Safety and Efficacy Study Comparing 3 New Types of Coronary Stents

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2010
Background: Retrospective analyses of long-term BASKET findings identified patients with large drug-eluting stents (DES) (\>2.5mm Stents) as patients at risk for late cardiac death/nonfatal myocardial infarction. In view of new DES with absorbable polymers and new bare metal stents BMS) with thin struts and biocompatible polymers, BP-II will be launched to test their comparative clinical safety up to 12 years if treated with an aspirin/prasugrel combination, since prasugrel halved stent thrombosis rates compared to clopidogrel in a large ACS trial. The primary objective is to demonstrate non-inferiority of the Nobori DES stent compared to the Xience Prime DES stent on safety and e cacy in patients requiring stents \>=3.0mm in diameter on the background of contemporary dual antiplatelet therapy (DAPT) with prasugrel and aspirin Set-up: Multicenter open-label randomized trial. Patient inclusion: Unselected series of patients in need of large (\>3mm) stents only in native vessels irrespective of clinical indication. Patient exclusion: In-stent restenosis, Left-main disease, cardiogenic shock, planned surgery \<12months, increased bleeding risk, no compliance expected, History of stroke or transient ischemic attack (TIA). Randomization: By centre using sealed envelopes 1:1:1: Nobori:Xience Prime:Prokinetik-stent.
Epistemonikos ID: fa13f4bd6b553d26ccd7b24e656557eaecdcf9b1
First added on: May 05, 2024