Optical Coherence Tomography in Acute Vessel Evaluation (OCTAVE)

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Ischemic Heart Disease; Ischemic Coronary Artery Disease; ACS (Acute Coronary Syndrome)
• Intervention / Treatment: Procedure: Angiographic Guided PCI; Procedure: OCT Guided PCI

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.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Leuven University Hospital
• Denmark
  • Aalborg, Denmark, 9100
    • Aalborg University Hospital
  • Aarhus N, Denmark, 8200
    • Aarhus University Hospital Skejby
  • København Ø, Denmark, 2100
    • Rigshospitalet
  • Odense, Denmark, 5000
    • Odense University Hospital
  • Roskilde, Denmark, 4000
    • Zealand University Hospital, Roskilde Sygehus
• Estonia
  • Tallinn, Estonia, 13419
    • North-Estonia Medical Centre
• Finland
  • Joensuu, Finland
    • North Karelia Central Hospital
• Germany
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein Campus Kiel
  • State of Berlin
    • Berlin, State of Berlin, Germany, 10249
      • Vivantes Klinikum im Friedrichshain
• Italy
  • Turin, Italy, 10154
    • Turin Nord Emergency Hospital
• Latvia
  • Riga, Latvia, LV-1002
    • Latvia Centre of Cardiology
• Netherlands
  • Nijmegen, Netherlands
    • Radboud University Medicine Center
• Norway
  • Arendal, Norway, 4604
    • Hospital of Southern Norway, Arendal
  • Lørenskog, Norway, 1478
    • Akerhus University Hospital - AHUS
• Sweden
  • Gothenburg, Sweden, 41345
    • Sahlgrenska University Hospital
  • Stockholm, Sweden, 14157
    • Karolinska Universitetssjukhuset
• Switzerland
  • Zurich, Switzerland, 8091
    • University Hospital of Zurich
• United Kingdom
  • Bournemouth, United Kingdom, BH77DW
    • Royal Bournemouth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Angiographic Guided PCI; Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone	Procedure: Angiographic Guided PCI; Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone
Experimental: OCT Guided PCI; Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)	Procedure: OCT Guided PCI; Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined endpoint of major adverse cardiac events (MACE)	Comprising all-cause death, spontaneous myocardial infarction and stroke	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined endpoint of major adverse cardiac events (MACE)	Comprising all-cause death, spontaneous myocardial infarction and stroke	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	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	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.	30 days, 12 months, 36 months and 60 months
Spontaneous myocardial infarction	Following 4th universal MI definition	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	30 days, 12 months, 36 months and 60 months
Any unplanned revascularization	Any unplanned repeat revascularization	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	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	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	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	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	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	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	30 days, 12 months, 36 months and 60 months
Peri-procedure related MI	According to the ARC-2 and 4th universal definition criterias	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)	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	48h

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast volume	Total volume of contrast used at index admission	Baseline (index procedure and procedures staged within the same index admission)
Fluoroscopy time	Total fluoroscopy time during index admission	Baseline (index procedure and procedures staged within the same index admission)
Length of stents implanted in culprit lesion	Total length of stents implanted in culprit lesion	Baseline (index procedure and procedures staged within the same index admission)
Number of NCL treated	Number of Non Culprit Lesions treated	Baseline (index procedure and procedures staged within the same index admission)
Procedural failure	No stent implanted in target lesion	Baseline (index procedure and procedures staged within the same index admission)
Procedural success	TIMI III flow and less than 30% diameter stenosis in target segments by corelab QCA	Baseline (index procedure and procedures staged within the same index admission)
Procedure time	Total procedure time at index admission	Baseline (index procedure and procedures staged within the same index admission)

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Collaborators: Abbott
• Investigators: Study Chair: Evald H Christiansen, Prof.MD.PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2025
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2039

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: OCT guided PCI; ACS undergoing PCI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: OCTAVE_2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No