Status:
COMPLETED
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk Patients
Lead Sponsor:
Medtronic Vascular
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and/or medically unsuitable for more than 1 month...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2020
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT03344653
Start Date
November 2 2017
End Date
October 9 2020
Last Update
December 2 2020
Active Locations (89)
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1
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia, 2065
2
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
3
Bundaberg Cardiology - Friendly Society Private Hospital
Bundaberg, Queensland, Australia, 4670
4
Cairns Hospital
Cairns, Queensland, Australia, 4870