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).
Study Type
OBSERVATIONAL
Enrollment
46
Optical coherence tomography
CFR will be assessed using transthoracic echocardiography with adenosine infusion.
Satakunta Central Hospital, Pori
Pori, Finland
Turku University Hospital
Turku, Finland
Uncovered stent struts
Percentage of uncovered stent struts per stent by OCT
Time frame: 3 months
Coronary flow reserve
Coronary flow reserve by transthoracic echocardiography.
Time frame: 3 months
MACE and target vessel stent thrombosis
Death, MI (Q wave or non-Q wave), emergent CABG, or justified TLR by repeat PCI or CABG, and target vessel stent thrombosis.
Time frame: 12 months
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