The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
NCT ID: NCT03171311
Last Updated: 2023-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1201 participants
INTERVENTIONAL
2017-07-05
2029-05-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Angiographic guided PCI
Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).
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 systematic use of intravascular optical coherence tomography (OCT)
OCT guided PCI
OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age ≥18 yrs.
* Abel to provide written Informed consent and willing to comply with the specified follow-up contacts.
* 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 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.
Indication for two-stent technique or one-stent technique with kissing balloon inflation
Exclusion Criteria
* 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).
* Severe tortuosity around target bifurcation
* Chronic total occlusions
* Massive thrombus in Left main coronary artery
* Medina 0.0.1 lesions
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
Aarhus University Hospital Skejby
OTHER
Responsible Party
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Evald Hoej Christiansen
MD, phd
Principal Investigators
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Evald H Christiansen, MD, PhD
Role: STUDY_CHAIR
Aarhus University Hospital, Denmark
Locations
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Ziekenhuis Oost-Limburg (ZOL) Genk
Genk, , Belgium
Leuven University Hospital
Leuven, , Belgium
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital Skejby
Aarhus N, , Denmark
Gentofte Hospital
Gentofte Municipality, , Denmark
Rigshospitalet
København Ø, , Denmark
Odense University Hospital
Odense, , Denmark
Zealand University Hospital, Roskilde Sygehus
Roskilde, , Denmark
Estonia Medical Centre
Tallinn, , Estonia
Tampere University Hospital
Tampere, , Finland
Vivantes Klinikum im Friedrichshain
Berlin, , Germany
Universitäres Herzzentrum Hamburg
Hamburg, , Germany
Cardiologicum Hamburg
Hamburg, , Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, , Germany
University Hospital Galway
Galway, , Ireland
Azienda Ospedaliero-Universitaria di Ferrara
Ferrara, Cona, Italy
Gemelli General Hospital, Catholic University of the Sacred Heart
Rome, , Italy
Latvia Centre of Cardiology
Riga, , Latvia
Northwest Hospital Alkmaar
Alkmaar, , Netherlands
VU University Medical Center (VUMC)
Amsterdam, , Netherlands
St Antonius Ziekenhuis
Nieuwegein, , Netherlands
Hospital of Southern Norway, Arendal
Arendal, , Norway
Haukeland University Hospital, Bergen
Bergen, , Norway
Oslo University Hospital, Rikshospitalet
Oslo, , Norway
Oslo University Hospital - Ullevål
Oslo, , Norway
Trondheim University Hospital
Trondheim, , Norway
Medical University of Warsaw
Warsaw, , Poland
Karolinska University Hospital Huddinge
Huddinge, Stockholm County, Sweden
Sahlgrenska University Hospital
Gothenburg, , Sweden
Örebro University Hospital
Örebro, , Sweden
Södersjukhuset
Stockholm, , Sweden
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, , United Kingdom
Countries
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References
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Holm NR, Andreasen LN, Neghabat O, Laanmets P, Kumsars I, Bennett J, Olsen NT, Odenstedt J, Hoffmann P, Dens J, Chowdhary S, O'Kane P, Bulow Rasmussen SH, Heigert M, Havndrup O, Van Kuijk JP, Biscaglia S, Mogensen LJH, Henareh L, Burzotta F, H Eek C, Mylotte D, Llinas MS, Koltowski L, Knaapen P, Calic S, Witt N, Santos-Pardo I, Watkins S, Lonborg J, Kristensen AT, Jensen LO, Calais F, Cockburn J, McNeice A, Kajander OA, Heestermans T, Kische S, Eftekhari A, Spratt JC, Christiansen EH; OCTOBER Trial Group. OCT or Angiography Guidance for PCI in Complex Bifurcation Lesions. N Engl J Med. 2023 Oct 19;389(16):1477-1487. doi: 10.1056/NEJMoa2307770. Epub 2023 Aug 27.
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.
Other Identifiers
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1-10-72-161-16
Identifier Type: -
Identifier Source: org_study_id
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