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A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of abdominal aortic aneurysms (AAA).
The historical group is the open surgical repair procedures (n=323) in the Lifeline Foundation (now American Vascular Association Foundation).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AAA Repair System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aptus Endovascular AAA Repair System | Device | EVAR (endovascular aneurysm repair) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness: Composite Success Rate | Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%. | 12 months |
| Safety: MAE (Major Adverse Event) | Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: SAE (Serious Adverse Event) | Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure | 5 years |
| Effectiveness: Surgical Conversion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald M Fairman, M.D | University of Pennsylvania | Principal Investigator |
| Manish Mehta, M.D | Albany Medical College & Albany Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Vascular Group | Albany | New York | 12208 | United States | ||
| Hospital of the University of Pennsylvania |
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| ID | Title | Description |
|---|---|---|
| FG000 | AAA Repair System | Aptus Endovascular AAA Repair System: EVAR |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AAA Repair System | Aptus Endovascular AAA Repair System: EVAR |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Effectiveness: Composite Success Rate | Composite endpoint of delivery success, absence of Type I/III endoleak requiring intervention post-index procedure, absence of migration (>10mm), and absence of aneurysm rupture or conversion.This composite endpoint is compared to an estimated success rate of 80%. | Posted | Number | participants | 12 months |
|
|
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 | AAA Repair System | Aptus Endovascular AAA Repair System: EVAR |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin Schwartz | Medtronic Endovascular | (763) 514-4000 | kristin.schwartz@medtronic.com |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure.
Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device.
| 12 months |
| Effectiveness: Aneurysm Rupture | Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure | 12 months |
| Effectiveness: Aneurysm Change | Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure | 12 months |
| Effectiveness: EndoStaple Stent/Fracture | Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure | 12 months |
| Effectiveness: Prosthesis Migration | Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure | 12 months |
| Effectiveness: Type I Endoleak and Type III Endoleak | Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure | 12 months |
| Effectiveness: Thrombosis | Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure | 5 years |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Safety: MAE (Major Adverse Event) | Percentage (number) of subjects experiencing one or more of major adverse events within the first 30 days post-index procedure compared to the open surgical repair historical group | Posted | Number | participants | 30 days |
|
|
|
|
| Secondary | Safety: SAE (Serious Adverse Event) | Percent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure | Posted | Number | participants | 5 years |
|
|
|
| Secondary | Effectiveness: Surgical Conversion | Percent (number) of subjects undergoing surgical conversion through 12 months post-index procedure. Conversion is defined as the patient undergoing open surgical aneurysm repair with partial or complete removal of the study device. | 143 reflects the number of subjects with data for the 12 month visit. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Effectiveness: Aneurysm Rupture | Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure | 143 reflects the number of subjects with data for the 12 month visit. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Effectiveness: Aneurysm Change | Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of >5mm) at 12 months post-index procedure | Denominator is number of subjects with assessable imaging. Films are not assessable for aneurysm change if the 30-day scan is not available as a baseline. | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Effectiveness: EndoStaple Stent/Fracture | Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure | Denominator is number of subjects with adequate x-ray imaging available at 12 months | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Effectiveness: Prosthesis Migration | Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure | The denominator is the number of subjects with adequate CT imaging available at 12 months | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Effectiveness: Type I Endoleak and Type III Endoleak | Percent (number) of subjects experiencing type I endoleak (inadequate or ineffective seal of graft) or III endoleak (inadequate seal of graft joints or graft rupture) requiring intervention through 12 months post-index procedure | Denominator is the number of subjects with adequate CT imaging available at 12 months | Posted | Number | participants | 12 months |
|
|
|
| Secondary | Effectiveness: Thrombosis | Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure | Events classified by the clinical events committee as thrombosis in device, embolism, device occlusion, vascular occlusion and thrombosis were included in the number of patients affected | Posted | Number | participants | 5 years |
|
|
|
| 129 |
| 155 |
| 148 |
| 155 |
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Syncope | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Aorto-oesophageal fistula | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Peptic ulcer perforation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Device deployment issue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Device malfunction | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Device occlusion | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hernia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hernia obstructive | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Medical device complication | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Stent-graft endoleak | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Unevaluable event | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Clostridial infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Encephalitis viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Incision site cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Urinary retention postoperative | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Vascular injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Carcinoembryonic antigen increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Monarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Oropharyngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Small intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Multiple sclerosis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nephrotic syndrome | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Renal tubular necrosis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Aortic aneurysm repair | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Intestinal resection | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Large intestine operation | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Aneurysm ruptured | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Aortic stenosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arterial stenosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arteriosclerosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Embolism venous | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Femoral artery embolism | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Peripheral artery aneurysm | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Peripheral artery stenosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Peripheral artery thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Peripheral ischaemia | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vascular occlusion | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vascular stenosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Stent-graft endoleak | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Thrombosis in device | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Intermittent claudication | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
Not provided
Not provided
| D001018 |
| Aortic Diseases |