XLIMus Drug Eluting Stent: a randomIzed Controlled Trial to Assess Endothelization

The present clinical investigation is designed as a prospective, multicentre, international, randomized, open label, 2-arm parallel group, trial in patients undergoing Percutaneous Coronary Intervention (PCI) comparing Xlimus DES versus Synergy DES with respect to optical coherence tomography (OCT) derived measures at 6-month Follow Up (FU) and clinical events at 12 months after procedure. A total of 180 patients will be recruited and randomized in the two groups in a 2:1 ratio. After index procedure, patients will be followed up by angiographic follow-up at 6 months and clinical follow-up at 12 months.The primary endpoint will be independently evaluated by the Core-Lab which will be blinded as to group assignment

Inclusion criteria

• Age≥18
• Documented coronary artery disease (CAD): stable or unstable angina, Non-ST segment MI.
• PCI considered appropriate and feasible
• Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for implantation with either study stent (no limitation on the number of treated lesions, vessel and lesion length);
• Patient provides written informed consent
• Patient agrees to all required follow-up procedures and visits.
• Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm

Exclusion criteria

• The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, ticlopidine, sirolimus or its derivatives, everolimus or structurally-related compounds, and/or contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled);
• Known hypersensitivity to L605 cobalt chromium, 316L stainless steel, platinum, chromium, iron, nickel or molybdenum;
• Known sensitivity to poly-lactic acid or poly(lactic-co-glycolic acid) polymer;
• Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study and not using adequate contraceptive methods;
• History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
• Previous coronary intervention on target vessel in the 3-months prior to enrollment;
• Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment);
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
• Previously documented left ventricular ejection fraction (LVEF) <30%;
• Evident cardiogenic shock before randomization;
• Patients with left main stem stenosis (>50% by visual estimate);
• In-stent restenosis;
• ST-segment elevation MI;
• Chronic total occlusion/ heavily calcified lesions
• Culprit lesion to a Saphenous Vein graft