Trial Outcomes & Findings for TX2® Low Profile TAA Endovascular Graft (NCT NCT01151020)
NCT ID: NCT01151020
Last Updated: 2021-01-22
Results Overview
Major adverse event is defined as: All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation \> 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
30 days
Results posted on
2021-01-22
Participant Flow
Participant milestones
| Measure |
Zenith® TX2® Low Profile TAA Endovascular Graft
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
|
|---|---|
|
Overall Study
STARTED
|
110
|
|
Overall Study
30-day
|
110
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
54
|
Reasons for withdrawal
| Measure |
Zenith® TX2® Low Profile TAA Endovascular Graft
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
|
|---|---|
|
Overall Study
Death
|
25
|
|
Overall Study
Conversion to open repair
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Withdrawal by Subject
|
22
|
|
Overall Study
Patients did not receive the device
|
2
|
Baseline Characteristics
TX2® Low Profile TAA Endovascular Graft
Baseline characteristics by cohort
| Measure |
Zenith® TX2® Low Profile TAA Endovascular Graft
n=110 Participants
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
|
|---|---|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 1 patient had a stroke and required ventilation \>72 hours/reintubation.
Major adverse event is defined as: All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation \> 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room.
Outcome measures
| Measure |
Zenith® TX2® Low Profile TAA Endovascular Graft
n=110 Participants
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
|
|---|---|
|
Patients With Major Adverse Events (MAE)
Stroke
|
2 participants
|
|
Patients With Major Adverse Events (MAE)
Ventilation >72 hours/reintubation
|
3 participants
|
PRIMARY outcome
Timeframe: 12 monthsDevice failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.
Outcome measures
| Measure |
Zenith® TX2® Low Profile TAA Endovascular Graft
n=110 Participants
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
|
|---|---|
|
Patients With Device Failures
Aneurysm growth>5 mm and conversion to open repair
|
1 participants
|
|
Patients With Device Failures
Did not receive the device (technical failures)
|
2 participants
|
|
Patients With Device Failures
Aneurysm growth>5 mm
|
2 participants
|
|
Patients With Device Failures
Endoleak requiring secondary intervention
|
3 participants
|
Adverse Events
Zenith® TX2® Low Profile TAA Endovascular Graft
Serious events: 86 serious events
Other events: 0 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Zenith® TX2® Low Profile TAA Endovascular Graft
n=110 participants at risk
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
|
|---|---|
|
Blood and lymphatic system disorders
coagulopathy
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Cardiac disorders
Arrhythmia
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Cardiac disorders
angina pectoris
|
0.91%
1/110 • Number of events 2 • 5 years
|
|
Cardiac disorders
cardiac arrest
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Cardiac disorders
cardiac failure congestive
|
4.5%
5/110 • Number of events 5 • 5 years
|
|
Cardiac disorders
myocardial infarction
|
5.5%
6/110 • Number of events 7 • 5 years
|
|
Cardiac disorders
myocardial ischaemia
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Cardiac disorders
ventricular tachycardai
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
3.6%
4/110 • Number of events 4 • 5 years
|
|
Gastrointestinal disorders
aorto-oesophageal fistula
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
dysphagia
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
ileus
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
inguinal hernia
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
pneumoperitoneum
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
brain contusion
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
femoral neck fracture
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
foreign body
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
incisional hernia
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
injury
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
patella fracture
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
spinal compression fracture
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
subdural hematoma
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
compartment syndrome
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
spinal ligament ossification
|
0.91%
1/110 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
spinal osteoarthritis
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage II
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bladder cancer recurrent
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
colon adenoma
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
colon cancer
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
gastric cancer
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
Eye disorders
blindness unilateral
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Eye disorders
cataract
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
abdominal pain lower
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
gastrointestinal haemorrhage
|
4.5%
5/110 • Number of events 5 • 5 years
|
|
Gastrointestinal disorders
intestinal obstruction
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
oesophageal dysplasia
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
pelvic floor dysfunction
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
small intestinal obstruction
|
2.7%
3/110 • Number of events 3 • 5 years
|
|
General disorders
chest pain
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
General disorders
multiple organ dysfunction syndrome
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
General disorders
stent-graft endoleak
|
6.4%
7/110 • Number of events 7 • 5 years
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Immune system disorders
anaphylactic reaction
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Immune system disorders
contrast media allergy
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
abdominal wall abscess
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
abdominal wall infection
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
arthritis bacterial
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
diverticulitis
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
diverticulitis intestinal perforated
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
gastroenteritis
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
gastrointestinal infection
|
4.5%
5/110 • Number of events 5 • 5 years
|
|
Infections and infestations
infection
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
influenza
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
pneumonia
|
10.9%
12/110 • Number of events 13 • 5 years
|
|
Infections and infestations
sepsis
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
Infections and infestations
urinary tract infection
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
fall
|
2.7%
3/110 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
post laminectomy syndrome
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
pseudoaneurysm
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
respiratory fume inhalation disorder
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
spinal column injury
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Investigations
blood creatinine increased
|
2.7%
3/110 • Number of events 3 • 5 years
|
|
Metabolism and nutrition disorders
gout
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
malnutrition
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
joint swelling
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
lumbar spinal stenosis
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
rotator cuff syndrome
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
non-small cell lung cancer
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
skin cancer
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Nervous system disorders
Generalized tonic-clonic seizure
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Nervous system disorders
aphasia
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Nervous system disorders
carotid artery stenosis
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Nervous system disorders
cerebrovascular accident
|
7.3%
8/110 • Number of events 8 • 5 years
|
|
Nervous system disorders
paraparesis
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Nervous system disorders
parkinsonism
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Nervous system disorders
syncope
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
Product Issues
device electrical finding
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Psychiatric disorders
delirium
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
calculus urinary
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
chronic kidney disease
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
renal failure
|
5.5%
6/110 • Number of events 7 • 5 years
|
|
Renal and urinary disorders
urinary incontinence
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
prostatitis
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
aorto-bronchial fistula
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
bronchial secretion retention
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
haemoptysis
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia aspiration
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary haematoma
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
Surgical and medical procedures
Soft tissue excision
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
craniotomy
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
percutaneous coronary intervention
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Vascular disorders
Aneurysm
|
12.7%
14/110 • Number of events 15 • 5 years
|
|
Vascular disorders
aortic aneurysm
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
Vascular disorders
embolism
|
2.7%
3/110 • Number of events 3 • 5 years
|
|
Vascular disorders
haematoma
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Vascular disorders
haemmorrhage
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Vascular disorders
hypertension
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Vascular disorders
hypotension
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Vascular disorders
iliac artery occlusion
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Vascular disorders
iliac artery stenosis
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
Vascular disorders
ischaemia
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Vascular disorders
peripheral arterial occlusive disease
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Vascular disorders
peripheral artery occlusion
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Vascular disorders
vascular dissection
|
2.7%
3/110 • Number of events 3 • 5 years
|
|
Vascular disorders
vascular rupture
|
2.7%
3/110 • Number of events 3 • 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.91%
1/110 • Number of events 3 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMATOMA
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
General disorders
DEATH
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
General disorders
VASCULAR STENT THROMBOSIS
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
OSTEOMYELITIS
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
HERPES ZOSTER
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Infections and infestations
ABSCESS LIMB
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMMORRHAGE
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BONE METABOLISM DISORDER
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE RUPTURE
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
POLYMYALGIA RHEUMATICA
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
URETHRAL STENOSIS
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.8%
2/110 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
LUNG OPACITY
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
STASIS DERMATITIS
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
MEDICAL DEVICE REMOVAL
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
RENAL DISORDER PROPHYLAXIS
|
1.8%
2/110 • Number of events 3 • 5 years
|
|
Surgical and medical procedures
STENT PLACEMENT
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL ADHESIONS
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
PAPILLA OF VATER STENOSIS
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
MULTIPLE FRACTURES
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
BURSITIS
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DEPENDENCE ON VENTILATOR
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.91%
1/110 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
NAUSEA
|
0.91%
1/110 • Number of events 1 • 5 years
|
Other adverse events
Adverse event data not reported
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