A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients

Launched by MEDTRONIC VASCULAR · Nov 13, 2017

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 75 years old
• • Any prior documented intracerebral bleed
• • Any documented stroke in the last 12 months
• • Hospital admission for bleeding during the prior 12 months
• • Non-skin cancer diagnosed or treated ≤3 years
• • Planned surgery within the next 12 months
• • Renal failure defined as: Creatinine clearance \<40 ml/min
• • Thrombocytopenia (PLT \<100,000/mm3)
• • Severe chronic liver disease defined as: subjects who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
• Exclusion Criteria:
• • Pregnant and breastfeeding women
• • Subjects requiring a planned PCI procedure after 1 month of index procedure
• • Active bleeding at the time of inclusion
• • Cardiogenic shock
• • A known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (eg, BioLinx™), stainless steel (or other metal ions found in 316L stainless steel), zinc, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
• • PCI during the previous 6 months for a lesion other than the target lesion of the index procedure
• • Participation in another clinical study within 12 months after index procedure
• • Subjects with life expectancy of less than 2 years