Ischemic Heart DiseaseOCTAVENCT07422688
Optical Coherence Tomography in Acute Vessel Evaluation
A study testing Angiographic Guided PCI and OCT Guided PCI in people with Ischemic Heart Disease and Ischemic Coronary Artery Disease, run by Aarhus University Hospital Skejby at 26 sites in 12 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Ischemic Coronary Artery Disease, ACS (Acute Coronary Syndrome)
- What is being tested?
- Angiographic Guided PCI and OCT Guided PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 26 sitesin 12 countries
- Study dates
- 23 Nov 2025to 1 Sep 2039
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
26 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 12 countries
Denmark5 sites
Aalborg University Hospital
Aalborg, 9100
Aarhus University Hospital Skejby
Aarhus N, 8200
Rigshospitalet
København Ø, 2100
Odense University Hospital
Odense, 5000
Zealand University Hospital, Roskilde Sygehus
Roskilde, 4000
United Kingdom5 sites
Royal Bournemouth Hospital
Bournemouth, BH77DW
St. James's Hospital
Leeds, LS1 3EX
St Bartholomew's Hospital
London, EC1A 7BE
Kings College Hospital
London, SE5 9RS
John Radcliffe Hospital - Oxford Heart Centre
Oxford, OX3 9DU
Sweden4 sites
Sahlgrenska University Hospital
Gothenburg, 41345
Sunderby Sjukhus
Luleå, 97180
Karolinska Universitetssjukhuset
Stockholm, 14157
Akademiske Sjukhuset
Uppsala, 75237
Belgium2 sites
Ziekenhuis Oost-Limburg
Genk, 3600
Leuven University Hospital
Leuven, 3000
Finland2 sites
North Karelia Central Hospital
Joensuu
Kuopio University Hospital
Kuopio, 70210
Norway2 sites
Hospital of Southern Norway, Arendal
Arendal, 4604
Akerhus University Hospital - AHUS
Lørenskog, 1478
About this study
Official title: Optical Coherence Tomography in Acute Vessel Evaluation (OCTAVE)
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
Read the 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.
- Being tested
- Angiographic Guided PCI, OCT Guided PCI
- Keywords
- OCT guided PCI, ACS undergoing PCI
- Medical subject headings
- Myocardial Ischemia, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiographic Guided PCIProcedure or surgery
Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone
OCT Guided PCIProcedure or surgery
Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)
| Study group | Role | What they receive |
|---|---|---|
| Angiographic Guided PCI | Active comparator | Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone Receives: Procedure: Angiographic Guided PCI |
| OCT Guided PCI | Experimental | Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT) Receives: Procedure: OCT Guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined endpoint of major adverse cardiac events (MACE)
Comprising all-cause death, spontaneous myocardial infarction and stroke
Measured: 12 months
Secondary outcomes (17)
Combined endpoint of major adverse cardiac events (MACE)
Comprising all-cause death, spontaneous myocardial infarction and stroke
Measured: 30 days, 36 months and 60 months
Patient-oriented composite (PoCE) MACE endpoint
Comprising all cause death, any myocardial infarction, any unplanned revascularization and stroke
Measured: 30 days, 12 months, 36 months and 60 months
All-cause mortality
All-cause mortality includes death of any cause including cardiac deaths and non-natural causes of deaths
Measured: 30 days, 12 months, 36 months, 60 months and 10 years
Cardiac death
Encompasses death due to coronary heart disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related the cardiac procedure within 28 days from the procedure. If death is not clearly attributable to other non-cardiac causes it is adjudicated as cardiac death.
Measured: 30 days, 12 months, 36 months and 60 months
Spontaneous myocardial infarction
Following 4th universal MI definition
Measured: 30 days, 12 months, 36 months and 60 months
Any ischemia-driven revascularization
Any repeat iscemia-driven revascularization (coronary artery bypass grafting or PCI) except staged revascularization planned during the index procedure
Measured: 30 days, 12 months, 36 months and 60 months
Any unplanned revascularization
Any unplanned repeat revascularization
Measured: 30 days, 12 months, 36 months and 60 months
Ischemia-driven target lesion revascularization
Any non-staged repeat ischemia-driven revascularization (coronary artery bypass grafting or PCI) of any lesion treated at the index admission
Measured: 30 days, 12 months, 36 months and 60 months
Ischemia-driven target vessel revascularization
Any non-staged repeat ischemia-driven revascularization (coronary artery bypass grafting or PCI) of any vessel treated at the index admission
Measured: 30 days, 12 months, 36 months and 60 months
Target lesion revascularization
Any non-staged repeat revascularization (coronary artery bypass grafting or PCI) of any lesion treated at the index admission
Measured: 30 days, 12 months, 36 months and 60 months
Target vessel revascularization
Any non-staged repeat revascularization (coronary artery bypass grafting or PCI) of any vessel treated at the index admission
Measured: 30 days, 12 months, 36 months and 60 months
Stroke
Acute neurological deficit of cerebrovascular cause that persists beyond 24 hours with CT or MRI confirmation
Measured: 30 days, 12 months, 36 months and 60 months
Rose dyspnea Scale
Assesses the severity of dyspnea during specific physical activities, ranging from 0-4. Higher scores indicate worse dyspnea
Measured: 30 days, 12 months, 36 months and 60 months
CCS-angina class
4-level grading system to categorizes stable angina symptoms based on the severity of physical limitations
Measured: 30 days, 12 months, 36 months and 60 months
Peri-procedure related MI
According to the ARC-2 and 4th universal definition criterias
Measured: During or within 48 hours after the procedure (index or staged within the same admission)
Stent thrombosis
Definite, probable or possible in time categories: acute, subacute, late and very late (ARC-2 definitions)
Measured: 30 days, 12 months, 36 months and 60 months
Contrast induced nephropathy
Defined as a >50% increase in plasma creatinine after the procedure within the first 48 hours
Measured: 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start23 Nov 2025
- Primary completion1 Sep 2030 (estimated)
- Study completion1 Sep 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Evald Hoej Christiansen, Aarhus University Hospital Skejby
- Investigators
- Evald H Christiansen, Prof.MD.PhD, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422688
- Sponsor's protocol ID
- OCTAVE_2025
- Acronym
- OCTAVE
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2025
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Limited and pseudo-anonymized data will be transferred to studies investigating the effect of OCT treatment across other studies, so-called meta-analyses. These meta-analyses will be carried out with Rigshospitalet (Copenhagen, Denmark) and the Cardiovascular Research Foundation (New York, USA). Full anonymization means that the information cannot be linked to individuals. The studies to which data are transferred comply with the General Data Protection Regulation and the Danish Data Protection Act. Data from this study will also be transferred to a project at Aarhus University investigating prognosis across patient groups treated with OCT.