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

NCT03171311 | Active Not Recruiting DMC

• 1 other identifier: 1-10-72-161-16
• Study Type: interventional
• Target: 1,201
• Locations: 13 countries
• Sites: 38

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

Conditions

Ischaemic Heart Disease; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Combined endpoint of major adverse cardiac events (MACE)

  Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization

  24 months

Secondary Outcomes (103)

• Study bifurcation oriented composite endpoint

  1 month

• Study bifurcation oriented composite endpoint

  12 months

• Study bifurcation oriented composite endpoint

  24 months

• Study bifurcation oriented composite endpoint

  36 months

• Study bifurcation oriented composite endpoint

  48 months

Study Arms (2)

Angiographic guided PCI

ACTIVE COMPARATOR

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

Procedure: Angiographic guided PCI

OCT guided PCI

EXPERIMENTAL

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

Procedure: OCT guided PCI

Interventions

Angiographic guided PCI PROCEDURE

Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques

Also known as: PCI, percutaneous transluminal coronary angioplasty (PTCA)

Angiographic guided PCI

OCT guided PCI PROCEDURE

OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans

Also known as: OCT

OCT guided PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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).
• Severe tortuosity around target bifurcation
• Chronic total occlusions
• Massive thrombus in Left main coronary artery
• Medina 0.0.1 lesions

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead
• Abbott: collaborator

Study Sites (38)

Ziekenhuis Oost-Limburg (ZOL) Genk

Genk, 3600, Belgium

Location

Leuven University Hospital

Leuven, 3000, Belgium

Location

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Aarhus University Hospital Skejby

Aarhus N, 8200, Denmark

Location

Gentofte Hospital

Gentofte Municipality, 2820, Denmark

Location

Rigshospitalet

København Ø, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Zealand University Hospital, Roskilde Sygehus

Roskilde, 4000, Denmark

Location

Estonia Medical Centre

Tallinn, 13419, Estonia

Location

Tampere University Hospital

Tampere, 33520, Finland

Location

Vivantes Klinikum im Friedrichshain

Berlin, 10249, Germany

Location

Universitäres Herzzentrum Hamburg

Hamburg, 20246, Germany

Location

Cardiologicum Hamburg

Hamburg, 22041, Germany

Location

Universitätsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

University Hospital Galway

Galway, H91YR71, Ireland

Location

Azienda Ospedaliero-Universitaria di Ferrara

Ferrara, Cona, 44124, Italy

Location

Gemelli General Hospital, Catholic University of the Sacred Heart

Rome, 00168, Italy

Location

Latvia Centre of Cardiology

Riga, LV-1002, Latvia

Location

Northwest Hospital Alkmaar

Alkmaar, 1815, Netherlands

Location

VU University Medical Center (VUMC)

Amsterdam, 1081 HV, Netherlands

Location

St Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Hospital of Southern Norway, Arendal

Arendal, 4604, Norway

Location

Haukeland University Hospital, Bergen

Bergen, Norway

Location

Oslo University Hospital, Rikshospitalet

Oslo, 0424, Norway

Location

Oslo University Hospital - Ullevål

Oslo, 0450, Norway

Location

Trondheim University Hospital

Trondheim, Norway

Location

Medical University of Warsaw

Warsaw, 02-097, Poland

Location

Karolinska University Hospital Huddinge

Huddinge, Stockholm County, 14157, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Örebro University Hospital

Örebro, 70185, Sweden

Location

Södersjukhuset

Stockholm, 118 83, Sweden

Location

Belfast Health and Social Care Trust

Belfast, BT9 7AB, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH77DW, United Kingdom

Location

Sussex Cardiac Centre

Brighton, BN2 5BE, United Kingdom

Location

Golden Jubilee Hospital

Glasgow, G81 4DY, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

University Hospital South Manchester, Wythenshawe Hospital

Manchester, M239LT, United Kingdom

Location

Morriston Hospital

Swansea, SA6 6NL, United Kingdom

Location

Related Publications (2)

• Holm NR, Andreasen LD, 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.

  PMID: 37634149 DERIVED

• 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.

  PMID: 30205242 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Interventions

Angioplasty, Balloon, Coronary

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty, Balloon; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques

Study Officials

• Evald H Christiansen, MD, PhD

  Aarhus University Hospital, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, phd

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: May 31, 2017
• Study Start: July 5, 2017
• Primary Completion: March 25, 2022
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

FI (1); LA (1); IE (1); ES (1); IT (2); DE (4); DK (6); BE (2); NO (5); NL (3); PL (1); SE (4); GB (7)