A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear) (Onyx ONE Clear)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03647475 |
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Recruitment Status :
Active, not recruiting
First Posted : August 27, 2018
Last Update Posted : July 11, 2019
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Sponsor:
Medtronic Vascular
Information provided by (Responsible Party):
Medtronic Vascular
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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 DAPT treatment receiving reduced duration (1 month) of DAPT following stent implantation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Disease | Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 800 participants |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Prospective, multi-center, single arm study enrolling eligible subjects in the United States and Japan. Subjects will remain in the study with follow-up clinical assessments through 2 years, study exit, or death, whichever comes first. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Onyx ONE Clear: A Single Arm Study With Resolute Onyx in ONE-Month DAPT for High-Bleeding Risk Patients Who Are Considered One-Month Clear (Onyx ONE Clear) |
| Actual Study Start Date : | October 1, 2018 |
| Estimated Primary Completion Date : | July 2020 |
| Estimated Study Completion Date : | October 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent
Subjects who fulfill the inclusion criteria and none of the exclusion criteria will be treated with a Resolute Onyx stent followed by one-month DAPT. The clinical safety of the Resolute Onyx stent as compared to a performance goal will be evaluated using a composite safety endpoint of cardiac death and myocardial infarction at 1 year for a one-month clear population.
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Combination Product: Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT
To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment. |
Primary Outcome Measures :
- Composite endpoint: Cardiac Death and Myocardial Infarction [Time Frame: One year post procedure] [ 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 Outcome Measures :
- Target Lesion Failure [ Time Frame: 2 year post-procedure ]Defined as cardiac death, target vessel myocardial infarction (Q wave and non Q wave), or clinically driven target lesion revascularization(TLR) by percutaneous or surgical method
- Procedure Success [ Time Frame: 2 year post-procedure ]Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.
- Number of Patients with Cardiac Death [ Time Frame: 2 year post-procedure ]All deaths including cardiac death
- Number of Patients with Major Cardiac Event [ Time Frame: 2 year post-procedure ]Major adverse cardiac event (MACE) defined as composite of death, myocardial infarction, or repeat target lesion revascularization (clinically driven) by percutaneous or surgical methods
- Number of Patients with Myocardial Infarction [ Time Frame: 2 year post-procedure ]All myocardial infarction including Target Vessel Myocardial Infarction (TVMI)
- Number of Patients with Target Vessel Failure [ Time Frame: 2 year post-procedure ]Target vessel failure (TVF) defined as composite of cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization (TVR) by percutaneous or surgical methods.
- Number of Patients with Revascularization [ Time Frame: 2 year post-procedure ]All revascularizations (TLR, TVR and non-TVR)
- Number of Patients with Stent Thrombosis [ Time Frame: 2 year post-procedure ]Stent thrombosis (per Academic Research Consortium (ARC) definition)
- Number of Patients with Bleeding [ Time Frame: 2 year post-procedure ]Bleeding per BARC criteria
- Number of Patients with Stroke [ Time Frame: 2 year post-procedure ]Stroke
- Lesion Success [ Time Frame: 2 year post- procedure ]The attainment of <30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method
- Device Success [ Time Frame: 2 year post-procedure ]Attainment of <30% residual stenosis by QCA (or <20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647475
Locations
| United States, New York | |
| Saint Joseph's Hospital Health Center | |
| East Syracuse, New York, United States, 13057 | |
| New York- Presbyterian Hospital/Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, South Carolina | |
| AnMed Health Medical Center | |
| Anderson, South Carolina, United States, 29621 | |
| United States, Texas | |
| Houston Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Medtronic Vascular
Investigators
| Principal Investigator: | David Kandzari, MD | Piedmont Atlanta Hospital, Atlanta, GA | |
| Principal Investigator: | Ajay Kirtane, MD | New York-Presbyterian Hospital/Columbia University Medical Center, New York, NY |
| Responsible Party: | Medtronic Vascular |
| ClinicalTrials.gov Identifier: | NCT03647475 History of Changes |
| Other Study ID Numbers: |
MDT18015RES008 |
| First Posted: | August 27, 2018 Key Record Dates |
| Last Update Posted: | July 11, 2019 |
| Last Verified: | July 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | No |
Additional relevant MeSH terms:
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Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Sirolimus |
Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antineoplastic Agents Antifungal Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |