Trial Outcomes & Findings for Zenith TX2® Post-market Approval Study (NCT NCT00813358)
NCT ID: NCT00813358
Last Updated: 2021-06-04
Results Overview
Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
115 participants
Primary outcome timeframe
5 years
Results posted on
2021-06-04
Participant Flow
Participant milestones
| Measure |
Endovascular Repair
Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device
|
|---|---|
|
Overall Study
STARTED
|
115
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
69
|
Reasons for withdrawal
| Measure |
Endovascular Repair
Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device
|
|---|---|
|
Overall Study
Death
|
32
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
other endpoints
|
5
|
|
Overall Study
Withdrawal by Subject
|
20
|
Baseline Characteristics
Zenith TX2® Post-market Approval Study
Baseline characteristics by cohort
| Measure |
Endovascular Repair
n=115 Participants
treatment
Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
90 Participants
n=5 Participants
|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
93 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian - other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African Black or African American
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
115 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsThoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm.
Outcome measures
| Measure |
Endovascular Repair
n=115 Participants
Zenith® TX2® TAA Endovascular Graft through 5 years.
|
|---|---|
|
Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality
|
114 Participants
|
Adverse Events
Endovascular Repair
Serious events: 83 serious events
Other events: 14 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Endovascular Repair
n=115 participants at risk
treatment
Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
4.3%
5/115 • Number of events 6 • 5 years
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
CYTOPENIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Cardiac disorders
ARRHYTHMIA
|
3.5%
4/115 • Number of events 4 • 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
2.6%
3/115 • Number of events 3 • 5 years
|
|
Cardiac disorders
BRADYCARDIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Cardiac disorders
CARDIAC ARREST
|
2.6%
3/115 • Number of events 3 • 5 years
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
4.3%
5/115 • Number of events 5 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
3.5%
4/115 • Number of events 4 • 5 years
|
|
Cardiac disorders
PULSELESS ELECTRICAL ACTIVITY
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Congenital, familial and genetic disorders
CENTRAL NERVOUS SYSTEM EPIDERMOID TU
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Congenital, familial and genetic disorders
HYDROCELE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Ear and labyrinth disorders
DEAFNESS UNILATERAL
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Ear and labyrinth disorders
VERTIGO
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Eye disorders
VISION BLURRED
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
ENTEROCOLONIC FISTULA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
ENTEROCUTANEOUS FISTULA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
FEMORAL HERNIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX DISEASE
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
7.0%
8/115 • Number of events 11 • 5 years
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
NAUSEA
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
SPLENIC ARTERY ANEURYSM
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
General disorders
ASTHENIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
General disorders
CHEST DISCOMFORT
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
General disorders
CHEST PAIN
|
5.2%
6/115 • Number of events 6 • 5 years
|
|
General disorders
DEATH
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
General disorders
OEDEMA PERIPHERAL
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
General disorders
PHYSICAL DECONDITIONING
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
General disorders
PYREXIA
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
General disorders
STENT-GRAFT ENDOLEAK
|
4.3%
5/115 • Number of events 5 • 5 years
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Infections and infestations
ABDOMINAL WALL ABSCESS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
APPENDICITIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
BACTEREMIA
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Infections and infestations
CELLULITIS
|
1.7%
2/115 • Number of events 3 • 5 years
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE INFECTION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
EPIDIDYMITIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
MENINGITIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
OSTEOMYELITIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
PNEUMONIA
|
16.5%
19/115 • Number of events 19 • 5 years
|
|
Infections and infestations
PYELONEPHRITIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
SEPSIS
|
7.0%
8/115 • Number of events 8 • 5 years
|
|
Infections and infestations
STAPHYLOCOCCAL ABSCESS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
7.0%
8/115 • Number of events 12 • 5 years
|
|
Infections and infestations
URINARY TRACT INFECTION ENTEROCOCCAL
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
ARTERIAL BYPASS STENOSIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
FALL
|
2.6%
3/115 • Number of events 4 • 5 years
|
|
Injury, poisoning and procedural complications
INCOMPLETE SPINAL FUSION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Investigations
BLOOD CREATININE INCREASE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Investigations
ENDOBRONCHIAL ULTRASOUND
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Investigations
LABORATORY TEST ABNORMAL
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Investigations
TROPONIN INCREASED
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
GOUT
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
0.87%
1/115 • Number of events 2 • 5 years
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.6%
3/115 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SACROILIAC JOINT DYSFUNCTION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC MYELOID LEUKEMIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCOAST'S TUMOUR
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Nervous system disorders
BRAIN INJURY
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Nervous system disorders
CAROTID ARTERY OCCLUSION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
5.2%
6/115 • Number of events 7 • 5 years
|
|
Nervous system disorders
PARAPARESIS
|
2.6%
3/115 • Number of events 3 • 5 years
|
|
Nervous system disorders
PARAPLEGIA
|
3.5%
4/115 • Number of events 4 • 5 years
|
|
Nervous system disorders
SEIZURE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Nervous system disorders
SEIZURES
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Nervous system disorders
SPINAL CORD ISCHAEMIA
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
2.6%
3/115 • Number of events 3 • 5 years
|
|
Product Issues
DEVICE KINK
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Product Issues
MEDICAL DEVICE ENTRAPMENT
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
CHRONIC KIDNEY DISEASE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
HAEMATURIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
URETEROLITHIASIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
CYSTOCELE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
AORTO-BRONCHIAL FISTULA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL SECRETION RETENTION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEAS
|
4.3%
5/115 • Number of events 8 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.6%
3/115 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MASS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
2.6%
3/115 • Number of events 3 • 5 years
|
|
Surgical and medical procedures
CRANIOTOMY
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
INCARCERATED HERNIA REPAIR
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
INTESTINAL RESECTION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
MECHANICAL VENTILATION
|
4.3%
5/115 • Number of events 5 • 5 years
|
|
Surgical and medical procedures
OXYGEN THERAPY
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
PANCREATECTOMY
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
PERIPHERAL ENDARTERECTOMY
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
PULMONARY RESECTION
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Surgical and medical procedures
VASCULAR GRAFT
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Vascular disorders
ANEURYSM RUPTURED
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Vascular disorders
AORTIC ANEURYSM
|
2.6%
3/115 • Number of events 3 • 5 years
|
|
Vascular disorders
AORTIC DISSECTION
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Vascular disorders
AORTIC INTRAMURAL HAEMATOMA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Vascular disorders
ARTERIAL THROMBOSIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Vascular disorders
HYPERTENSION
|
3.5%
4/115 • Number of events 4 • 5 years
|
|
Vascular disorders
INTERMITTENT CLAUDICATION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Vascular disorders
PERIPHERAL ARTERY ANEURYSM
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Vascular disorders
PERIPHERAL ARTERY ANEURYSM RUPTURE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Vascular disorders
PERIPHERAL ARTERY OCCLUSION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Vascular disorders
PERIPHERAL EMBOLISM
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Vascular disorders
SUBCLAVIAN ARTERY OCCLUSION
|
1.7%
2/115 • Number of events 2 • 5 years
|
|
Vascular disorders
THROMBOSIS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
VOMITING
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
CELLULITIS STAPHYLOCOCCAL
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Infections and infestations
ESCHERICHIA INFECTION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
COMPRESSION FRACTURE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.87%
1/115 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
STERNAL FRACTURE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
HYPERNATRAEMIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
KNEE DEFORMITY
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Nervous system disorders
DIZZINESS
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
KETONURIA
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
STRESS URINARY INCONTINENCE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
RECTOCELE
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
SPLENECTOMY
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Vascular disorders
ANEURYSM
|
0.87%
1/115 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
VAGINAL PROLAPSE
|
0.87%
1/115 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Endovascular Repair
n=115 participants at risk
treatment
Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device
|
|---|---|
|
Cardiac disorders
ARRHYTHMIA
|
5.2%
6/115 • Number of events 6 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.7%
10/115 • Number of events 12 • 5 years
|
Additional Information
Alan Saunders, MS, RAC; Manager, Biostatistics
Cook Research Incorporated
Phone: 765-463-7537
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60