Trial Outcomes & Findings for Endurant Evo US Clinical Trial (NCT NCT02393716)
NCT ID: NCT02393716
Last Updated: 2022-12-06
Results Overview
The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation. MAEs include the occurrence of any of the following events: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
139 participants
Primary outcome timeframe
30-days
Results posted on
2022-12-06
Participant Flow
Global enrollment was stopped at 139 out of 140 planned. Enrollment start date: 20 April 2015
Participant milestones
| Measure |
Endovascular Repair
Endurant Evo AAA Stent Graft System
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Overall Study
STARTED
|
139
|
|
Overall Study
COMPLETED
|
78
|
|
Overall Study
NOT COMPLETED
|
61
|
Reasons for withdrawal
| Measure |
Endovascular Repair
Endurant Evo AAA Stent Graft System
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Overall Study
Death
|
29
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Device Explanted
|
8
|
|
Overall Study
Missed visit
|
16
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Endovascular Repair
n=139 Participants
Endurant Evo AAA Stent Graft System
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Age, Continuous
|
71.7 years
STANDARD_DEVIATION 7.4 • n=139 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=139 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=139 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=139 Participants
|
|
Region of Enrollment
Europe
|
69 participants
n=139 Participants
|
PRIMARY outcome
Timeframe: 30-daysPopulation: Globally, 4 out 139 Subjects experienced a MAE within 30 days (2.9%).
The percentage of subjects experiencing a Major Adverse Event (MAE) within 30 days post-implantation. MAEs include the occurrence of any of the following events: * All-cause mortality * Bowel ischemia * Myocardial infarction * Paraplegia * Procedural blood loss ≥1000 cc * Renal failure * Respiratory failure * Stroke
Outcome measures
| Measure |
Endovascular Repair
n=139 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
The Percentage of Subjects Experiencing a Major Adverse Event (MAE) Within 30 Days Post-implantation.
|
4 Participants
|
PRIMARY outcome
Timeframe: 12-monthsPopulation: While the full 139 subjects were evaluable for Technical Success at index procedure, 118 subjects were evaluable for treatment success at 12 month follow up.
Successful aneurysm treatment was achieved based on the following criteria: Technical success at the index procedure (as assessed intra-operatively), defined as successful delivery and deployment of the Endurant Evo AAA Stent graft system in the planned location and with no unintentional coverage of both internal iliac arteries or any visceral aortic branches and with successful removal of the delivery system AND Treatment success consisting of freedom from: * AAA diameter increase, defined as \> 5 mm increase in maximum diameter as measured on computed tomography (CT) scan or magnetic resonance angiography/magnetic resonance imaging (MRA/MRI) at 12-month follow-up as compared to 1-month imaging * Types I and III endoleaks at 12-month follow-up including those requiring intervention through 12 months * Aneurysm rupture within 365 days * Conversion to surgery within 365 days * Stent graft migration resulting in a serious adverse event or requiring seco
Outcome measures
| Measure |
Endovascular Repair
n=139 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.
Primary Effectiveness (Technical Success)
|
139 Participants
|
|
The Percentage of Subjects With Both Technical Success at the Time of Index Procedure and Treatment Success at 12-months Post-implantation.
Primary effectiveness (Technical Success and treatment Success)
|
113 Participants
|
SECONDARY outcome
Timeframe: within 30, 183, and 365 daysPopulation: At 0-365 days, 138 subjects were evaluable
All-cause mortality (ACM) within 30, 183, 365 days
Outcome measures
| Measure |
Endovascular Repair
n=139 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
All-cause Mortality
All-Cause Mortality 0-30 Days
|
1 Participants
|
|
All-cause Mortality
All-Cause Mortality 0-183 Days
|
4 Participants
|
|
All-cause Mortality
All-Cause Mortality 0-365 Days
|
8 Participants
|
SECONDARY outcome
Timeframe: within 30, 183, and 365 daysPopulation: In 0-365 days, 133 subjects were evaluable for Aneurysm related mortality
Aneurysm-related mortality (ARM) within 30, 183, and 365 days
Outcome measures
| Measure |
Endovascular Repair
n=139 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Aneurysm-related Mortality (ARM)
Aneurysm-related mortality (ARM) 0-183 days
|
1 Participants
|
|
Aneurysm-related Mortality (ARM)
Aneurysm-related mortality (ARM) 0-30 days
|
1 Participants
|
|
Aneurysm-related Mortality (ARM)
Aneurysm-related mortality (ARM) 0-365 days
|
1 Participants
|
SECONDARY outcome
Timeframe: within 183, and 365 daysPopulation: In 0-183 days, 138 subjects were evaluable In 0-365 days, 132 subjects were evaluable
Any reintervention procedure (surgical or endovascular) following the completion of the operative initial implantation procedure that is used to correct a Type I and III endoleaks within 183 and 365 days. Type I endoleak was defined as a leak resulting from an incomplete seal of the endograft proximally or distally and a Type III endoleak was defined as a leak resulting from a defect of fabric or between the segments of the modular graft (junctional endoleak.
Outcome measures
| Measure |
Endovascular Repair
n=138 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Secondary Procedures to Correct Type I and III Endoleaks
0-183 days
|
0 Participants
|
|
Secondary Procedures to Correct Type I and III Endoleaks
0-365 days
|
1 Participants
|
SECONDARY outcome
Timeframe: within 183, and 365 daysPopulation: In 0-183 days, 138 subjects were evaluable In 0-365 days, 134 subjects were evaluable
Secondary procedures within 183 and 365 days
Outcome measures
| Measure |
Endovascular Repair
n=138 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Secondary Procedures
0-183 days
|
2 Participants
|
|
Secondary Procedures
0-365 days
|
6 Participants
|
SECONDARY outcome
Timeframe: within 30, 183, and 365 daysSerious adverse events within 30, 183 and 365 days.
Outcome measures
| Measure |
Endovascular Repair
n=139 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Serious Adverse Events
0-30 days
|
25 Participants
|
|
Serious Adverse Events
0-183 days
|
48 Participants
|
|
Serious Adverse Events
0-365 days
|
60 Participants
|
SECONDARY outcome
Timeframe: within 183, and 365 daysPopulation: In 0-183 days, 138 subjects were evaluable In 0-365 days, 133 were evaluable
Conversion to open surgery within 183, and 365 days
Outcome measures
| Measure |
Endovascular Repair
n=138 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Conversion to Open Surgery
0-183 days
|
1 Participants
|
|
Conversion to Open Surgery
0-365 days
|
2 Participants
|
SECONDARY outcome
Timeframe: within 183 and 365 daysPopulation: In 0-183 days, 138 subjects were evaluable In 0-365 days, 132 subjects were evaluable
Aneurysm rupture within 183 and 365 days
Outcome measures
| Measure |
Endovascular Repair
n=138 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Aneurysm Rupture
0-183 days
|
0 Participants
|
|
Aneurysm Rupture
0-365 days
|
0 Participants
|
SECONDARY outcome
Timeframe: within 183 and 365 daysPopulation: In 0-183 days, 139 subjects were evaluable In 0-365 days, 138 subjects were evaluable
Major adverse events within 183 and 365 days
Outcome measures
| Measure |
Endovascular Repair
n=139 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Major Adverse Events
0-183 days
|
10 Participants
|
|
Major Adverse Events
0-365 days
|
16 Participants
|
SECONDARY outcome
Timeframe: At 6- and 12-month follow-up visits (as compared to 1-month imaging)Population: At 6-months, 124 subjects were evaluable At 12-months, 121 subjects were evaluable
Stent graft movement of either the main body or iliac limb distally or proximally at 6- and 12-month follow-up visits (as compared to 1-month imaging). Main body stent graft migration is defined as evidence of movement of the main body stent graft relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature. Migration is observed when the stent graft completely covers a renal artery or movement is \> 10 mm either distally or proximally. Stent graft limb/extension migration is defined as evidence of a movement of the stent graft limbs/extensions relative to fixed anatomic landmarks, which is not due to remodeling of the subject's vasculature that is \> 10 mm or coverage of the internal iliac artery.
Outcome measures
| Measure |
Endovascular Repair
n=124 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Stent Graft Migration
6-months
|
1 Participants
|
|
Stent Graft Migration
12-months
|
2 Participants
|
SECONDARY outcome
Timeframe: at 6- and 12-month follow-up visits (as compared to 1-month imaging)Population: At 6-months, 130 subjects were evaluable. At 12-months, 123 subjects were evaluable.
Aneurysm expansion \>5 mm at 6- and 12-month follow-up visits (as compared to 1-month imaging)
Outcome measures
| Measure |
Endovascular Repair
n=130 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Aneurysm Expansion >5 mm
6-months
|
2 Participants
|
|
Aneurysm Expansion >5 mm
12-months
|
2 Participants
|
SECONDARY outcome
Timeframe: at 1-, 6-, and 12-month follow-up visitsPopulation: At 1-month 134, subjects were evaluable. At 6-months, 124 subjects were evaluable. 12-months 117 subjects were evaluable
All endoleaks based on imaging findings at 1-month, 6-month and 12-month. An endoleak is defined by the presence of contrast-enhanced blood outside the lumen of the endoluminal graft but within the aneurysm sac as seen on computed tomography (CT), angiography, ultrasound, or other appropriate imaging modality.
Outcome measures
| Measure |
Endovascular Repair
n=134 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
All Endoleaks Based on Imaging Findings
1-month. Participants with any type of endoleak
|
45 Participants
|
|
All Endoleaks Based on Imaging Findings
6-months. Participants with any type of endoleak
|
29 Participants
|
|
All Endoleaks Based on Imaging Findings
12-months. Participants with any type of endoleak
|
29 Participants
|
SECONDARY outcome
Timeframe: Through 1-, 6- and 12 monthsPopulation: Through 1-month, 136 subjects were evaluable. Through 6-months, 124 subjects were evaluable. Through 12-months, 120 subjects were evaluable.
Stent graft occlusions based on imaging findings through 1-, 6- and 12 months. Stent graft occlusion is defined as a 100% blockage of the lumen diameter of any implanted stent graft component(s) as evidenced by CT, angiography, ultrasound, or other appropriate imaging modality, and/or operative or pathological analysis.
Outcome measures
| Measure |
Endovascular Repair
n=136 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Stent Graft Occlusions Based on Imaging Findings
1-month
|
0 Participants
|
|
Stent Graft Occlusions Based on Imaging Findings
6-months
|
1 Participants
|
|
Stent Graft Occlusions Based on Imaging Findings
12-months
|
1 Participants
|
SECONDARY outcome
Timeframe: Through 6- and 12 monthsPopulation: Through 6-months, 125 subjects were evaluable. Through 12-months, 126 subjects were evaluable.
Device deficiencies based on imaging findings through 6- and 12 months. A device deficiency was defined according Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance (ref. ISO 14155:2011 3.15).
Outcome measures
| Measure |
Endovascular Repair
n=126 Participants
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Device Deficiencies Based on Imaging Findings
6-months. Any device deficiency.
|
27 Participants
|
|
Device Deficiencies Based on Imaging Findings
12-months. Any device deficiency.
|
41 Participants
|
Adverse Events
Endovascular Repair
Serious events: 105 serious events
Other events: 38 other events
Deaths: 29 deaths
Serious adverse events
| Measure |
Endovascular Repair
n=139 participants at risk
Endurant Evo AAA Stent Graft System
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Blood and lymphatic system disorders
Heparin induced thrombocytopenia
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Blood and lymphatic system disorders
Pancytopenia
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
5.0%
7/139 • Number of events 7 • 60-month
|
|
Cardiac disorders
ANGINA PECTORIS
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
Cardiac disorders
ANGINA UNSTABLE
|
2.2%
3/139 • Number of events 4 • 60-month
|
|
Cardiac disorders
AORTIC VALVE STENOSIS
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
5.0%
7/139 • Number of events 9 • 60-month
|
|
Cardiac disorders
BRADYCARDIA
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Cardiac disorders
CARDIAC ARREST
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
3.6%
5/139 • Number of events 9 • 60-month
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Cardiac disorders
ISCHAEMIC CARDIOMYOPATHY
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Congenital, familial and genetic disorders
HYDROCELE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Eye disorders
CATARACT
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
ASCITES
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
COLITIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
COLITIS ULCERATIVE
|
0.72%
1/139 • Number of events 2 • 60-month
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
ENTEROCOLITIS HAEMORRHAGIC
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
1.4%
2/139 • Number of events 3 • 60-month
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
INTESTINAL ISCHAEMIA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
INTESTINAL POLYP
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
LOCALISED INTRAABDOMINAL FLUID COLLECTION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
MELAENA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
NAUSEA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
SMALL INTESTINAL HAEMORRHAGE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Gastrointestinal disorders
VOMITING
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
General disorders
ASTHENIA
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
General disorders
CHEST PAIN
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
General disorders
DEATH
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
General disorders
DEVICE DAMAGE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
General disorders
DEVICE DISLOCATION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
General disorders
IMPAIRED HEALING
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
General disorders
MALAISE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
General disorders
PYREXIA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
General disorders
STENT-GRAFT ENDOLEAK
|
11.5%
16/139 • Number of events 18 • 60-month
|
|
General disorders
THROMBOSIS IN DEVICE
|
2.2%
3/139 • Number of events 5 • 60-month
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Hepatobiliary disorders
JAUNDICE CHOLESTATIC
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Infections and infestations
BACTERIAL INFECTION
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Infections and infestations
GROIN INFECTION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Infections and infestations
HERPES ZOSTER
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Infections and infestations
INFECTION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Infections and infestations
INFECTIVE ANEURYSM
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Infections and infestations
INFLUENZA
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Infections and infestations
LOCALISED INFECTION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Infections and infestations
PNEUMONIA
|
7.9%
11/139 • Number of events 11 • 60-month
|
|
Infections and infestations
PNEUMONIA LEGIONELLA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Infections and infestations
POSTOPERATIVE ABSCESS
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Infections and infestations
SEPSIS
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Infections and infestations
SEPTIC SHOCK
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Infections and infestations
URINARY TRACT INFECTION
|
5.0%
7/139 • Number of events 7 • 60-month
|
|
Infections and infestations
UROSEPSIS
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Infections and infestations
VIRAL PHARYNGITIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Infections and infestations
WOUND INFECTION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
CARBON MONOXIDE POISONING
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
FRACTURED SACRUM
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.72%
1/139 • Number of events 2 • 60-month
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
PERIPHERAL ARTERY RESTENOSIS
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMORRHAGE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Injury, poisoning and procedural complications
WOUND
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Investigations
HAEMATOCRIT DECREASED
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Metabolism and nutrition disorders
PROPOFOL INFUSION SYNDROME
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-HODGKIN'S LYMPHOMA RECURRENT
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE LEUKAEMIA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON ADENOMA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATOCELLULAR CARCINOMA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT NEOPLASM OF RENAL PELVIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC SQUAMOUS CELL CARCINOMA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MYELOFIBROSIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NASAL NEOPLASM BENIGN
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER RECURRENT
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA METASTATIC
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER METASTATIC
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECURRENT CANCER
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CARCINOMA
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Nervous system disorders
CAROTID ARTERIOSCLEROSIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
Nervous system disorders
DIZZINESS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Nervous system disorders
NEUROLOGICAL SYMPTOM
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Nervous system disorders
NEUROTOXICITY
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Nervous system disorders
PARKINSON'S DISEASE
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
Nervous system disorders
PETIT MAL EPILEPSY
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Nervous system disorders
SYNCOPE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Psychiatric disorders
ANXIETY
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Nervous system disorders
CONFUSIONAL STATE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Nervous system disorders
DEPRESSION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
2.9%
4/139 • Number of events 5 • 60-month
|
|
Renal and urinary disorders
URINARY RETENTION
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
2.9%
4/139 • Number of events 4 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
3.6%
5/139 • Number of events 7 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL HYPERTROPHY
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.72%
1/139 • Number of events 2 • 60-month
|
|
Reproductive system and breast disorders
PULMONARY OEDEMA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ACIDOSIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
Surgical and medical procedures
ABDOMINAL HERNIA REPAIR
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Surgical and medical procedures
HIP ARTHROPLASTY
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Vascular disorders
ANEURYSM
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Vascular disorders
AORTIC ANEURYSM RUPTURE
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
Vascular disorders
AORTIC THROMBOSIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Vascular disorders
HAEMORRHAGE
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Vascular disorders
HYPERTENSION
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Vascular disorders
HYPOTENSION
|
2.2%
3/139 • Number of events 3 • 60-month
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Vascular disorders
PERIPHERAL ARTERY ANEURYSM
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Vascular disorders
PERIPHERAL ARTERY STENOSIS
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Vascular disorders
PERIPHERAL ARTERY THROMBOSIS
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.72%
1/139 • Number of events 1 • 60-month
|
|
Vascular disorders
THROMBOSIS
|
1.4%
2/139 • Number of events 2 • 60-month
|
|
Vascular disorders
VASCULAR STENOSIS
|
0.72%
1/139 • Number of events 1 • 60-month
|
Other adverse events
| Measure |
Endovascular Repair
n=139 participants at risk
Endurant Evo AAA Stent Graft System
Endurant Evo AAA Stent Graft System
Endovascular aneurysm repair (EVAR)
|
|---|---|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.0%
7/139 • Number of events 7 • 60-month
|
|
General disorders
FATIGUE
|
6.5%
9/139 • Number of events 9 • 60-month
|
|
General disorders
PYREXIA
|
5.0%
7/139 • Number of events 7 • 60-month
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.5%
9/139 • Number of events 9 • 60-month
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
5.8%
8/139 • Number of events 8 • 60-month
|
|
Vascular disorders
HAEMATOMA
|
5.8%
8/139 • Number of events 10 • 60-month
|
|
Vascular disorders
HYPOTENSION
|
5.0%
7/139 • Number of events 7 • 60-month
|
Additional Information
Kristel Wittebols Sr. Clinical Research Director
Medtronic
Phone: 31 (0)43-3566566
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place