The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
- Conditions
- Ischemic Heart DiseaseIschaemic Heart Disease
- Interventions
- Procedure: OCT guided PCIProcedure: Angiographic guided PCI
- Registration Number
- NCT03171311
- Lead Sponsor
- Aarhus University Hospital Skejby
- 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
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1201
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description OCT guided PCI OCT guided PCI OCT guided PCI is percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT) Angiographic guided PCI Angiographic guided PCI Angiographic guided PCI is revascularization by percutaneous coronary intervention (PCI) and optional use of intravascular ultrasound (IVUS).
- Primary Outcome Measures
Name Time Method Combined endpoint of major adverse cardiac events (MACE) 24 months Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization
- Secondary Outcome Measures
Name Time Method CCS angina class 60 months Canadian Cardiovascular Society (CCS) grading of angina pectoris
Any revascularisation 60 months Any repeat revascularization except staged revascularization planned during the index procedure
Post-PCI minimal lumen diameter in the side branch vessel edge segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)
Study bifurcation oriented composite endpoint 60 months Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation
Stent Thrombosis 60 months Definite, possible or probable
Target bifurcation myocardial infarction 60 months Myocardial infarction related to the index bifurcation
Post-PCI minimal lumen diameter in the stented proximal main vessel segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented proximal main vessel segment
Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment
Post-PCI diameter stenosis in the stented proximal main vessel segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented proximal main vessel segment
Cardiac death 60 months Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes
Myocardial infarction 60 months Procedure and non-procedure related myocardial infarction
Target vessel revascularisation 60 months Coronary artery bypass grafting or PCI of target vessel
Target lesion myocardial infarction 60 months Myocardial infarction related to an index treated lesion
Target lesion revascularisation 60 months Coronary artery bypass grafting or PCI of target lesion
Post-PCI minimal lumen diameter in the treated side branch vessel segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment
Post-PCI minimal lumen diameter in the stented bifurcation core segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented bifurcation core segment
Post-PCI diameter stenosis in non-bifurcation target distal edge segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment
Patient oriented composite endpoint 60 months Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke
Post-PCI minimal lumen diameter in the proximal main vessel edge segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)
Post-PCI diameter stenosis in the stented distal main vessel segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel segment
Post-PCI diameter stenosis in the treated side branch vessel segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment
Post-PCI diameter stenosis in the stented bifurcation core segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented bifurcation core segment
Post-PCI diameter stenosis in the treated side branch ostium segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated side branch ostium segment
Post-PCI minimal lumen diameter in non-bifurcation target stented segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target stented segment
Post-PCI diameter stenosis in non-bifurcation target stented segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target stented segment
All-cause mortality 120 months Death of any cause including cardiac deaths and non-natural causes of death
Target bifurcation revascularisation 60 months Coronary artery bypass grafting or PCI of target bifurcation
Post-PCI minimal lumen diameter in the stented distal main vessel segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel segment
Post-PCI minimal lumen diameter in the distal main vessel edge segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)
Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated side branch vessel ostium segment
Post-PCI diameter stenosis in the proximal main vessel edge segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent)
Post-PCI diameter stenosis in the side branch vessel edge segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon)
Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment (within 5mm fra stent)
Post-PCI diameter stenosis in the distal main vessel edge segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent)
Post-PCI diameter stenosis in the stented distal main vessel ostium segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment
Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment 1 day Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment (within 5mm fra stent)
Post-PCI diameter stenosis in non-bifurcation target proximal edge segment 1 day Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment
Trial Locations
- Locations (38)
Ziekenhuis Oost-Limburg (ZOL) Genk
🇧🇪Genk, Belgium
Leuven University Hospital
🇧🇪Leuven, Belgium
Cardiologicum Hamburg
🇩🇪Hamburg, Germany
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, Denmark
Tampere University Hospital
🇫🇮Tampere, Finland
Estonia Medical Centre
🇪🇪Tallinn, Estonia
Vivantes Klinikum im Friedrichshain
🇩🇪Berlin, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Germany
Universitäres Herzzentrum Hamburg
🇩🇪Hamburg, Germany
University Hospital Galway
🇮🇪Galway, Ireland
Azienda Ospedaliero-Universitaria di Ferrara
🇮🇹Ferrara, Cona, Italy
Northwest Hospital Alkmaar
🇳🇱Alkmaar, Netherlands
Gemelli General Hospital, Catholic University of the Sacred Heart
🇮🇹Rome, Italy
Latvia Centre of Cardiology
🇱🇻Riga, Latvia
Hospital of Southern Norway, Arendal
🇳🇴Arendal, Norway
VU University Medical Center (VUMC)
🇳🇱Amsterdam, Netherlands
St Antonius Ziekenhuis
🇳🇱Nieuwegein, Netherlands
Oslo University Hospital, Rikshospitalet
🇳🇴Oslo, Norway
Haukeland University Hospital, Bergen
🇳🇴Bergen, Norway
Oslo University Hospital - Ullevål
🇳🇴Oslo, Norway
Medical University of Warsaw
🇵🇱Warsaw, Poland
Södersjukhuset
🇸🇪Stockholm, Sweden
Trondheim University Hospital
🇳🇴Trondheim, Norway
Karolinska University Hospital Huddinge
🇸🇪Huddinge, Stockholm, Sweden
Sahlgrenska University Hospital
🇸🇪Göteborg, Sweden
Örebro University Hospital
🇸🇪Orebro, Sweden
Sussex Cardiac Centre
🇬🇧Brighton, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Golden Jubilee Hospital
🇬🇧Glasgow, United Kingdom
University Hospital South Manchester, Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Morriston Hospital
🇬🇧Swansea, United Kingdom
Belfast Health and Social Care Trust
🇬🇧Belfast, United Kingdom