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

Medtronic

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Biosensors BioFreedom BA9 Drug Coated Coronary Stent; Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03344653

MDT17054RES007

Details and patient eligibility

About

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 DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.

Enrollment: 2,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

Resolute Onyx stent

Active Comparator group

Description:

Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be randomly allocated in a 1:1 fashion to treatment with a Resolute Onyx stent or the BioFreedom stent followed by 1-month DAPT. Subjects implanted with the Resolute Onyx stent will be assessed for non-inferiority compared to those implanted with the BioFreedom stent using a composite safety endpoint of cardiac death, myocardial infarction, and definite/probable stent thrombosis, at 1 year post-procedure.

Treatment:

Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System

BioFreedom stent

Active Comparator group

Description:

Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be randomly allocated in a 1:1 fashion to treatment with a Resolute Onyx stent or the BioFreedom stent followed by 1-month DAPT. Subjects implanted with the Resolute Onyx stent will be assessed for non-inferiority compared to those implanted with the BioFreedom stent using a composite safety endpoint of cardiac death, myocardial infarction, and definite/probable stent thrombosis, at 1 year post-procedure.

Treatment:

Device: Biosensors BioFreedom BA9 Drug Coated Coronary Stent