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 (25)
Facility
City
Region
Status
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
More Aarhus University Hospital Skejby trials in Denmark
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.
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