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Enrolling by invitation Not applicable

Optical Coherence Tomography in Acute Vessel Evaluation

NCT07422688 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-11-23
Last updated
2026-10-02

Condition(s) studied

Ischemic Heart DiseaseIschemic Coronary Artery DiseaseACS (Acute Coronary Syndrome)

Investigational drug(s) / intervention(s)

Angiographic Guided PCIOCT Guided PCI

Angiographic Guided PCI: Revascularization by percutaneous coronary intervention (PCI) guided by angiography alone

OCT Guided PCI: Revascularization by percutaneous coronary intervention (PCI) guided by systematic use of intravascular optical coherence tomography (OCT)

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (26)

FacilityCityRegionStatus
Ziekenhuis Oost-Limburg Genk Belgium
Leuven University Hospital Leuven Belgium
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
Kuopio University Hospital Kuopio Finland
Turin Nord Emergency Hospital Turin Italy
Latvia Centre of Cardiology Riga Latvia
Auckland City Hospital Auckland New Zealand
Hospital of Southern Norway, Arendal Arendal Norway
Akerhus University Hospital - AHUS Lørenskog Norway
Hospital Clinic de Barcelona Barcelona Spain
Sahlgrenska University Hospital Gothenburg Sweden
Sunderby Sjukhus Luleå Sweden
Karolinska Universitetssjukhuset Stockholm Sweden
Akademiske Sjukhuset Uppsala Sweden
University Hospital of Zürich Zurich Switzerland
Royal Bournemouth Hospital Bournemouth United Kingdom
St. James's Hospital Leeds United Kingdom
St Bartholomew's Hospital London United Kingdom
Kings College Hospital London United Kingdom
John Radcliffe Hospital - Oxford Heart Centre Oxford United Kingdom

More Aarhus University Hospital Skejby trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07422688 on ClinicalTrials.gov ↗ ← All trials in Italy