Optical Coherence Tomography in Acute Vessel Evaluation (OCTAVE)

Aarhus University Hospital Skejby

Status

Invitation-only

Conditions

Ischemic Coronary Artery Disease

Ischemic Heart Disease

ACS (Acute Coronary Syndrome)

Treatments

Procedure: OCT Guided PCI

Procedure: Angiographic Guided PCI

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07422688

OCTAVE_2025

Details and patient eligibility

About

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

Full 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.

Enrollment

3,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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