Zenith TX2® Post-market Approval Study | NCT00813358

ID	Type	Description	Link
370024, 2PAS

Label	Type	Description	Intervention Names
Endovascular repair	Experimental	treatment	Device: Zenith TX2® TAA Endovascular Graft

Name	Type	Description	Arm Group Labels	Other Names
Zenith TX2® TAA Endovascular Graft	Device	Endovascular treatment with the study device	Endovascular repair

Measure	Description	Time Frame
Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality	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.	5 years

Facility	Status	City	State	ZIP	Country	Contacts
Kaiser Permanente		San Francisco	California	94115	United States
University of Denver Colorado

ID	Title	Description
FG000	Endovascular Repair	Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Mar 14, 2018

ID	Title	Description
BG000	Endovascular Repair	treatment Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device

Units	Counts
Participants	BG000115

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	Systematic Assessment	EG0006 events5 affected115 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CYTOPENIA	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected115 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected115 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	Systematic Assessment	EG0001 events1 affected115 at risk
ARRHYTHMIA	Cardiac disorders	Systematic Assessment	EG0004 events4 affected115 at risk
ATRIAL FIBRILLATION	Cardiac disorders	Systematic Assessment	EG0003 events3 affected115 at risk
BRADYCARDIA	Cardiac disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CARDIAC ARREST	Cardiac disorders	Systematic Assessment	EG0003 events3 affected115 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	Systematic Assessment	EG0005 events5 affected115 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	Systematic Assessment	EG0001 events1 affected115 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	Systematic Assessment	EG0004 events4 affected115 at risk
PULSELESS ELECTRICAL ACTIVITY	Cardiac disorders	Systematic Assessment	EG0001 events1 affected115 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CENTRAL NERVOUS SYSTEM EPIDERMOID TU	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected115 at risk
HYDROCELE	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected115 at risk
DEAFNESS UNILATERAL	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected115 at risk
VERTIGO	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected115 at risk
VISION BLURRED	Eye disorders	Systematic Assessment	EG0001 events1 affected115 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
DYSPHAGIA	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
ENTEROCOLONIC FISTULA	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
ENTEROCUTANEOUS FISTULA	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
FEMORAL HERNIA	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
GASTROESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected115 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	Systematic Assessment	EG00011 events8 affected115 at risk
ILEUS PARALYTIC	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
INGUINAL HERNIA	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
NAUSEA	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected115 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected115 at risk
SPLENIC ARTERY ANEURYSM	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
ASTHENIA	General disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CHEST DISCOMFORT	General disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CHEST PAIN	General disorders	Systematic Assessment	EG0006 events6 affected115 at risk
DEATH	General disorders	Systematic Assessment	EG0001 events1 affected115 at risk
NON-CARDIAC CHEST PAIN	General disorders	Systematic Assessment	EG0002 events2 affected115 at risk
OEDEMA PERIPHERAL	General disorders	Systematic Assessment	EG0001 events1 affected115 at risk
PHYSICAL DECONDITIONING	General disorders	Systematic Assessment	EG0001 events1 affected115 at risk
PYREXIA	General disorders	Systematic Assessment	EG0002 events2 affected115 at risk
STENT-GRAFT ENDOLEAK	General disorders	Systematic Assessment	EG0005 events5 affected115 at risk
BILE DUCT STONE	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CHOLECYSTITIS	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected115 at risk
HEPATIC FAILURE	Hepatobiliary disorders	Systematic Assessment	EG0002 events2 affected115 at risk
ABDOMINAL WALL ABSCESS	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
APPENDICITIS	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
BACTEREMIA	Infections and infestations	Systematic Assessment	EG0002 events2 affected115 at risk
CELLULITIS	Infections and infestations	Systematic Assessment	EG0003 events2 affected115 at risk
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
DEVICE RELATED INFECTION	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
EPIDIDYMITIS	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
GASTROINTESTINAL INFECTION	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
MENINGITIS	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
OSTEOMYELITIS	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
PNEUMONIA	Infections and infestations	Systematic Assessment	EG00019 events19 affected115 at risk
PYELONEPHRITIS	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
SEPSIS	Infections and infestations	Systematic Assessment	EG0008 events8 affected115 at risk
STAPHYLOCOCCAL ABSCESS	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	Systematic Assessment	EG0002 events2 affected115 at risk
URINARY TRACT INFECTION	Infections and infestations	Systematic Assessment	EG00012 events8 affected115 at risk
URINARY TRACT INFECTION ENTEROCOCCAL	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
ARTERIAL BYPASS STENOSIS	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
FALL	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 events3 affected115 at risk
INCOMPLETE SPINAL FUSION	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
OVERDOSE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected115 at risk
BLOOD CREATININE INCREASE	Investigations	Systematic Assessment	EG0001 events1 affected115 at risk
ENDOBRONCHIAL ULTRASOUND	Investigations	Systematic Assessment	EG0001 events1 affected115 at risk
LABORATORY TEST ABNORMAL	Investigations	Systematic Assessment	EG0001 events1 affected115 at risk
TROPONIN INCREASED	Investigations	Systematic Assessment	EG0001 events1 affected115 at risk
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected115 at risk
GOUT	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected115 at risk
HYPERGLYCEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected115 at risk
HYPOGLYCEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events1 affected115 at risk
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected115 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected115 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected115 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected115 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected115 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected115 at risk
SACROILIAC JOINT DYSFUNCTION	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected115 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected115 at risk
CHRONIC MYELOID LEUKEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected115 at risk
PANCOAST'S TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected115 at risk
BRAIN INJURY	Nervous system disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CAROTID ARTERY OCCLUSION	Nervous system disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	Systematic Assessment	EG0007 events6 affected115 at risk
PARAPARESIS	Nervous system disorders	Systematic Assessment	EG0003 events3 affected115 at risk
PARAPLEGIA	Nervous system disorders	Systematic Assessment	EG0004 events4 affected115 at risk
SEIZURE	Nervous system disorders	Systematic Assessment	EG0001 events1 affected115 at risk
SEIZURES	Nervous system disorders	Systematic Assessment	EG0001 events1 affected115 at risk
SPINAL CORD ISCHAEMIA	Nervous system disorders	Systematic Assessment	EG0002 events2 affected115 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	Systematic Assessment	EG0003 events3 affected115 at risk
DEVICE KINK	Product Issues	Systematic Assessment	EG0001 events1 affected115 at risk
MEDICAL DEVICE ENTRAPMENT	Product Issues	Systematic Assessment	EG0001 events1 affected115 at risk
BIPOLAR DISORDER	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected115 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected115 at risk
HAEMATURIA	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected115 at risk
NEPHROLITHIASIS	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected115 at risk
RENAL FAILURE	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected115 at risk
URETEROLITHIASIS	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CYSTOCELE	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected115 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
AORTO-BRONCHIAL FISTULA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
ASPIRATION	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
BRONCHIAL SECRETION RETENTION	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEAS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0008 events5 affected115 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected115 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected115 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected115 at risk
PULMONARY HAEMORRHAGE	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
PULMONARY MASS	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected115 at risk
CRANIOTOMY	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected115 at risk
INCARCERATED HERNIA REPAIR	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected115 at risk
INTESTINAL RESECTION	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected115 at risk
MECHANICAL VENTILATION	Surgical and medical procedures	Systematic Assessment	EG0005 events5 affected115 at risk
OXYGEN THERAPY	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected115 at risk
PANCREATECTOMY	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected115 at risk
PERIPHERAL ENDARTERECTOMY	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected115 at risk
PULMONARY RESECTION	Surgical and medical procedures	Systematic Assessment	EG0002 events2 affected115 at risk
VASCULAR GRAFT	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected115 at risk
ANEURYSM RUPTURED	Vascular disorders	Systematic Assessment	EG0001 events1 affected115 at risk
AORTIC ANEURYSM	Vascular disorders	Systematic Assessment	EG0003 events3 affected115 at risk
AORTIC DISSECTION	Vascular disorders	Systematic Assessment	EG0002 events2 affected115 at risk
AORTIC INTRAMURAL HAEMATOMA	Vascular disorders	Systematic Assessment	EG0001 events1 affected115 at risk
ARTERIAL THROMBOSIS	Vascular disorders	Systematic Assessment	EG0001 events1 affected115 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	Systematic Assessment	EG0002 events2 affected115 at risk
HYPERTENSION	Vascular disorders	Systematic Assessment	EG0004 events4 affected115 at risk
INTERMITTENT CLAUDICATION	Vascular disorders	Systematic Assessment	EG0001 events1 affected115 at risk
PERIPHERAL ARTERY ANEURYSM	Vascular disorders	Systematic Assessment	EG0001 events1 affected115 at risk
PERIPHERAL ARTERY ANEURYSM RUPTURE	Vascular disorders	Systematic Assessment	EG0001 events1 affected115 at risk
PERIPHERAL ARTERY OCCLUSION	Vascular disorders	Systematic Assessment	EG0001 events1 affected115 at risk
PERIPHERAL EMBOLISM	Vascular disorders	Systematic Assessment	EG0002 events2 affected115 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	Systematic Assessment	EG0001 events1 affected115 at risk
SUBCLAVIAN ARTERY OCCLUSION	Vascular disorders	Systematic Assessment	EG0002 events2 affected115 at risk
THROMBOSIS	Vascular disorders	Systematic Assessment	EG0001 events1 affected115 at risk
VOMITING	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
CELLULITIS STAPHYLOCOCCAL	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
ESCHERICHIA INFECTION	Infections and infestations	Systematic Assessment	EG0001 events1 affected115 at risk
COMPRESSION FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
CONCUSSION	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events1 affected115 at risk
STERNAL FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected115 at risk
HYPERNATRAEMIA	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected115 at risk
KNEE DEFORMITY	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected115 at risk
DIZZINESS	Nervous system disorders	Systematic Assessment	EG0001 events1 affected115 at risk
KETONURIA	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected115 at risk
STRESS URINARY INCONTINENCE	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected115 at risk
URINARY TRACT OBSTRUCTION	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected115 at risk
RECTOCELE	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected115 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected115 at risk
SPLENECTOMY	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected115 at risk
ANEURYSM	Vascular disorders	Systematic Assessment	EG0001 events1 affected115 at risk
VAGINAL PROLAPSE	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected115 at risk

ID	Term
D017545	Aortic Aneurysm, Thoracic
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases

ID	Term
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019917	Blood Vessel Prosthesis Implantation
D058017	Vascular Grafting
D019060	Minimally Invasive Surgical Procedures
D019919	Prosthesis Implantation

ID	Term
D000094627	Descending Thoracic Aortic Aneurysm
D001014	Aortic Aneurysm