Using light-based imaging to make heart stent treatment safer and more effective

Optical coherence tomography in acute vessel evaluation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10469053

Enrollment

3000

Registered

2025-11-03

Start date

2025-11-10

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Optimizing percutaneous coronary intervention (PCI) for patients with ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) Circulatory System

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to 105 Years

Inclusion criteria

Inclusion criteria: Current key inclusion criteria as of 16/12/2025: Clinical: 1. NSTEMI, STEMI 2. Symptom duration < 12h for STEMI and <72h 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 _____ Previous 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

Exclusion criteria

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 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

Design outcomes

Primary

Measure	Time frame
Combined endpoint of major adverse cardiac events (MACE). Comprising all-cause death, spontaneous myocardial infarction and stroke at 12 months	—

Secondary

Measure	Time frame
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 m	—

Measure

Time frame

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 m

—

Countries

Austria, Belgium, Denmark, England, Estonia, Finland, Germany, Ireland, Italy, Latvia, Netherlands, Norway, Poland, Sweden, Switzerland, United Kingdom

Contacts

Public ContactHelle Bargsteen

hellbarg@rm.dk+45 26797083

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026