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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
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The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through the endpoints established in this protocol.
The clinical objective of the study is to evaluate the long term safety and effectiveness of the Endurant Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality (ARM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ENGAGE PAS De Novo Subjects | Experimental | The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endurant Stent Graft System | Device | The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days) | Aneurysm-Related Mortality (ARM) is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should be aneurysm related. > All deaths will be adjudicated by a Clinical Events Committee (CEC) to determine device, procedure and/or AAA relatedness. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Schermerhorn, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| Stanford Hospital & Clinics |
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| ID | Title | Description |
|---|---|---|
| FG000 | ENGAGE PAS De Novo Subjects | The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU). > > Endurant Stent Graft System: The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure. |
| 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 | Jun 11, 2013 | Dec 19, 2018 |
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|
| Stanford |
| California |
| 94305-5330 |
| United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06510-3220 | United States |
| Bayfront Medical Center | St. Petersburg | Florida | 33701-4814 | United States |
| Medical Center of Central Georgia (MCCG) | Macon | Georgia | 31201-2102 | United States |
| Mercy Hospital and Medical Center | Chicago | Illinois | 60616-2332 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702-4933 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215-5324 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756-1000 | United States |
| Morristown Memorial Hospital | Morristown | New Jersey | 07960-6136 | United States |
| WakeMed Health & Hospitals | Raleigh | North Carolina | 27610-1231 | United States |
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27103-3013 | United States |
| Sanford Medical Center Fargo | Fargo | North Dakota | 58122 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219-2906 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106-1716 | United States |
| Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | 18103 | United States |
| University of Pittsburgh Medical Center UPMC Shadyside | Pittsburgh | Pennsylvania | 15232-1311 | United States |
| Physicians Regional Medical Center | Knoxville | Tennessee | 37917-4556 | United States |
| Parkwest Medical Center | Knoxville | Tennessee | 37923-4325 | United States |
| Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Dallas | Texas | 75226-1316 | United States |
| CHI Saint Luke's Health - Baylor Saint Luke's Medical Center | Houston | Texas | 77030-2604 | United States |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908-0816 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042-3307 | United States |
| Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | 53215-3669 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ENGAGE PAS De Novo Subjects | The Endurant Stent Graft System Bifurcated device is administered to patients diagnosed with an abdominal aortic or aortoiliac aneurysm who are considered candidates for endovascular repair, per the FDA approved Instructions For Use (IFU). > > Endurant Stent Graft System: The Endurant Stent Graft System is designed to treat infrarenal abdominal aortic aneurysms using an endovascular approach. When placed within the aneurysm, the Endurant Stent Graft is designed to provide a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | 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 | Freedom From Aneurysm-related Mortality Rate (ARM) at 5 Years (1826 Days) | Aneurysm-Related Mortality (ARM) is defined as death from rupture of the abdominal aortic aneurysm or from any procedure intended to treat the Abdominal Aortic Aneurysm (AAA). If a death occurred within 30 days of any procedure intended to treat the AAA, then it is presumed to be aneurysm related unless there is evidence to the contrary. Deaths occurring after 30 days of any procedure intended to treat the AAA that are procedure-related should be aneurysm related. > All deaths will be adjudicated by a Clinical Events Committee (CEC) to determine device, procedure and/or AAA relatedness. | Posted | Number | 95% Confidence Interval | Proportion of Surviving | 5 years |
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|
|
5 Years
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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 | 1. Engage PAS | Medtronic Engage PAS De Novo Subjects | 48 | 178 | 86 | 178 | 15 | 178 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypercoagulation | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Red Blood Cell Abnormality | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiogenic Shock | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiopulmonary Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Cardiovascular Disorder | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Coronary Artery Disease | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Ventricular Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Gastrointestinal Necrosis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Retroperitoneal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Death | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Generalised Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Multi-Organ Failure | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Stent-Graft Endoleak | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Thrombosis In Device | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Unevaluable Event | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Toxicity To Various Agents | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Vascular Graft Occlusion | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Blood Creatinine Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Myelodysplastic Syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
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| Balance Disorder | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Cerebral Haemorrhage | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dementia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Hepatic Encephalopathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Metabolic Encephalopathy | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Mental Status Changes | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Artery Occlusion | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Artery Stenosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Failure Acute | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Infarct | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Tubular Necrosis | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Scrotal Oedema | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Tracheal Mass | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Aortic Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Arterial Haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Arterial Occlusive Disease | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Intermittent Claudication | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Peripheral Ischaemia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Shock Haemorrhagic | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thushari Alahapperuma | Medtronic | 763.526.8119 | thushari.r.alahapperuma@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 8, 2011 | Dec 19, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|