The aim of this study is to evaluate the impact of sustained thrombectomy with INDIGO ASPIRATION SYSTEM using CAT RX versus no thrombectomy during primary percutaneous coronary intervention (PPCI) on microvascular obstruction and infarct size, as measured by cardiovascular magnetic resonance (CMR) between 3 and 5 days post PPCI, in patients with anterior STEMI
Age >18 and <75 years old
Acute anterior STEMI with ≥2 mm in two (2) or more contiguous anterior leads or ≥4 mm total ST-segment deviation sum in the anterior leads V1-V4 AND anterior wall motion abnormality noted on a diagnostic quality left ventriculogram or echocardiogram
Culprit lesion proximal or mid LAD at coronary angiography
TIMI thrombus grading > 3 or TIMI flow 0 after guidewire crossing the lesion.
Unable to give Informed consent.
Life expectancy < 1 year.
Contraindication to PCI
STEMI due to stent thrombosis
Parallel
THROMBOASPIRATION WITH INDIGO SYSTEM
Procedure/SurgerySubjects randomized to the treatment arm will be treated with the CAT RX as previously described.
Microvascular obstruction
Incidence of Microvascular obstruction (MVO) assessed by Cardiac Magnetic Resonance
Secondary CMR endpoint:
Left Ventricular Mass in % Left ventricular end-systolic volume (LVESV) Left ventricular end-diastolic volume (LVEDV) Left ventricular end-systolic volume index Left ventricular end-diastolic volume index Ejection fraction (EF)
Secondary exploratory clinical and angiographic endpoint:
Incidence of TIMI 3 flow at the end of primary PCI Post PCI non-hyperemic angio-derived IMR measurements. PCI
Safety endpoint
Incidence of MACE at 1-year follow-up (a composite end point of all-cause death, myocardial infarction, pMCS implant, target lesion revascularization, stent thrombosis, ICD implantation or HF hospitalizations) and each individual component
Safety endpoint
Incidence of device-related SAE(s) and Stroke
Click on the lead sponsor to view all of their trials.
Ceric Sàrl
Lead sponsor
European Cardiovascular Research Center
Collaborator
