Coronary Heart Disease Clinical Trial
Official title:
Randomized Comparison of Biolimus-Eluting and Everolimus-Eluting Stents With Optical Coherence Tomography Guided Stent Implantation in ST Elevation Myocardial Infarction.A 9-Month Angiographic and Optical Coherence Tomography Follow-up.
The primary objective of this study is:
- comparison of a safety and effectiveness of third generation DES (biolimus A9 and
everolimus) in patients with STEMI treated by primary PCI with OCT guidance. A rate of
9 month MACE (deaths, myocardial infarction, ischemia driven TLR) will be assessed in
both groups.
The secondary outcomes are a comparison of (using OCT):
- number of uncovered stent struts
- number of malapposed stents struts
- in-stent neointimal volume
- in-segment assessment of vessel wall response to DES
The aim of this multicenter, prospective, randomized trial with a core lab analysis is to assess the safety and effectiveness (at 9-month follow-up) of third generation DES (biolimus A9 and everolimus) in patients with evolving STEMI with the OCT guidance (to optimize a stent implantation) A serial OCT analysis will be performed to assess the number of either uncovered or malaposed stents strut and a degree of in-stent neointimal hyperplasia. Furthermore, the in-segment vessel wall response to DES implantation will also be analysed. The goal is to enroll 400 patients (200 in each group) with OCT guidance in 100 patients in each group. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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