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

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

The objective of the study is to assess angiographic and clinical performance of Xlimus Drug Eluting Stent (DES) compared to Synergy Bioabsorbable Polymer Everolimus Eluting Stent in patients treated with percutaneous coronary angioplasty

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:

1. Age≥18
2. Documented coronary artery disease (CAD): stable or unstable angina, Non-ST segment MI.
3. PCI considered appropriate and feasible
4. 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);
5. Patient provides written informed consent
6. Patient agrees to all required follow-up procedures and visits.
7. Target lesion suitable for PCI with DES diameter between 2.5 and 4.0 mm

Exclusion Criteria:

1. 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);
2. Known hypersensitivity to L605 cobalt chromium, 316L stainless steel, platinum, chromium, iron, nickel or molybdenum;
3. Known sensitivity to poly-lactic acid or poly(lactic-co-glycolic acid) polymer;
4. 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;
5. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions;
6. Previous coronary intervention on target vessel in the 3-months prior to enrollment;
7. Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment);
8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period;
9. Previously documented left ventricular ejection fraction (LVEF) <30%;
10. Evident cardiogenic shock before randomization;
11. Patients with left main stem stenosis (>50% by visual estimate);
12. In-stent restenosis;
13. ST-segment elevation MI;
14. Chronic total occlusion/ heavily calcified lesions
15. Culprit lesion to a Saphenous Vein graft