outcome Measures :
- Combined endpoint of major adverse cardiovascular events (MACE) [ Time Frame: 24 months ]cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization
Secondary Outcome Measures :
- Study bifurcation oriented composite endpoint of MACE [ Time Frame: 1 month ]Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
- Study bifurcation oriented composite endpoint of MACE [ Time Frame: 12 months ]Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
- Study bifurcation oriented composite endpoint of MACE [ Time Frame: 24 months ]Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
- Study bifurcation oriented composite endpoint of MACE [ Time Frame: 36 months ]Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
- Study bifurcation oriented composite endpoint of MACE [ Time Frame: 48 months ]Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
- Study bifurcation oriented composite endpoint of MACE [ Time Frame: 60 months ]Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
- Patient oriented composite endpoint endpoint of MACE [ Time Frame: 1 month ]All cause mortality, myocardial infarction, any revascularisation, stroke
- Patient oriented composite endpoint endpoint of MACE [ Time Frame: 12 months ]All cause mortality, myocardial infarction, any revascularisation, stroke
- Patient oriented composite endpoint endpoint of MACE [ Time Frame: 24 months ]All cause mortality, myocardial infarction, any revascularisation, stroke
- Patient oriented composite endpoint endpoint of MACE [ Time Frame: 36 months ]All cause mortality, myocardial infarction, any revascularisation, stroke
- Patient oriented composite endpoint endpoint of MACE [ Time Frame: 48 months ]All cause mortality, myocardial infarction, any revascularisation, stroke
- Patient oriented composite endpoint endpoint of MACE [ Time Frame: 60 months ]All cause mortality, myocardial infarction, any revascularisation, stroke
- All-cause mortality [ Time Frame: 1 month ]Death of any cause including cardiac deaths and non-natural causes of death
- All-cause mortality [ Time Frame: 12 months ]Death of any cause including cardiac deaths and non-natural causes of death
- All-cause mortality [ Time Frame: 24 months ]Death of any cause including cardiac deaths and non-natural causes of death
- All-cause mortality [ Time Frame: 36 months ]Death of any cause including cardiac deaths and non-natural causes of death
- All-cause mortality [ Time Frame: 48 months ]Death of any cause including cardiac deaths and non-natural causes of death
- All-cause mortality [ Time Frame: 60 months ]Death of any cause including cardiac deaths and non-natural causes of death
- All-cause mortality [ Time Frame: 120 months ]Death of any cause including cardiac deaths and non-natural causes of death
- Cardiac death [ Time Frame: 1 month ]Death due to cardiovascular disease
- Cardiac death [ Time Frame: 12 months ]Death due to cardiovascular disease
- Cardiac death [ Time Frame: 24 months ]Death due to cardiovascular disease
- Cardiac death [ Time Frame: 36 months ]Death due to cardiovascular disease
- Cardiac death [ Time Frame: 48 months ]Death due to cardiovascular disease
- Cardiac death [ Time Frame: 60 months ]Death due to cardiovascular disease
- Myocardial infarction [ Time Frame: 1 month ]Procedure and non-procedure related myocardial infarction
- Myocardial infarction [ Time Frame: 12 months ]Procedure and non-procedure related myocardial infarction
- Myocardial infarction [ Time Frame: 24 months ]Procedure and non-procedure related myocardial infarction
- Myocardial infarction [ Time Frame: 36 months ]Procedure and non-procedure related myocardial infarction
- Myocardial infarction [ Time Frame: 48 months ]Procedure and non-procedure related myocardial infarction
- Myocardial infarction [ Time Frame: 60 months ]Procedure and non-procedure related myocardial infarction
- Stent Thrombosis [ Time Frame: 1 month ]Definite, possible or probable
- Stent Thrombosis [ Time Frame: 12 months ]Definite, possible or probable
- Stent Thrombosis [ Time Frame: 24 months ]Definite, possible or probable
- Stent Thrombosis [ Time Frame: 36 months ]Definite, possible or probable
- Stent Thrombosis [ Time Frame: 48 months ]Definite, possible or probable
- Stent Thrombosis [ Time Frame: 60 months ]Definite, possible or probable
- Target lesion myocardial infarction [ Time Frame: 1 month ]Myocardial infarction related to an index treated lesion
- Target lesion myocardial infarction [ Time Frame: 12 months ]Myocardial infarction related to an index treated lesion
- Target lesion myocardial infarction [ Time Frame: 24 months ]Myocardial infarction related to an index treated lesion
- Target lesion myocardial infarction [ Time Frame: 36 months ]Myocardial infarction related to an index treated lesion
- Target lesion myocardial infarction [ Time Frame: 48 months ]Myocardial infarction related to an index treated lesion
- Target lesion myocardial infarction [ Time Frame: 60 months ]Myocardial infarction related to an index treated lesion
- Target lesion revascularisation [ Time Frame: 1 month ]Coronary artery bypass grafting or PCI of index lesion
- Target lesion revascularisation [ Time Frame: 12 months ]Coronary artery bypass grafting or PCI of index lesion
- Target lesion revascularisation [ Time Frame: 24 months ]Coronary artery bypass grafting or PCI of index lesion
- Target lesion revascularisation [ Time Frame: 36 months ]Coronary artery bypass grafting or PCI of index lesion
- Target lesion revascularisation [ Time Frame: 48 months ]Coronary artery bypass grafting or PCI of index lesion
- Target lesion revascularisation [ Time Frame: 60 months ]Coronary artery bypass grafting or PCI of index lesion
- Target bifurcation myocardial infarction [ Time Frame: 1 month ]Myocardial infarction related to the index bifurcation
- Target bifurcation myocardial infarction [ Time Frame: 12 months ]Myocardial infarction related to the index bifurcation
- Target bifurcation myocardial infarction [ Time Frame: 24 months ]Myocardial infarction related to the index bifurcation
- Target bifurcation myocardial infarction [ Time Frame: 36 months ]Myocardial infarction related to the index bifurcation
- Target bifurcation myocardial infarction [ Time Frame: 48 months ]Myocardial infarction related to the index bifurcation
- Target bifurcation myocardial infarction [ Time Frame: 60 months ]Myocardial infarction related to the index bifurcation
- Target bifurcation revascularisation [ Time Frame: 1 month ]Coronary artery bypass grafting or PCI of index bifurcation
- Target bifurcation revascularisation [ Time Frame: 12 months ]Coronary artery bypass grafting or PCI of index bifurcation
- Target bifurcation revascularisation [ Time Frame: 24 months ]Coronary artery bypass grafting or PCI of index bifurcation
- Target bifurcation revascularisation [ Time Frame: 36 months ]Coronary artery bypass grafting or PCI of index bifurcation
- Target bifurcation revascularisation [ Time Frame: 48 months ]Coronary artery bypass grafting or PCI of index bifurcation
- Target bifurcation revascularisation [ Time Frame: 60 months ]Coronary artery bypass grafting or PCI of index bifurcation
- Target vessel revascularisation [ Time Frame: 1 month ]Coronary artery bypass grafting or PCI related to target vessel lesion
- Target vessel revascularisation [ Time Frame: 12 months ]Coronary artery bypass grafting or PCI related to target vessel lesion
- Target vessel revascularisation [ Time Frame: 36 months ]Coronary artery bypass grafting or PCI related to target vessel lesion
- Target vessel revascularisation [ Time Frame: 48 months ]Coronary artery bypass grafting or PCI related to target vessel lesion
- Target vessel revascularisation [ Time Frame: 60 months ]Coronary artery bypass grafting or PCI related to target vessel lesion
- Any revascularisation [ Time Frame: 1 month ]Any repeat revascularization except staged procedures planned at the index procedure
- Any revascularisation [ Time Frame: 12 months ]Any repeat revascularization except staged procedures planned at the index procedure
- Any revascularisation [ Time Frame: 24 months ]Any repeat revascularization except staged procedures planned at the index procedure
- Any revascularisation [ Time Frame: 36 months ]Any repeat revascularization except staged procedures planned at the index procedure
- Any revascularisation [ Time Frame: 48 months ]Any repeat revascularization except staged procedures planned at the index procedure
- Any revascularisation [ Time Frame: 60 months ]Any repeat revascularization except staged procedures planned at the index procedure
- CCS angina class [ Time Frame: 1 month ]Canadian Cardiovascular Society (CCS) grading of angina pectoris
- CCS angina class [ Time Frame: 12 months ]Canadian Cardiovascular Society (CCS) grading of angina pectoris
- CCS angina class [ Time Frame: 24 months ]Canadian Cardiovascular Society (CCS) grading of angina pectoris
- CCS angina class [ Time Frame: 36 months ]Canadian Cardiovascular Society (CCS) grading of angina pectoris
- CCS angina class [ Time Frame: 48 months ]Canadian Cardiovascular Society (CCS) grading of angina pectoris
- CCS angina class [ Time Frame: 60 months ]Canadian Cardiovascular Society (CCS) grading of angina pectoris
- NYHA class [ Time Frame: 1 month ]New York Heart Association (NYHA) Functional Classification
- NYHA class [ Time Frame: 12 months ]New York Heart Association (NYHA) Functional Classification
- NYHA class [ Time Frame: 24 months ]New York Heart Association (NYHA) Functional Classification
- NYHA class [ Time Frame: 36 months ]New York Heart Association (NYHA) Functional Classification
- NYHA class [ Time Frame: 48 months ]New York Heart Association (NYHA) Functional Classification
- NYHA class [ Time Frame: 60 months ]New York Heart Association (NYHA) Functional Classification
- Minimal lumen area in proximal main vessel segment [ Time Frame: 1 day ]Minimal lumen area by 3D quantitative coronary analysis (QCA) in the stented segment including edge just proximal to the target bifurcation
- Minimal lumen area in distal main vessel segment [ Time Frame: 1 day ]Minimal lumen area by 3D quantitative coronary analysis (QCA) in the stented segment including edge just distal to the target bifurcation
- Minimal lumen area in the side branch segment [ Time Frame: 1 day ]Minimal lumen area by 3D quantitative coronary analysis (QCA) in the proximal stented or balloon treated side branch segment including edge, of the target bifurcation
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Stable angina pectoris, unstable angina pectoris, clinically stable non-STEMI.
- Age ≥18 yrs.
- Abel to provide written Informed consent and willing to comply with the specified follow-up contacts.
Angiographic inclusion criteria:
- Native coronary bifurcation de novo lesion
- More than 50% diameter stenosis in the main vessel (MV)
- More than 50% diameter stenosis in the side branch (SB) within 5 mm of the ostium.
- Reference size at least 2.75 mm in the main vessel (MV) and ≥2.5 mm in the SB.
Functional inclusion criteria:
Functional significance of the main vessel lesion or documented ischemia of the main vessel territory or other objective documentation of lesion significance. Objective evidence of ischemia is required for all treated lesions except for lesions with more than 80% diameter stenosis that may be considered significant.
Procedural inclusion criteria:
Indication for two-stent technique or one-stent technique with kissing balloon inflation
Exclusion Criteria:
- STEMI within 72 hours
- Cardiogenic shock
- Prior coronary artery bypass grafting (CABG) or planned CABG
- Renal failure with glomerular filtration rate (GFR) <50 mL/min per 1.73 m2
- Active bleeding or coagulopathy
- Life expectancy < 2 years
- Ejection fraction < 30%
- New York Heart Association (NYHA) class > II
- Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus).
Angiographic exclusion criteria:
- Severe tortuosity around target bifurcation
- Chronic total occlusions
- Massive thrombus in Left main coronary artery
- Medina 0.0.1 lesions
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171311
Contacts
| Contact: Evald H Christiansen, MD, PhD | +4578450000 ext 52028 | evald.christiansen@dadlnet.dk | |
| Contact: Niels R Holm, MD | +4578450000 ext 52054 | niels.holm@clin.au.dk |
Locations
Show 40 study locations
Sponsors and Collaborators
Aarhus University Hospital Skejby
Abbott
Investigators
| Study Chair: | Evald H Christiansen, MD, PhD | Aarhus University Hospital, Denmark |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Evald Hoej Christiansen, MD, phd, Aarhus University Hospital Skejby |
| ClinicalTrials.gov Identifier: | NCT03171311 |
| Other Study ID Numbers: |
1-10-72-161-16 |
| First Posted: | May 31, 2017 Key Record Dates |
| Last Update Posted: | February 16, 2022 |
| Last Verified: | February 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Is decided after primary endpoint assessment and requires regulatory approval |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Heart Diseases Myocardial Ischemia Coronary Artery Disease Ischemia Pathologic Processes |
Cardiovascular Diseases Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |