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Optical Coherence Tomography in Acute Vessel Evaluation

Enrolling By InvitationNA

Sponsor: Aarhus University Hospital Skejby

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

Interventions: Angiographic Guided PCI, OCT Guided PCI

Countries: Belgium, Denmark, Estonia, Finland, Italy, Latvia, Norway, Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (19)

Genk, Belgium
Leuven, Belgium
Aalborg, Denmark
Aarhus N, Denmark
København Ø, Denmark
Odense, Denmark
Roskilde, Denmark
Tallinn, Estonia
Joensuu, Finland
Turin, Italy
Riga, Latvia
Arendal, Norway
Lørenskog, Norway
Barcelona, Spain
Gothenburg, Sweden
Stockholm, Sweden
Uppsala, Sweden
Zurich, Switzerland
Bournemouth, United Kingdom