Acute Coronary Syndrome Clinical Trial
Official title:
A Randomized Prospective Multicenter Trial to Compare Vascular Healing and Vasodilation at 3 Months After Deployment of PRO-Kinetic Drug-eluting Stent and Endeavor Resolute Zotarolimus-eluting Stent in Patients With Acute Coronary Syndromes by Means of Optical Coherence Tomography and Coronary Flow Reserve
The purpose of this study is to compare vascular healing of the stented segment after deployment of new PRO-Kinetic drug eluting stent and Endeavor Resolute zotarolimus-eluting stent in patients with acute coronary syndromes requiring percutaneous coronary intervention.
Objective: The aim of the trial is to compare vascular healing and vasodilation at 3 months
after deployment of PRO-Kinetic drug-eluting stent and Endeavor Resolute zotarolimus-eluting
stent in patients with acute coronary syndrome.
Design: A prospective, randomized and controlled study comparing coronary flow reserve and
coverage of the PRO-Kinetic DES and Endeavor Resolute DES implanted in acute coronary
syndrome. OCT and CFR measurement at 3 months. Clinical follow up is scheduled at 3, 6 and
12 months.
Primary endpoint: Uncovered stent struts and CFR at 3 months after stent implantation.
Secondary clinical endpoints: MACE and stent thrombosis.
Enrollment: 40 patients (20 receiving PRO-Kinetic DES and 20 receiving Endeavor Resolute
DES).
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Observational Model: Case Control, Time Perspective: Prospective
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