Acute ST Segment Elevation Myocardial Infarction Clinical Trial
Official title:
Comparison of the ABSORBTM Everolimus Eluting Bioresorbable Vascular Scaffold System With a Drug- Eluting Metal Stent (XienceTM) in Acute ST-Elevation Myocardial Infarction
This is a Prospective, randomized (1:1), active control, single-blind, non-inferiority,
European multicenter clinical trial.
The primary objective of this study is to assess the neointimal healing score (as evaluated
by intra-coronary OFDI) in patients with ST-elevation Myocardial Infarction (STEMI) and
treated with Abbott Vascular ABSORB everolimus eluting bioresorbable vascular scaffold (BVS)
at 6 months follow-up by comparing with a metallic drug eluting stent (XIENCE). Furthermore,
the safety and feasibility of implanting ABSORB BVS in patients with STEMI is assessed.
It is hypothesized that acutely and at 6 months follow-up implantation of the ABSORB fully
bioresorbable everolimus-eluting scaffold is at least as safe as implantation of metallic
drug-eluting stent, and that at late follow-up the ABSORB scaffold could improve the arterial
healing process and potentially reduce late stent thrombosis in patients presenting with
STEMI.
This is a preparatory trial in anticipation of a major outcome study.
A total of 190 patients will be included in this trial, at 8-10 European sites.
The primary endpoint is arterial healing at 6 month follow up. To assess the arterial
healing, at 6 months follow-up all patients will undergo angiographic follow-up with OFDI
investigation. To score the arterial healing, a Healing Score is used.
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