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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bifurcation Cohort | Other | Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Device | Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cardiac Death | Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause. | 12 months |
| Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI) |
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Key Inclusion Criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville Hospital | Huntsville | Alabama | 35801-4421 | United States | ||
| Scripps Green Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bifurcation Cohort | Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 16, 2020 | Oct 18, 2021 |
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Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)
| Up to 12 months |
| Number of Participants With Target Lesion Revascularization (TLR) | 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. | 12 months |
| Number of Participants With Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) defined as revascularization of the target vessel. | 12 months |
| Number of Participants With Cardiac Death and TVMI | Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction. | 12 months |
| Number of Participants With Major Adverse Cardiac Event (MACE) | 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. | 12 months |
| Number of Participants With Target Lesion Failure (TLF) | 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. | 12 months |
| Number of Participants With Stent Thrombosis (ARC) Definite/Probable | 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. | 12 months |
| La Jolla |
| California |
| 92037 |
| United States |
| Riverside Community Hospital | Riverside | California | 92506-0102 | United States |
| Hartford Hospital | Hartford | Connecticut | 06106-5527 | United States |
| Morton Plant Hospital | Clearwater | Florida | 33756 | United States |
| North Florida Regional Medical Center | Gainesville | Florida | 32605-4524 | United States |
| Tallahassee Memorial Hospital | Tallahassee | Florida | 32308-4646 | United States |
| WellStar Kennestone Hospital | Marietta | Georgia | 30060-1125 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109-5869 | United States |
| Mercy Hospital | Coon Rapids | Minnesota | 55433-4568 | United States |
| Abbott Northwestern | Minneapolis | Minnesota | 55407-1195 | United States |
| Nebraska Medical Center | Omaha | Nebraska | 68198-2265 | United States |
| Desert Springs Hospital | Las Vegas | Nevada | 89118-3011 | United States |
| St. Josephs Hospital Health Center | East Syracuse | New York | 13057-9208 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| New York-Presbyterian Hospital/ Columbia University Medical Center | New York | New York | 10032-3729 | United States |
| Baptist Memorial Hospital-Memphis | Germantown | Tennessee | 38138-1727 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22903 | United States |
| Saint Vincent Hospital | Green Bay | Wisconsin | 54301 | United States |
| CHU Charleroi | Charleroi | 6042 | Belgium |
| Ziekenhuis Oost Limburg | Genk | 3600 | Belgium |
| CHU Toulouse - Hôpital Rangueil | Toulouse | 50032 31059 | France |
| Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s | Banská Bystrica | 97401 | Slovakia |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bifurcation Cohort | Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm in diameter for the treatment of a bifurcation lesion with provisional stenting. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Subjects did not provide this information | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | Subjects did not provide this information | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Target Vessel Failure (TVF) | Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods. | Posted | Count of Participants | Participants | 12 Months |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death | Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause. | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI) | Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI) | Posted | Count of Participants | Participants | Up to 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Revascularization (TLR) | 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. | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Vessel Revascularization (TVR) | Target Vessel Revascularization (TVR) defined as revascularization of the target vessel. | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cardiac Death and TVMI | Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction. | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Adverse Cardiac Event (MACE) | 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. | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Target Lesion Failure (TLF) | 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. | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Stent Thrombosis (ARC) Definite/Probable | 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. | Posted | Count of Participants | Participants | 12 months |
|
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bifurcation Cohort | Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort. Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm | 6 | 205 | 48 | 205 | 39 | 205 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Normocytic Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute Left Ventricular Failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Atrioventricular Block Second Degree | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Coronary Artery Dissection | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sinus Arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Diverticulum Intestinal | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rectal Haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 23.0 | Systematic Assessment | Site reported an unknown cause of death, therefore there is no known event that led to death. The event has been reviewed by our Safety Specialist and was adjudicated. |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular Stent Stenosis | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vessel Puncture Site Haematoma | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Drug Hypersensitivity | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Localised Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac Procedure Complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Postoperative Respiratory Failure | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Myocardial Necrosis Marker Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bladder Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Rectal Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Carotid Artery Stenosis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Unresponsive To Stimuli | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Carotid Endarterectomy | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
| |
| Coronary Artery Bypass | Surgical and medical procedures | MedDRA 23.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral Arterial Occlusive Disease | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Blood Loss Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bundle Branch Block Left | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Coronary Artery Dissection | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Coronary Artery Occlusion | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ventricular Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumoperitoneum | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Injection Site Haemorrhage | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vascular Stent Stenosis | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac Procedure Complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Face Injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Patella Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Periprocedural Myocardial Infarction | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Plaque Shift | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Vascular Access Complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Vascular Access Site Swelling | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Inflammatory Marker Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Myocardial Necrosis Marker Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Troponin I Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Troponin Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Intraductal Proliferative Breast Lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Urinary Retention | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Labile Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alissa Anderson, Clinical Study Manager | Medtronic, plc | 7075912434 | alissa.anderson@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 10, 2021 | Oct 18, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
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| >=65 years |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
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