Medtronic Announces Onset of Onyx ONE Clear study in High Bleeding Risk Patients with Resolute Onyx DES
Shots:
- Onyx ONE Clear study will assess one-month DAPT in high bleeding risk patients implanted with the Resolute Onyx DES in the US and Japan evaluating its safety i.e. risk of cardiac death- heart attack and stent thrombosis
- Onyx ONE Clear is similar to Onyx ONE Global Study- involving administration of (aspirin + an anti-clotting medication) followed by PCI with Resolute Onyx DES- combine to form Onyx ONE Month DAPT Program (N=~2700) with 140 sites WW
- This study will assist in understanding insights of patients at high risk of bleeding- and with unexpected bleeding occurrence also help in meeting the unmet needs of patients
- With more than 20-000 patients have undergone DAPT duration trials. Resolute Onyx DES received CE Mark in Sept- 2014 with FDA approval in April -2017
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