Everolimus-Eluting Coronary Artery Stent - Vietnam Registration 2402767ĐKLH/BYT-HTTB

The Everolimus-coated XIENCE Skypoint™ coronary stent system is indicated to improve the lumen diameter of the coronary arteries in the following cases: • Patients with symptomatic coronary artery disease due to de novo, separate, original coronary artery lesions. • To restore coronary blood flow in patients with acute myocardial infarction, occurring within 12 hours of the onset of symptoms. • To treat patients who are concurrently diagnosed with diabetes, acute coronary syndrome, double vessel disease (two different lesions in the two different coronary arteries), lesions in the smaller coronary arteries; lesions where the treatment will result in the retention of the side branches (lesions of the side branches with a diameter of 2 mm or more and/or a stenosis <50%); to treat elderly patients (≥65 years of age), and to treat both men and women. • Treatment of patients at high risk of bleeding (high bleeding risk, HBR) undergoing dual anti-platelet therapy (DAPT) for a minimum duration of 28 days. • To treat patients with in-stent restenosis in the coronary arteries; chronic total occlusion of the coronary arteries (determined as a coronary artery lesion with a TIMI flow of 0 and lasting more than 3 months); bifurcation coronary artery lesions and left main coronary artery lesions. In all cases, the length of the lesion to be treated must be shorter than the nominal length of the stent (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, 28 mm, 33 mm, or 38 mm) with a reference vessel diameter ≥2.00 mm and ≤5.25 mm.