Using light-based imaging to make heart stent treatment safer and more effective
| ISRCTN | ISRCTN10469053 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10469053 |
| Secondary identifying numbers | 2502300 |
- Submission date
- 30/10/2025
- Registration date
- 03/11/2025
- Last edited
- 03/11/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
When someone has a heart attack or other serious heart problem (called acute coronary syndrome or ACS), they tend to have worse outcomes than people treated for more stable heart conditions. Doctors usually use X-ray images (angiography) to guide treatment, but these images can sometimes be unclear. A newer technique called OCT (optical coherence tomography) gives much more detailed pictures from inside the blood vessels and may help doctors treat patients more effectively. This study aims to find out whether using OCT to guide treatment leads to better outcomes than using standard angiography in people with ACS.
Who can participate?
Adults aged 18 or older who come to hospital with a heart attack (either STEMI or NSTEMI) and whose symptoms started recently (within 12 hours for STEMI or 48 hours for NSTEMI) may be eligible. People who are very unwell (such as those in shock or with serious kidney problems) or unable to give consent cannot take part.
What does the study involve?
Participants will be randomly assigned to one of two groups. Both groups will receive standard care for their heart condition, including treatment of the blocked artery. One group will have their treatment guided by OCT imaging, while the other group will be treated using standard angiography. Doctors may also assess other arteries during the hospital stay. All participants will be followed up for one year to see how they are doing.
What are the possible benefits and risks of participating?
Taking part may help doctors better understand how to treat heart attacks more effectively. OCT imaging may offer more precise treatment, but it is not yet proven to be better. Risks are similar to those of standard heart procedures, including bleeding, allergic reactions, or complications from the procedure itself.
Where is the study run from?
Aarhus University Hospital in Denmark
When is the study starting and how long is it expected to run for?
September 2025 to November 2037.
Who is funding the study?
Abbott (Denmark)
Who is the main contact?
Prof Evald Hoej Christiansen, evald.christiansen@rm.dk
Dr Emil Holck Nielsen, eh@clin.au.dk
Helle Bargsteen, hellbarg@rm.dk
Contact information
Prof Evald Hoej Christiansen
Principal investigator
Principal investigator
Palle Juul-Jensens Blvd. 99
Aarhus N
8200
Denmark
 ORCID ID |
0000-0002-8740-4862 |
|---|---|
| Phone | +45 78450000 |
| evald.christiansen@rm.dk |
Dr Emil Holck Nielsen
Scientific
Scientific
Palle Juul-Jensens Blvd. 99
Aarhus N
8200
Denmark
| Phone | +45 31419472 |
|---|---|
| eh@clin.au.dk |
Mrs Helle Bargsteen
Public, Scientific
Public, Scientific
Palle Juul-Jensens Blvd. 99
8200
8200
Denmark
| Phone | +45 26797083 |
|---|---|
| hellbarg@rm.dk |
Study information
| Study design | Open label prospective randomized multi-center clinical outcome superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Optical coherence tomography in acute vessel evaluation |
| Study acronym | OCTAVE |
| Study objectives | Routine OCT-guided PCI yields superior one-year clinical outcome compared with standard angiographic guided PCI. |
| Ethics approval(s) |
Approved 29/09/2025, The Medicinal Research Ethics Committees (MREC) Denmark (Ørestads Boulevard 5, Bygning 37K, st., København S, 2300, Denmark; +45 72 21 66 77; kontakt@dvmk.dk), ref: 2502300 |
| Health condition(s) or problem(s) studied | Optimizing percutaneous coronary intervention (PCI) for patients with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) |
| Intervention | OCT guided group: OCT is a light-based intracoronary imaging technique that provides high-resolution cross-sectional images from inside the coronary arteries. It enables detailed assessment of plaque characteristics, vessel and stent dimensions. OCT is pre-defined to be performed before (pre-PCI) and after (post-PCI). If the culprit lesion cannot be clearly identified on initial angiography, OCT will be used to determine the culprit lesion. For non-culprit lesions, OCT is used to guides the decision for stenting according to predefined criteria (Distal external elastic lamina (EEL) reference diameter > 2.75 mm, and one of the following: 1) Significant thrombus or plaque rupture, 2) Minimum lumen area (MLA) < 2.0 mm² (or < 3.1 mm² in proximal LAD), 3) Lumen area stenosis > 75% or 4) MLA < 4.0 mm² with either thin-cap fibroatheroma (TCFA), thrombus, or lipid arc ≥ 90°). Angiographic guided group: Control treatment follows current best clinical practice. OCT is not permitted. Intravascular ultrasound (IVUS) may only be used as a bailout option to resolve a critical procedural issue when no other diagnostic method is available or adequate. Centers using physiological measurements to guide treatment of non-culprit lesions may continue to do so according to local standard practice. Follow-up: Follow-up is performed at 30 days, and at 1, 2, 3, and 5 years after the procedure. Each annual follow-up visit may occur within a ±6-week window around the target date and is conducted via telephone contact or outpatient visit. Unscheduled follow-up is performed if a patient experiences or is suspected to have a SAE (serious adverse event). At 10 years, follow-up is done either registry-based or by phone call to assess death from any cause. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | OCT-guided PCI vs angiographic guided-PCI. |
| Primary outcome measure | Combined endpoint of major adverse cardiac events (MACE). Comprising all-cause death, spontaneous myocardial infarction and stroke at 12 months |
| Secondary outcome measures | 1. Major adverse cardiac events (MACE) are measured using clinical event adjudication of all-cause death, spontaneous myocardial infarction and stroke at 30 days, 36 months and 60 months 2. Patient-oriented composite endpoint (PoCE MACE) is measured using clinical event adjudication of all-cause death, any myocardial infarction, any unplanned revascularization and stroke at 30 days, 12 months, 36 months and 60 months 3. All-cause mortality is measured using clinical event adjudication and vital status records at 30 days, 12 months, 36 months, 60 months and 10 years 4. Cardiac death is measured using clinical event adjudication based on death certificates, hospital records and investigator reports at 30 days, 12 months, 36 months and 60 months 5. Spontaneous myocardial infarction is measured using the 4th Universal Definition of MI criteria applied to clinical records and biomarker data at 30 days, 12 months, 36 months and 60 months 6. Any ischemia-driven revascularization is measured using clinical event adjudication of coronary artery bypass grafting or PCI procedures excluding staged procedures at 30 days, 12 months, 36 months and 60 months 7. Any unplanned revascularization is measured using clinical event adjudication of repeat revascularization procedures not planned during the index procedure at 30 days, 12 months, 36 months and 60 months 8. Ischemia-driven target lesion revascularization is measured using clinical event adjudication of non-staged repeat PCI or CABG of lesions treated at index admission at 30 days, 12 months, 36 months and 60 months 9. Ischemia-driven target vessel revascularization is measured using clinical event adjudication of non-staged repeat PCI or CABG of vessels treated at index admission at 30 days, 12 months, 36 months and 60 months 10. Target lesion revascularization is measured using clinical event adjudication of non-staged repeat PCI or CABG of lesions treated at index admission at 30 days, 12 months, 36 months and 60 months 11. Target vessel revascularization is measured using clinical event adjudication of non-staged repeat PCI or CABG of vessels treated at index admission at 30 days, 12 months, 36 months and 60 months 12. Stroke is measured using clinical event adjudication based on neurological assessment and CT or MRI confirmation at 30 days, 12 months, 36 months and 60 months 13. Dyspnea severity is measured using the Rose Dyspnea Scale questionnaire at 30 days, 12 months, 36 months and 60 months 14. Angina severity is measured using the Canadian Cardiovascular Society (CCS) angina classification at 30 days, 12 months, 36 months and 60 months Time-specific secondary endpoints: 15. Peri-procedural myocardial infarction is measured using ARC-2 and 4th Universal Definition criteria applied to biomarker and ECG data during or within 48 hours after the procedure 16. Stent thrombosis is measured using ARC-2 definitions of definite, probable or possible thrombosis at 30 days, 12 months, 36 months and 60 months 17. Contrast-induced nephropathy is measured using plasma creatinine levels with a >50% increase from baseline within 48 hours after the procedure Procedural endpoints: 18. Contrast volume is measured using procedural records at baseline (index procedure and procedures staged within the same index admission) 19. Procedure time is measured using procedural records at baseline (index procedure and procedures staged within the same index admission) 20. Fluoroscopy time is measured using procedural records at baseline (index procedure and procedures staged within the same index admission) 21. Length of stents implanted in culprit lesion is measured using procedural records at baseline (index procedure and procedures staged within the same index admission) 22. Number of non-culprit lesions treated is measured using procedural records at baseline (index procedure and procedures staged within the same index admission) 23. Procedural failure is measured using procedural records indicating no stent implantation in target lesion at baseline (index procedure and procedures staged within the same index admission) Angiographic endpoint: 24. Procedural success is measured using corelab quantitative coronary angiography (QCA) showing TIMI III flow and <30% diameter stenosis in target segments at baseline (index procedure and procedures staged within the same index admission) |
| Overall study start date | 01/09/2025 |
| Completion date | 01/11/2037 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | 3000 |
| Key inclusion criteria | Clinical: 1. NSTEMI, STEMI 2. Symptom duration < 12h for STEMI and <48h for NSTEMI - 3. Age ≥ 18yrs 4. Ability to provide written informed consent Angiographic: 1. Angiographic signs of at least one possible culprit lesion. Signs including acute occlusion, partial occlusion, proximal embolus, haziness, high grade stenosis, stent thrombosis 2. Wire in true distal lumen |
| Key exclusion criteria | Clinical: 1. Intravascular imaging evaluation of any lesions at index procedure 2. Cardiogenic shock 3. Sustained ventricular tachycardia or ventricular fibrillation 4. Planned CABG 5. Life expectancy < 1 year 6. Known severe heart failure with NYHA class ≥ III 7. Known ejection fraction < 30% before the admission 8. Known renal failure with GFR < 30 ml/min/1.73 m² 9. Active bleeding or coagulopathy 10. Relevant allergies (contrast media, aspirin, clopidogrel, ticagrelor, everolimus) 11. Suspected inability to lie flat for the duration of the PCI procedure 12. Inability to comply with the planned follow-up program 13. Known or anticipated compliance problems with medical therapy Angiographic: 1. Study lesion involving the Left main coronary artery 2. Study lesion involving a true bifurcation lesion with a side branch > 2.5 mm 3. Severe tortuosity 4. Distal embolus 5. Isolated coronary artery spasm 6. Suspected spontaneous coronary artery dissection 7. Chronic total occlusions with treatment indication and no antegrade intra-plaque wire pass |
| Date of first enrolment | 10/11/2025 |
| Date of final enrolment | 01/11/2027 |
Locations
Countries of recruitment
- Austria
- Belgium
- Denmark
- England
- Estonia
- Finland
- Germany
- Ireland
- Italy
- Latvia
- Netherlands
- Norway
- Poland
- Sweden
- Switzerland
- United Kingdom
Study participating centres
Leuven University Hospital
Leuven
3000
Belgium
3000
Belgium
Aalborg University Hospital
Aalborg
9100
Denmark
9100
Denmark
Aarhus University Hospital Skejby
Aarhus N
8200
Denmark
8200
Denmark
Odense University Hospital
Odense
5000
Denmark
5000
Denmark
Rigshospitalet
København Ø
2100
Denmark
2100
Denmark
Zealand University Hospital
Roskilde
4000
Denmark
4000
Denmark
North-Estonia Medical Centre
Tallinn
13419
Estonia
13419
Estonia
North Karelia Central Hospital
Joensuu
80210
Finland
80210
Finland
Vivantes Klinikum im Friedrichshain
Berlin
10249
Germany
10249
Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel
24105
Germany
24105
Germany
Gemelli General Hospital, Catholic University of the Sacred Heart
Rome
00168
Italy
00168
Italy
Latvia Centre of Cardiology
Riga
1002
Latvia
1002
Latvia
Radboud University Medicine Center
Nijmegen
6525
Netherlands
6525
Netherlands
Hospital of Southern Norway
Arendal
4604
Norway
4604
Norway
Haukeland University Hospital
Bergen
5009
Norway
5009
Norway
Sahlgrenska University Hospital
Blå stråket 5
Göteborg
413 45
Sweden
Göteborg
413 45
Sweden
University Hospital Basel
Universitätsspital CH, Petersgraben 4
Basel
4031
Switzerland
Basel
4031
Switzerland
Bournmouth
Royal Bournemouth Hospital
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
Castle Lane East
Bournemouth
BH7 7DW
United Kingdom
Sponsor information
Aarhus University Hospital
Hospital/treatment centre
Hospital/treatment centre
Palle Juul-Jensens Blvd. 99
Aarhus N
8200
Denmark
| Phone | +45 78450000 |
|---|---|
| Hjertesygdomme@auh.rm.dk | |
| Website | http://www.en.auh.dk/ |
"ROR" |
https://ror.org/040r8fr65 |
Funders
Funder type
Industry
Abbott Laboratories
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Abbott, Abbott U.S., Abbott Alkaloidal Company
- Location
- United States of America
Results and Publications
| Intention to publish date | 15/05/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Positive, neutral as well as negative or inconclusive, will be published in an international cardiovascular journal. The funding company have no influence on study design, study conduct, analysis, interpretation and reporting of derived results. |
| IPD sharing plan | 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. |
Editorial Notes
30/10/2025: Trial's existence confirmed by The Medicinal Research Ethics Committees (MREC) Denmark.
