Trial Outcomes & Findings for The Pivotal Study of the Aptus Endovascular AAA Repair System (NCT NCT00507559)
NCT ID: NCT00507559
Last Updated: 2021-11-03
Results Overview
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%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
155 participants
Primary outcome timeframe
12 months
Results posted on
2021-11-03
Participant Flow
Participant milestones
| Measure |
AAA Repair System
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Overall Study
STARTED
|
155
|
|
Overall Study
COMPLETED
|
84
|
|
Overall Study
NOT COMPLETED
|
71
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Pivotal Study of the Aptus Endovascular AAA Repair System
Baseline characteristics by cohort
| Measure |
AAA Repair System
n=155 Participants
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Age, Continuous
|
73 years
STANDARD_DEVIATION 8 • n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
155 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 12 monthsComposite 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%.
Outcome measures
| Measure |
AAA Repair System
n=155 Participants
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Effectiveness: Composite Success Rate
|
4 participants
|
PRIMARY outcome
Timeframe: 30 daysPercentage (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
Outcome measures
| Measure |
AAA Repair System
n=155 Participants
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Safety: MAE (Major Adverse Event)
|
3 participants
|
SECONDARY outcome
Timeframe: 5 yearsPercent (number) of subjects experiencing one or more serious adverse event through 5 years post-index procedure
Outcome measures
| Measure |
AAA Repair System
n=155 Participants
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Safety: SAE (Serious Adverse Event)
|
129 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 143 reflects the number of subjects with data for the 12 month visit.
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.
Outcome measures
| Measure |
AAA Repair System
n=143 Participants
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Effectiveness: Surgical Conversion
|
1 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 143 reflects the number of subjects with data for the 12 month visit.
Percent (number) of subjects experiencing aneurysm rupture through 12 months post-index procedure
Outcome measures
| Measure |
AAA Repair System
n=143 Participants
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Effectiveness: Aneurysm Rupture
|
1 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 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.
Percent (number) of subjets experiencing aneurysm change (defined as increase in maximum diameter of \>5mm) at 12 months post-index procedure
Outcome measures
| Measure |
AAA Repair System
n=132 Participants
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Effectiveness: Aneurysm Change
|
2 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Denominator is number of subjects with adequate x-ray imaging available at 12 months
Percent (number) of subjects experiencing an EndoStaple stent/fracture at 12 months post-index procedure
Outcome measures
| Measure |
AAA Repair System
n=119 Participants
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Effectiveness: EndoStaple Stent/Fracture
|
0 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The denominator is the number of subjects with adequate CT imaging available at 12 months
Percent (number) of subjects experiencing prothesis migration at 12 months post-index procedure
Outcome measures
| Measure |
AAA Repair System
n=133 Participants
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Effectiveness: Prosthesis Migration
|
0 participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Denominator is the number of subjects with adequate CT imaging available at 12 months
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
Outcome measures
| Measure |
AAA Repair System
n=132 Participants
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Effectiveness: Type I Endoleak and Type III Endoleak
|
2 participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: 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
Percent (number) of subjects experiencing thrombosis through 5 years post-index procedure
Outcome measures
| Measure |
AAA Repair System
n=155 Participants
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Effectiveness: Thrombosis
|
64 participants
|
Adverse Events
AAA Repair System
Serious events: 129 serious events
Other events: 148 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AAA Repair System
n=155 participants at risk
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
General disorders
Death
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
General disorders
Device deployment issue
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
General disorders
Device dislocation
|
1.9%
3/155 • Number of events 3 • 5 years
|
|
General disorders
Device malfunction
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
General disorders
Device occlusion
|
3.2%
5/155 • Number of events 6 • 5 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Cardiac disorders
Angina pectoris
|
5.8%
9/155 • Number of events 10 • 5 years
|
|
Cardiac disorders
Angina unstable
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Cardiac disorders
Arrhythmia
|
5.2%
8/155 • Number of events 9 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Cardiac disorders
Bradycardia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac arrest
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac failure congestive
|
4.5%
7/155 • Number of events 8 • 5 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
5.8%
9/155 • Number of events 9 • 5 years
|
|
Cardiac disorders
Syncope
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Aorto-oesophageal fistula
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastritis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.5%
7/155 • Number of events 7 • 5 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.65%
1/155 • Number of events 2 • 5 years
|
|
General disorders
Asthenia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
General disorders
Chest pain
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
General disorders
Hernia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
General disorders
Hernia obstructive
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
General disorders
Medical device complication
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
General disorders
Pyrexia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
General disorders
Stent-graft endoleak
|
7.7%
12/155 • Number of events 15 • 5 years
|
|
General disorders
Thrombosis in device
|
15.5%
24/155 • Number of events 36 • 5 years
|
|
General disorders
Unevaluable event
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Infections and infestations
Bacteraemia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Infections and infestations
Bronchitis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Infections and infestations
Cellulitis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Infections and infestations
Clostridial infection
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Infections and infestations
Diverticulitis
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Infections and infestations
Encephalitis viral
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Infections and infestations
Groin abscess
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Infections and infestations
Incision site cellulitis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Infections and infestations
Pneumonia
|
5.2%
8/155 • Number of events 8 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Infections and infestations
Urosepsis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Infections and infestations
Wound infection
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.9%
3/155 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
1.9%
3/155 • Number of events 7 • 5 years
|
|
Injury, poisoning and procedural complications
Vascular injury
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Investigations
Carcinoembryonic antigen increased
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
1.9%
3/155 • Number of events 3 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
1.9%
3/155 • Number of events 3 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal squamous cell carcinoma
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
3.9%
6/155 • Number of events 6 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Nervous system disorders
Carotid artery stenosis
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Nervous system disorders
Cerebral haemorrhage
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Nervous system disorders
Cerebrovascular accident
|
2.6%
4/155 • Number of events 5 • 5 years
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Nervous system disorders
Hemiparesis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Nervous system disorders
Hydrocephalus
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Nervous system disorders
Hypoaesthesia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Nervous system disorders
Multiple sclerosis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Nervous system disorders
Transient ischaemic attack
|
2.6%
4/155 • Number of events 5 • 5 years
|
|
Psychiatric disorders
Confusional state
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Haematuria
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal failure acute
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.5%
7/155 • Number of events 18 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.2%
5/155 • Number of events 5 • 5 years
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Hip arthroplasty
|
1.9%
3/155 • Number of events 3 • 5 years
|
|
Surgical and medical procedures
Intervertebral disc operation
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Intestinal resection
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Large intestine operation
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Vascular disorders
Aneurysm ruptured
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Vascular disorders
Aortic stenosis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Vascular disorders
Arterial stenosis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Vascular disorders
Arteriosclerosis
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
1.9%
3/155 • Number of events 3 • 5 years
|
|
Vascular disorders
Embolism
|
5.8%
9/155 • Number of events 11 • 5 years
|
|
Vascular disorders
Embolism venous
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Vascular disorders
Femoral artery embolism
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Vascular disorders
Haematoma
|
2.6%
4/155 • Number of events 5 • 5 years
|
|
Vascular disorders
Hypertension
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypotension
|
2.6%
4/155 • Number of events 5 • 5 years
|
|
Vascular disorders
Intermittent claudication
|
3.9%
6/155 • Number of events 8 • 5 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.3%
2/155 • Number of events 2 • 5 years
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.65%
1/155 • Number of events 1 • 5 years
|
|
Vascular disorders
Peripheral artery stenosis
|
2.6%
4/155 • Number of events 6 • 5 years
|
|
Vascular disorders
Peripheral artery thrombosis
|
1.3%
2/155 • Number of events 3 • 5 years
|
|
Vascular disorders
Peripheral ischaemia
|
13.5%
21/155 • Number of events 25 • 5 years
|
|
Vascular disorders
Vascular occlusion
|
1.9%
3/155 • Number of events 4 • 5 years
|
|
Vascular disorders
Vascular stenosis
|
2.6%
4/155 • Number of events 6 • 5 years
|
Other adverse events
| Measure |
AAA Repair System
n=155 participants at risk
Aptus Endovascular AAA Repair System: EVAR
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
11/155 • Number of events 11 • 5 years
|
|
Cardiac disorders
Arrhythmia
|
5.8%
9/155 • Number of events 10 • 5 years
|
|
General disorders
Oedema peripheral
|
7.1%
11/155 • Number of events 12 • 5 years
|
|
General disorders
Pyrexia
|
11.0%
17/155 • Number of events 17 • 5 years
|
|
General disorders
Stent-graft endoleak
|
32.9%
51/155 • Number of events 55 • 5 years
|
|
General disorders
Thrombosis in device
|
6.5%
10/155 • Number of events 15 • 5 years
|
|
Infections and infestations
Pneumonia
|
5.2%
8/155 • Number of events 9 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
5.8%
9/155 • Number of events 11 • 5 years
|
|
Renal and urinary disorders
Urinary retention
|
6.5%
10/155 • Number of events 10 • 5 years
|
|
Vascular disorders
Hypertension
|
9.7%
15/155 • Number of events 16 • 5 years
|
|
Vascular disorders
Intermittent claudication
|
14.2%
22/155 • Number of events 24 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place