Optical Coherence Tomography in Acute Vessel Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Angiographic Guided PCI, OCT Guided PCI.
- Who it may be relevant to
- Registry conditions: Ischemic Heart Disease, Ischemic Coronary Artery Disease, ACS (Acute Coronary Syndrome). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Denmark, Estonia, Finland, Germany +8
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Optical Coherence Tomography in Acute Vessel Evaluation (OCTAVE)
Overview
The purpose is to investigate if a strategy of routine OCT based diagnosis and guidance of PCI improves clinical outcomes compared with a standard strategy of guidance by angiography in patients presenting with ACS
Detailed description
Patients presenting with acute coronary syndrome (ACS) have worse short and mid-term prognosis compared with patients revascularized for chronic coronary syndrome. Angiographic assessment of patients with ACS is frequently limited by high ambiguity both in identification of culprit lesions, characterization of non-culprit lesions, and in identification of suboptimal treatment results. Intravascular imaging may improve diagnosis and allow for better treatment optimization during coronary intervention of patients with ACS. The large-scale Chinese IVUS-ACS trial showed a 50% reduction in one-year MACE with IVUS-guided PCI in patients with ACS whereas a number of small studies on routine OCT guiding as well as ACS subgroups in RCTs did not indicate a potential similar benefit with OCT. OCT assessment has several theoretical advantages over IVUS in patients with ACS indicating the need for a well-designed strategy trial on OCT vs angiographic guided PCI.
Hypothesis: Routine OCT-guided diagnosis and revascularization yields superior one-year clinical outcome compared with standard angiography-guided diagnosis and revascularization in patients with acute coronary syndrome Methods: Investigator initiated, open label, prospective, 1:1 randomized, multi-center, clinical outcome, superiority trial.
Primary Endpoint: Major adverse cardiac events (MACE) comprising all-cause death, spontaneous myocardial infarction and stroke.
Interventions
- Procedure Angiographic Guided PCI
Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone - Procedure OCT Guided PCI
Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
Primary outcome measures
- Combined endpoint of major adverse cardiac events (MACE) [Time frame: 12 months]
Secondary outcome measures (12)
- Combined endpoint of major adverse cardiac events (MACE) [Time frame: 30 days, 36 months and 60 months]
- Patient-oriented composite (PoCE) MACE endpoint [Time frame: 30 days, 12 months, 36 months and 60 months]
- All-cause mortality [Time frame: 30 days, 12 months, 36 months, 60 months and 10 years]
- Cardiac death [Time frame: 30 days, 12 months, 36 months and 60 months]
- Spontaneous myocardial infarction [Time frame: 30 days, 12 months, 36 months and 60 months]
- Any ischemia-driven revascularization [Time frame: 30 days, 12 months, 36 months and 60 months]
- Any unplanned revascularization [Time frame: 30 days, 12 months, 36 months and 60 months]
- Ischemia-driven target lesion revascularization [Time frame: 30 days, 12 months, 36 months and 60 months]
- Ischemia-driven target vessel revascularization [Time frame: 30 days, 12 months, 36 months and 60 months]
- Target lesion revascularization [Time frame: 30 days, 12 months, 36 months and 60 months]
- Target vessel revascularization [Time frame: 30 days, 12 months, 36 months and 60 months]
- Stroke [Time frame: 30 days, 12 months, 36 months and 60 months]
Eligibility criteria
Inclusion criteria
Clinical inclusion criteria:
- NSTEMI, STEMI
- Symptom duration <12h for STEMI and <48h for NSTEMI
- Age ≥ 18yrs
- Ability to provide written informed consent
Angiographic inclusion criteria:
- Angiographic signs of at least one possible culprit lesion. Signs including acute occlusion, partial occlusion, proximal embolus, haziness, high grade stenosis, stent thrombosis
- Wire in true distal lumen
Exclusion criteria
Clinical exclusion criteria
- Intravascular imaging evaluation of any lesions at index procedure
- Cardiogenic shock
- Sustained ventricular tachycardia or ventricular fibrillation
- Planned CABG
- Life expectancy <1 year
- Known severe heart failure with NYHA class equal or above III
- Known ejection fraction <30% before the admission
- Known renal failure with GFR <30 ml/min/1.73 m2
- Active bleeding or coagulopathy
- Relevant allergies (contrast media, aspirin, clopidogrel, ticagrelor, everolimus)
- Suspected inability to lie flat for the duration of the PCI procedure
- Inability to comply with the planned follow-up program
- Known or anticipated compliance problems with medical therapy
Angiographic exclusion criteria
- Study lesion involving the Left main coronary artery
- Study lesion involving a true bifurcation lesion with a SB >2.5mm
- Severe tortuosity
- Distal embolus
- Isolated coronary artery spasm
- Suspected spontaneous coronary artery dissection
- Chronic total occlusions with treatment indication and no antegrade intra plaque wire pass
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 5 centers
- Aalborg University Hospital — Aalborg
- Aarhus University Hospital Skejby — Aarhus N
- Rigshospitalet — København Ø
- Odense University Hospital — Odense
- Zealand University Hospital, Roskilde Sygehus — Roskilde
Sweden · 3 centers
- Sahlgrenska University Hospital — Gothenburg
- Karolinska Universitetssjukhuset — Stockholm
- Akademiske Sjukhuset — Uppsala
Germany · 2 centers
- Vivantes Klinikum im Friedrichshain — Berlin
- Universitätsklinikum Schleswig-Holstein Campus Kiel — Kiel
Norway · 2 centers
- Hospital of Southern Norway, Arendal — Arendal
- Akerhus University Hospital - AHUS — Lørenskog
Belgium · 1 center
- Leuven University Hospital — Leuven
Estonia · 1 center
- North-Estonia Medical Centre — Tallinn
Finland · 1 center
- North Karelia Central Hospital — Joensuu
Italy · 1 center
- Turin Nord Emergency Hospital — Turin
Latvia · 1 center
- Latvia Centre of Cardiology — Riga
Netherlands · 1 center
- Radboud University Medicine Center — Nijmegen
Spain · 1 center
- Hospital Clinic de Barcelona — Barcelona
Switzerland · 1 center
- University Hospital of Zürich — Zurich
United Kingdom · 1 center
- Royal Bournemouth Hospital — Bournemouth
Identifiers
NCT: NCT07422688 · OCTAVE_2025