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Clinical Trials in Ireland / NCT03171311
Active, not recruiting

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

NCT03171311 · tracked via the Priya Life Science Ireland tracker
Sponsor
Aarhus University Hospital Skejby
Phase
N/A
Started
2017-07-05
Last updated
2026-05-18

Condition(s) studied

Ischaemic Heart DiseaseIschemic Heart Disease

Investigational drug(s) / intervention(s)

Angiographic guided PCIOCT guided PCI

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

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (38)

FacilityCityRegionStatus
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 State of Berlin
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
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
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03171311 on ClinicalTrials.gov ↗ ← All trials in Ireland