Acute ST Segment Elevation Myocardial Infarction Clinical Trial
Official title:
Performance of Bioresorbable Scaffold in Primary Percutaneous Intervention of ST Elevation Myocardial Infarct (BVS in STEMI)
Patients presenting with acute ST elevation myocardial infarct urgently need
revascularization. Standard of care is establishing bloodflow through the coronary vessels
using thrombus aspiration catheter, and securing the result by using a metallic drug eluting
stent. New kinds of non-metallic bioresorbable stents are now available. They have however
challenges in structural strength.
The investigators want to compare the new bioresorbable scaffold with traditional metallic
stents in this setting in a prospective, randomized, non-blinded, multicenter study in 120
patients. The investigators will use an imaging technique, optical coherence tomography, to
evaluate the results after 12 months.
The investigators also want to see if modern multislice computed tomography can give useful
information in the follow-up of stented coronary arteries after 12 and 24 months.
Patients presenting with ST elevation myocardial infarction for primary PCI (percutaneous coronary intervention) will be screened. After thrombus aspiration, patient will be asked for oral consent if TIMI flow 2-3. Patient will then be randomized between drug eluting stent (Xience pro, Abbott Vascular Solutions) and bioresorbable scaffold (Absorb, Abbott Vascular Solutions). Optical coherence tomography (OCT) will be performed before stenting and after final result. Stent will be deployed without further predilatation if possible. Follow up at 12 months (clinical, angio with OCT and multislice CT coronary angiogram (MSCT-CA)) and 24 months (MSCT-CA). ;
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