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
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1201
• Est. completion date: May 2029
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischaemic Heart Disease
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

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

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg (ZOL) Genk	Genk
Belgium	Leuven University Hospital	Leuven
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital Skejby	Aarhus N
Denmark	Gentofte Hospital	Gentofte
Denmark	Rigshospitalet	København Ø
Denmark	Odense University Hospital	Odense
Denmark	Zealand University Hospital, Roskilde Sygehus	Roskilde
Estonia	Estonia Medical Centre	Tallinn
Finland	Tampere University Hospital	Tampere
Germany	Vivantes Klinikum im Friedrichshain	Berlin
Germany	Cardiologicum Hamburg	Hamburg
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	Universitätsklinikum Schleswig-Holstein Campus Kiel	Kiel
Ireland	University Hospital Galway	Galway
Italy	Azienda Ospedaliero-Universitaria di Ferrara	Ferrara	Cona
Italy	Gemelli General Hospital, Catholic University of the Sacred Heart	Rome
Latvia	Latvia Centre of Cardiology	Riga
Netherlands	Northwest Hospital Alkmaar	Alkmaar
Netherlands	VU University Medical Center (VUMC)	Amsterdam
Netherlands	St Antonius Ziekenhuis	Nieuwegein
Norway	Hospital of Southern Norway, Arendal	Arendal
Norway	Haukeland University Hospital, Bergen	Bergen
Norway	Oslo University Hospital - Ullevål	Oslo
Norway	Oslo University Hospital, Rikshospitalet	Oslo
Norway	Trondheim University Hospital	Trondheim
Poland	Medical University of Warsaw	Warsaw
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Karolinska University Hospital Huddinge	Huddinge	Stockholm
Sweden	Örebro University Hospital	Orebro
Sweden	Södersjukhuset	Stockholm
United Kingdom	Belfast Health and Social Care Trust	Belfast
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Sussex Cardiac Centre	Brighton
United Kingdom	Golden Jubilee Hospital	Glasgow
United Kingdom	St George's Hospital	London
United Kingdom	University Hospital South Manchester, Wythenshawe Hospital	Manchester
United Kingdom	Morriston Hospital	Swansea

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