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

N/AActive Not RecruitingNCT03171311

Aarhus University Hospital Skejby1,201 enrolled

Overview

The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,201

Conditions

Ischaemic Heart Disease Ischemic Heart Disease

Interventions

Angiographic guided PCIPROCEDURE

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

OCT guided PCIPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (38)

Outcomes

Primary Outcomes

Combined endpoint of major adverse cardiac events (MACE)

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

Time frame: 24 months

Secondary Outcomes

Study bifurcation oriented composite endpoint

Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

Time frame: 1 month

Study bifurcation oriented composite endpoint

Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

Time frame: 12 months

Study bifurcation oriented composite endpoint

Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

Time frame: 24 months

Study bifurcation oriented composite endpoint

Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

Time frame: 36 months

Study bifurcation oriented composite endpoint

Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

Time frame: 48 months

Study bifurcation oriented composite endpoint

Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation

Time frame: 60 months

Data from ClinicalTrials.gov

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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

...and 28 more locations

Patient oriented composite endpoint

Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke

Patient oriented composite endpoint

Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke

Time frame: 12 months

Patient oriented composite endpoint

Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke

Time frame: 24 months

Patient oriented composite endpoint

Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke

Time frame: 36 months

Patient oriented composite endpoint

Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke

Time frame: 48 months

Patient oriented composite endpoint

Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke

Time frame: 60 months

All-cause mortality