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The purpose of this study is to examine, through the endpoints established in this protocol, the long-term safety and effectiveness of the Talent Abdominal Stent Graft System, in a post-approval environment.
The Talent Abdominal Stent Graft System is a next-generation modular system for endovascular repair of Abdominal Aortic Aneurysm (AAA). The system was designed with the following enhancements: a suprarenal wire frame to provide migration resistance, and improved flexibility designed to treat difficult anatomies.
Medtronic Vascular submitted a Pre-Market Application (PMA) to the Food and Drug Administration (FDA) on October 17, 2007, and received market approval for the Talent Abdominal Stent Graft System on April 15th, 2008. As a condition of approval, the FDA has requested a post-approval study. Medtronic has therefore designed a post-approval study, in collaboration with FDA, to document the performance of the Talent Abdominal Stent Graft System under market conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Talent Abdominal Stent Graft | Device | The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Aneurysm-related Mortality (ARM) | 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 also be aneurysm related. All deaths were adjudicated by a Clinical Events Committee (CEC) to determine aneurysm, device and/or procedure relatedness. | 5 year Kaplan Meier (KM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Sanchez, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Univerisity Hospital | Los Angeles | California | 90033 | United States | ||
| Palo Alto VAMC |
166 subjects were enrolled in the previous cohort study (NCT # is not available). 94 subjects were enrolled into the Vitality study. When these two cohorts are combined it totals 260. The Vitality study collected information on its 94 enrolled subjects, but for study analysis both cohorts were combined.
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| ID | Title | Description |
|---|---|---|
| FG000 | Talent Abdominal Stent Graft | Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the Food and Drug Administration (FDA) approved Instructions for Use (IFU). > > Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Palo Alto |
| California |
| 94304 |
| United States |
| Christiana Care Health Services | Newark | Delaware | 19713 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| St. John's Medical Research Institute | Springfield | Missouri | 65810 | United States |
| Barnes Jewish | St Louis | Missouri | 63110 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
| Lehigh Valley Hospital | Allentown | Pennsylvania | 18103 | United States |
| Pinnacle Health Network | Harrisburg | Pennsylvania | 17110 | United States |
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57104 | United States |
| North Central Heart Institute | Sioux Falls | South Dakota | 57108 | United States |
| St. Mary's Medical Center | Knoxville | Tennessee | 37923 | United States |
| Vanderbilt Vascular Surgery | Nashville | Tennessee | 37232 | United States |
| Wilford Hall Medical Center | Lackland Air Force Base | Texas | 78236 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Charleston Area Medical Center | Charleston | West Virginia | 23504 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU.> > Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement. |
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Freedom From Aneurysm-related Mortality (ARM) | 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 also be aneurysm related. All deaths were adjudicated by a Clinical Events Committee (CEC) to determine aneurysm, device and/or procedure relatedness. | All enrolled subjects. | Posted | Number | 95% Confidence Interval | Proportion of participants | 5 year Kaplan Meier (KM) |
|
|
|
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 | 1. Vitality | Medtronic Vitality | 31 | 94 | 5 | 94 | ||
| EG001 | 2. ELPS | Medtronic ELPS | 99 | 166 | 112 | 166 |
| 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 |
| |
| Heparin-Induced Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac Valve Disease | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiovascular Disorder | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Coronary Artery Disease | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Mitral Valve Incompetence | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Duodenal Ulcer Perforation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Inguinal Hernia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Intestinal Ischaemia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Intestinal Mass | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Large Intestine Perforation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Retroperitoneal Fibrosis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Catheter Site Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Device Deployment Issue | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Device Dislocation | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Device Kink | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hernia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ill-Defined Disorder | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Medical Device Complication | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Stent Malfunction | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Stent-Graft Endoleak | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hepatic Cyst | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hepatic Lesion | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Candida Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Groin Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Incision Site Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Anaemia Postoperative | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Arterial Injury | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Extradural Haematoma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Pelvic Fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Creatinine Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood Glucose Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Catheterisation Cardiac | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Haematocrit Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Haemoglobin Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Laboratory Test Abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Platelet Count Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Popliteal Pulse Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Red Blood Cell Analysis Abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Urine Analysis Abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Intervertebral Disc Degeneration | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscle Tightness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Adrenal Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Bladder Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Gastrointestinal Stromal Tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Lung Squamous Cell Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Metastatic Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Skin Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Throat Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
| |
| Carotid Artery Stenosis | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Delirium Tremens | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Libido Decreased | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Artery Occlusion | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Disorder | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Impairment | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Infarct | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Ischaemia | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Genital Pain | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pelvic Fluid Collection | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Productive Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Decubitus Ulcer | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Cardiac Pacemaker Insertion | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral Artery Bypass | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Artery Angioplasty | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Surgery | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Ureteric Calculus Removal | Surgical and medical procedures | MedDRA 10.0 | Systematic Assessment |
| |
| Aneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Aortic Aneurysm | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Aortic Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Aortic Stenosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Arterial Occlusive Disease | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Intermittent Claudication | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Peripheral Artery Dissection | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Vascular Occlusion | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Ill-Defined Disorder | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Stent-Graft Endoleak | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require deletion of confidential information.The sponsor cannot require changes beyond those necessary to protect confidential information. The sponsor cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rianna Rapson | Medtronic | 7635262170 | rianna.k.rapson@medtronic.com |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|