NCT03647475CompletedNot Applicable
Onyx ONE Clear: A Single Arm Trial With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear)
Medtronic Vascular7 sites in 1 country752 target enrollmentStarted: October 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 752
- Locations
- 7
- Primary Endpoint
- Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction
Study Overview
Brief Summary
The purpose of this trial 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To qualify as high-bleeding risk and/or a candidate for 1-month DAPT, subject had to meet at least one of the criteria detailed below:
- •Adjunctive chronic oral anticoagulation treatment planned to continue after PCI
- •Age ≥ 75 years old
- •Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to procedure)
- •Any prior documented intracerebral bleed
- •Any documented stroke in the last 12 months
- •Hospital admission for bleeding during the prior 12 months
- •Active non-skin cancer currently undergoing treatment or surveillance (in lieu of treatment)
- •Planned daily NSAID (other than aspirin) or steroids for ≥30 days after PCI
- •Planned surgery that would require interruption of DAPT (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
- •Expected non-compliance for at least 6 months DAPT for other medical reasons
Exclusion Criteria
- •Pregnant and breastfeeding women
- •Subjects requiring a planned PCI procedure after 1 month of index procedure
- •Procedure planned to require non-trial stents, stand-alone POBA, or stand-alone atherectomy
- •Active bleeding at the time of inclusion
- •Cardiogenic shock
- •Subject with planned surgery or procedure necessitating discontinuation of DAPT within one month following index procedure
- •Subject not expected to comply with long-term single antiplatelet therapy
- •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
Outcomes
Primary Outcomes
Composite Endpoint: Number of Participants With Cardiac Death and Myocardial Infarction
Time Frame: One Month to one year
Composite of cardiac death and myocardial infarction at one year for a one-month clear population \[Time Frame: One month to one year\]
Secondary Outcomes
- Number of Patients With Myocardial Infarction(One Month to One Year)
- Lesion Success(End of Procedure, an average of 42 minutes)
- All Participants Deaths Including Cardiac Death(One Month to One Year)
- Number of Patients With Major Cardiac Event(One Month to One Year)
- Number of Patients With Target Vessel Failure(One Month to One Year)
- Number of Patients With Revascularization(One Month to One Year)
- Number of Patients With Stent Thrombosis(One Month to One Year)
- Number of Patients With Bleeding(One Month to One Year)
- Number of Patients With Stroke(One Month to One Year)
- Number of Participants With Target Lesion Failure(One Month to One Year)
- Number of Participants With Procedure Success(Procedure to hospital discharge, an average of 1.3 days)
- Device Success(End of Procedure an average of 42 minutes)
Investigators
Study Sites (7)
Loading locations...
Similar Trials
Completed
Not Applicable
A Randomized Controlled Trial With Resolute Onyx in One Month Dual Antiplatelet Therapy (DAPT) for High-Bleeding Risk PatientsCoronary Artery DiseaseNCT03344653Medtronic Vascular2,000
Active, not recruiting
Not Applicable
RESOLUTE ONYX China Single Arm StudyIschemic Heart DiseaseStenotic Coronary LesionCardiovascular DiseasesCoronary Artery DiseaseArteriosclerosisNCT03471845Medtronic Vascular591
Completed
Not Applicable
Onyx ONE Clear Study: A Single Arm Study with Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients who are considered One-Month ClearIschemic heart diseaseJPRN-UMIN000034936Medtronic Japan Co., Ltd800
Completed
Not Applicable
Onyx ONE Study; A Randomized Controlled Trial with Resolute Onyx in One Month DAPT for High-Bleeding Risk Patientsangina pectorisNL-OMON50309Medtronic B.V.300
Completed
Not Applicable
Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical StudyCoronary Artery DiseaseNCT02419521Medtronic Vascular75