Optical Coherence Tomography in Acute Vessel Evaluation

Enrolling by invitation · Not applicable

Conditions studied: Ischemic Heart Disease, Ischemic Coronary Artery Disease, ACS (Acute Coronary Syndrome)

In brief

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

Key facts

Study ID

NCT07422688

Run by

Aarhus University Hospital Skejby

People needed

3000

Starts

2025-11-23

Expected to finish

2039-09-01

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aalborg University Hospital — Aalborg, Denmark
• Aarhus University Hospital Skejby — Aarhus N, Denmark
• Rigshospitalet — København Ø, Denmark
• Odense University Hospital — Odense, Denmark
• Zealand University Hospital, Roskilde Sygehus — Roskilde, Denmark
• North-Estonia Medical Centre — Tallinn, Estonia
• North Karelia Central Hospital — Joensuu, Finland
• Vivantes Klinikum im Friedrichshain — Berlin, State of Berlin, Germany
• Universitätsklinikum Schleswig-Holstein Campus Kiel — Kiel, Germany
• Turin Nord Emergency Hospital — Turin, Italy
• Latvia Centre of Cardiology — Riga, Latvia
• Radboud University Medicine Center — Nijmegen, Netherlands
• Hospital of Southern Norway, Arendal — Arendal, Norway
• Akerhus University Hospital - AHUS — Lørenskog, Norway
• Hospital Clinic de Barcelona — Barcelona, Spain
• Sahlgrenska University Hospital — Gothenburg, Sweden
• Karolinska Universitetssjukhuset — Stockholm, Sweden
• Akademiske Sjukhuset — Uppsala, Sweden
• University Hospital of Zürich — Zurich, Switzerland
• Royal Bournemouth Hospital — Bournemouth, United Kingdom
• Leuven University Hospital — Leuven, Belgium

Full record on ClinicalTrials.gov

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