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The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Other | Medtronic Resolute Onyx Zotarolimus-Eluting Stent System |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resolute Onyx Stent - 2.25 mm - 4.0 mm | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography | In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography | 8 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Death | 8 Months | |
| Target Vessel Myocardial Infarction (TVMI) | 8 Months | |
| Target Lesion Revascularization (TLR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew J. Price, MD, FACC, FSCAI | Scripps Green Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Green Hospital | La Jolla | California | 92037 | United States | ||
| Morton Plant Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Device | Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Resolute Onyx Stent - 2.25 mm - 4.0 mm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 8 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 | 8 Months |
| Target Lesion Failure (TLF) | 8 Months |
| Target Vessel Failure (TVF) | 8 Months |
| Stent Thrombosis (ST) | 8 Months |
| Cardiac Death and TVMI | 8 Months |
| Clearwater |
| Florida |
| 33756 |
| United States |
| Saint John's Hospital | Springfield | Illinois | 62701 | United States |
| St. Vincent Heart Center of Indiana | Indianapolis | Indiana | 46290 | United States |
| Saint Francis Hospital | Roslyn | New York | 11576 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| Sanford Medical Center | Fargo | North Dakota | 58122 | United States |
| University Hospitals Elyria Medical Center | Elyria | Ohio | 44035 | United States |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | United States |
| AnMed Health Medical Center | Anderson | South Carolina | 29621 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37205 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Device | Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Resolute Onyx Stent - 2.25 mm - 4.0 mm |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography | In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography | Posted | Mean | Standard Deviation | mm | 8 Months |
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| Secondary | Cardiac Death | Posted | Count of Participants | Participants | 8 Months |
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| Secondary | Target Vessel Myocardial Infarction (TVMI) | Posted | Count of Participants | Participants | 8 Months |
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| Secondary | Target Lesion Revascularization (TLR) | Posted | Count of Participants | Participants | 8 Months |
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| Secondary | 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 | 8 Months |
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| Secondary | Target Lesion Failure (TLF) | Posted | Count of Participants | Participants | 8 Months |
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| Secondary | Target Vessel Failure (TVF) | Posted | Count of Participants | Participants | 8 Months |
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| Secondary | Stent Thrombosis (ST) | Posted | Count of Participants | Participants | 8 Months |
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| Secondary | Cardiac Death and TVMI | Posted | Count of Participants | Participants | 8 Months |
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All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
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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 | Device | Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Resolute Onyx Stent - 2.25 mm - 4.0 mm | 27 | 75 | 66 | 75 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | Systematic Assessment |
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| Angina Unstable | Cardiac disorders | Systematic Assessment |
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| Atrial Flutter | Cardiac disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | Systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | Systematic Assessment |
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| Coronary Artery Perforation | Cardiac disorders | Systematic Assessment |
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| Coronary Artery Stenosis | Cardiac disorders | Systematic Assessment |
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| Coronary Artery Thrombosis | Cardiac disorders | Systematic Assessment |
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| In-Stent Coronary Artery Restenosis | Cardiac disorders | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Supraventricular Extrasystoles | Cardiac disorders | Systematic Assessment |
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| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
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| Thyroid Disorder | Endocrine disorders | Systematic Assessment |
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| Inguinal Hernia | Gastrointestinal disorders | Systematic Assessment |
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| Rectal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Puncture Site Haemorrhage | General disorders | Systematic Assessment |
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| Bile Duct Stone | Hepatobiliary disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| In-Stent Arterial Restenosis | Injury, poisoning and procedural complications | Systematic Assessment |
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| Cardiac Enzymes Increased | Investigations | Systematic Assessment |
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| Liver Function Test Abnormal | Investigations | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Benign Neoplasm Of Thyroid Gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Hepatic Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Therapeutic Embolisation | Surgical and medical procedures | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Orthostatic Hypotension | Vascular disorders | Systematic Assessment |
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| Peripheral Arterial Occlusive Disease | Vascular disorders | Systematic Assessment |
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| Shock Haemorrhagic | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | Systematic Assessment |
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| Cardiac Enzymes Increased | Investigations | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Beth Moe, Clinical Study Manager | Medtronic Coronary Structual Heart | beth.moe@medtronic.com |
| 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 |
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