RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)
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| ClinicalTrials.gov Identifier: NCT03584464 |
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Recruitment Status :
Active, not recruiting
First Posted : July 12, 2018
Results First Posted : January 12, 2022
Last Update Posted : October 12, 2022
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To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Disease | Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 205 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System |
| Actual Study Start Date : | May 14, 2018 |
| Actual Primary Completion Date : | November 4, 2020 |
| Estimated Study Completion Date : | January 2023 |
| Arm | Intervention/treatment |
|---|---|
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Bifurcation Cohort
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
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Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm |
- Number of Participants With Target Vessel Failure (TVF) [ Time Frame: 12 Months ]Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
- Number of Participants With Cardiac Death [ Time Frame: 12 months ]Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.
- Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI) [ Time Frame: Up to 12 months ]Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)
- Number of Participants With Target Lesion Revascularization (TLR) [ Time Frame: 12 months ]Target Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization.
- Number of Participants With Target Vessel Revascularization (TVR) [ Time Frame: 12 months ]Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.
- Number of Participants With Cardiac Death and TVMI [ Time Frame: 12 months ]Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.
- Number of Participants With Major Adverse Cardiac Event (MACE) [ Time Frame: 12 months ]Major Adverse Cardiac Event (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically driven repeat target lesion revascularization by percutaneous or surgical methods.
- Number of Participants With Target Lesion Failure (TLF) [ Time Frame: 12 months ]Target Lesion Failure (TLF) 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 methods.
- Number of Participants With Stent Thrombosis (ARC) Definite/Probable [ Time Frame: 12 months ]
Stent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC).
Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration >20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.
Probable: Any unexplained death within the first 30 days.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria
- Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction
- Subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use, and the Declaration of Helsinki
- Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique
Exclusion Criteria:
- Unprotected left main disease
- Subjects with planned PCI of three vessel disease
- Planned two stent technique (main branch and side branch) of a bifurcation
- Subjects with more than one bifurcation lesion
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): NCT03584464
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Documents provided by Medtronic Vascular:
| Responsible Party: | Medtronic Vascular |
| ClinicalTrials.gov Identifier: | NCT03584464 |
| Other Study ID Numbers: |
V 4.0 16Feb2018 |
| First Posted: | July 12, 2018 Key Record Dates |
| Results First Posted: | January 12, 2022 |
| Last Update Posted: | October 12, 2022 |
| Last Verified: | October 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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Coronary Artery Disease Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |