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NCT03171311 Clinical Trial

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

Ischemic Heart Disease Clinical Trial

— OCTOBER  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03171311
Other study ID # 1-10-72-161-16
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 5, 2017
Est. completion date May 2029

Study information
Verified date June 2023
Source Aarhus University Hospital Skejby
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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

Description:

Coronary bifurcation lesions with stenosis in a large side branch may require complex stent implantation techniques with an elevated risk of suboptimal treatment results. Intra vascular optical coherence tomography (OCT) enables improved procedural control of correctable factors and may lead to optimized implantation results. It is unknown if routine, systematic use of OCT scans during complex bifurcation stenting improves clinical outcome but present available evidence indicates advantages of OCT guidance that could translate into improved clinical outcome. Hypothesis: Systematic OCT guided revascularization of patients with bifurcation lesions requiring complex stent implantation provides superior two-year clinical outcome compared to standard revascularization by PCI. Methods: Investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective, multicenter, superiority trial. Randomization is stratified for 1) Left main or non-Left main artery disease, and 2) up-front planned one-stent technique with kissing balloon inflation, or a two-stent technique. Systematic OCT guidance is detailed for five complex stent implantation techniques. Standard treatment is angiographic based with optional use of intravascular ultrasound (IVUS).

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Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Angiographic guided PCI
Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques
• OCT guided PCI
OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans
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Sponsors (2)
Lead Sponsor Collaborator
Aarhus University Hospital Skejby Abbott

Countries where clinical trial is conducted

Belgium,  Denmark,  Estonia,  Finland,  Germany,  Ireland,  Italy,  Latvia,  Netherlands,  Norway,  Poland,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Combined endpoint of major adverse cardiac events (MACE) Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization 24 months
Secondary Study bifurcation oriented composite endpoint Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation 1 month
Secondary Study bifurcation oriented composite endpoint Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation 12 months
Secondary Study bifurcation oriented composite endpoint Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation 24 months
Secondary Study bifurcation oriented composite endpoint Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation 36 months
Secondary Study bifurcation oriented composite endpoint Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation 48 months
Secondary Study bifurcation oriented composite endpoint Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation 60 months
Secondary Patient oriented composite endpoint Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke 1 month
Secondary Patient oriented composite endpoint Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke 12 months
Secondary Patient oriented composite endpoint Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke 24 months
Secondary Patient oriented composite endpoint Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke 36 months
Secondary Patient oriented composite endpoint Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke 48 months
Secondary Patient oriented composite endpoint Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke 60 months
Secondary All-cause mortality Death of any cause including cardiac deaths and non-natural causes of death 1 month
Secondary All-cause mortality Death of any cause including cardiac deaths and non-natural causes of death 12 months
Secondary All-cause mortality Death of any cause including cardiac deaths and non-natural causes of death 24 months
Secondary All-cause mortality Death of any cause including cardiac deaths and non-natural causes of death 36 months
Secondary All-cause mortality Death of any cause including cardiac deaths and non-natural causes of death 48 months
Secondary All-cause mortality Death of any cause including cardiac deaths and non-natural causes of death 60 months
Secondary All-cause mortality Death of any cause including cardiac deaths and non-natural causes of death 120 months
Secondary Cardiac death Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes 1 month
Secondary Cardiac death Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes 12 months
Secondary Cardiac death Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes 24 months
Secondary Cardiac death Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes 36 months
Secondary Cardiac death Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes 48 months
Secondary Cardiac death Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes 60 months
Secondary Myocardial infarction Procedure and non-procedure related myocardial infarction 1 month
Secondary Myocardial infarction Procedure and non-procedure related myocardial infarction 12 months
Secondary Myocardial infarction Procedure and non-procedure related myocardial infarction 24 months
Secondary Myocardial infarction Procedure and non-procedure related myocardial infarction 36 months
Secondary Myocardial infarction Procedure and non-procedure related myocardial infarction 48 months
Secondary Myocardial infarction Procedure and non-procedure related myocardial infarction 60 months
Secondary Stent Thrombosis Definite, possible or probable 1 month
Secondary Stent Thrombosis Definite, possible or probable 12 months
Secondary Stent Thrombosis Definite, possible or probable 24 months
Secondary Stent Thrombosis Definite, possible or probable 36 months
Secondary Stent Thrombosis Definite, possible or probable 48 months
Secondary Stent Thrombosis Definite, possible or probable 60 months
Secondary Target lesion myocardial infarction Myocardial infarction related to an index treated lesion 1 month
Secondary Target lesion myocardial infarction Myocardial infarction related to an index treated lesion 12 months
Secondary Target lesion myocardial infarction Myocardial infarction related to an index treated lesion 24 months
Secondary Target lesion myocardial infarction Myocardial infarction related to an index treated lesion 36 months
Secondary Target lesion myocardial infarction Myocardial infarction related to an index treated lesion 48 months
Secondary Target lesion myocardial infarction Myocardial infarction related to an index treated lesion 60 months
Secondary Target lesion revascularisation Coronary artery bypass grafting or PCI of target lesion 1 month
Secondary Target lesion revascularisation Coronary artery bypass grafting or PCI of target lesion 12 months
Secondary Target lesion revascularisation Coronary artery bypass grafting or PCI of target lesion 24 months
Secondary Target lesion revascularisation Coronary artery bypass grafting or PCI of target lesion 36 months
Secondary Target lesion revascularisation Coronary artery bypass grafting or PCI of target lesion 48 months
Secondary Target lesion revascularisation Coronary artery bypass grafting or PCI of target lesion 60 months
Secondary Target bifurcation myocardial infarction Myocardial infarction related to the index bifurcation 1 month
Secondary Target bifurcation myocardial infarction Myocardial infarction related to the index bifurcation 12 months
Secondary Target bifurcation myocardial infarction Myocardial infarction related to the index bifurcation 24 months
Secondary Target bifurcation myocardial infarction Myocardial infarction related to the index bifurcation 36 months
Secondary Target bifurcation myocardial infarction Myocardial infarction related to the index bifurcation 48 months
Secondary Target bifurcation myocardial infarction Myocardial infarction related to the index bifurcation 60 months
Secondary Target bifurcation revascularisation Coronary artery bypass grafting or PCI of target bifurcation 1 month
Secondary Target bifurcation revascularisation Coronary artery bypass grafting or PCI of target bifurcation 12 months
Secondary Target bifurcation revascularisation Coronary artery bypass grafting or PCI of target bifurcation 24 months
Secondary Target bifurcation revascularisation Coronary artery bypass grafting or PCI of target bifurcation 36 months
Secondary Target bifurcation revascularisation Coronary artery bypass grafting or PCI of target bifurcation 48 months
Secondary Target bifurcation revascularisation Coronary artery bypass grafting or PCI of target bifurcation 60 months
Secondary Target vessel revascularisation Coronary artery bypass grafting or PCI of target vessel 1 month
Secondary Target vessel revascularisation Coronary artery bypass grafting or PCI of target vessel 12 months
Secondary Target vessel revascularisation Coronary artery bypass grafting or PCI of target vessel 24 months
Secondary Target vessel revascularisation Coronary artery bypass grafting or PCI of target vessel 36 months
Secondary Target vessel revascularisation Coronary artery bypass grafting or PCI of target vessel 48 months
Secondary Target vessel revascularisation Coronary artery bypass grafting or PCI of target vessel 60 months
Secondary Any revascularisation Any repeat revascularization except staged revascularization planned during the index procedure 1 month
Secondary Any revascularisation Any repeat revascularization except staged revascularization planned during the index procedure 12 months
Secondary Any revascularisation Any repeat revascularization except staged revascularization planned during the index procedure 24 months
Secondary Any revascularisation Any repeat revascularization except staged revascularization planned during the index procedure 36 months
Secondary Any revascularisation Any repeat revascularization except staged revascularization planned during the index procedure 48 months
Secondary Any revascularisation Any repeat revascularization except staged revascularization planned during the index procedure 60 months
Secondary CCS angina class Canadian Cardiovascular Society (CCS) grading of angina pectoris 1 month
Secondary CCS angina class Canadian Cardiovascular Society (CCS) grading of angina pectoris 12 months
Secondary CCS angina class Canadian Cardiovascular Society (CCS) grading of angina pectoris 24 months
Secondary CCS angina class Canadian Cardiovascular Society (CCS) grading of angina pectoris 36 months
Secondary CCS angina class Canadian Cardiovascular Society (CCS) grading of angina pectoris 48 months
Secondary CCS angina class Canadian Cardiovascular Society (CCS) grading of angina pectoris 60 months
Secondary 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 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary 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) 1 day
Secondary 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) 1 day
Secondary 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) 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary 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) 1 day
Secondary 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) 1 day
Secondary 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) 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary 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) 1 day
Secondary 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) 1 day
Secondary 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 1 day
Secondary 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 1 day
Secondary 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 1 day
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