Trial Outcomes & Findings for Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms (NCT NCT02489539)
NCT ID: NCT02489539
Last Updated: 2025-08-13
Results Overview
The primary safety endpoint event includes a composite of the following: * Death * Stroke * Myocardial Infarction * Bowel Ischemia * Paraplegia * Respiratory Failure * Renal Failure * Procedural Blood Loss \> 1000 mL * Thromboembolic events (including limb occlusion and distal embolic events)
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
30 Days
Results posted on
2025-08-13
Participant Flow
Participant milestones
| Measure |
Short Neck Substudy
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
High Neck Angulation Substudy
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
95
|
|
Overall Study
COMPLETED
|
78
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
95
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
Baseline characteristics by cohort
| Measure |
Short Neck Substudy
n=80 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
High Neck Angulation Substudy
n=95 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
Total
n=175 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73 years
n=99 Participants
|
74 years
n=107 Participants
|
74 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=99 Participants
|
71 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
75 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
162 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=99 Participants
|
95 participants
n=107 Participants
|
175 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 DaysPopulation: This population consists of subjects with a physical exam follow-up visit at or after 30 days following CEXC device implant procedure. Additionally, any subjects with an eligible safety event, even if they did not complete a follow-up visit at or after 30 days following implant procedure, were included.
The primary safety endpoint event includes a composite of the following: * Death * Stroke * Myocardial Infarction * Bowel Ischemia * Paraplegia * Respiratory Failure * Renal Failure * Procedural Blood Loss \> 1000 mL * Thromboembolic events (including limb occlusion and distal embolic events)
Outcome measures
| Measure |
Short Neck Substudy
n=79 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
High Neck Angulation Substudy
n=92 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
|---|---|---|
|
Number of Subjects Free From Primary Safety Endpoint Event
|
79 Participants
|
89 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: This population consists of subjects with both a post-op contrast-enhanced CT (CTA) and a 12-Month CTA. Additionally, any subjects with an eligible effectiveness event, even if they did not complete the necessary follow-up visit or imaging to otherwise be included in the population, were included.
The Primary Effectiveness Endpoint of device treatment success is a composite of technical success (successful access and deployment of all required GORE® EXCLUDER® Conformable AAA Endoprosthesis components) and freedom from: * Type I endoleak in the 12 month window * Type III endoleak in the 12 month window * Migration (10 mm or more) at the 12 month window (relative to post-operative baseline) * AAA enlargement ≥5 mm with or without intervention at the 12 month window (relative to post-operative baseline) * AAA rupture through the 12 month window * Conversion to open repair through the 12 month window
Outcome measures
| Measure |
Short Neck Substudy
n=66 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
High Neck Angulation Substudy
n=77 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
|---|---|---|
|
Number of Subjects With Device Treatment Success
|
65 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: 5 yearsDefined as an adverse event treatment performed to either treat the abdominal aneurysm and/or device-related complication (Adjudicated by independent Clinical Events Committee)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as fracture of the wire used to construct the stent (assessed by independent 3rd party imaging laboratory)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as an endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch. (assessed by independent 3rd party imaging laboratory)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as a composite of the following: death within 30 days or in hospital from initial procedure, death due to rupture of the originally treated aneurysm and death within 30 days or in hospital following a procedure to treat the originally treated aneurysm. (Adjudicated by independent Clinical Events Committee)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Procedure DayPopulation: Subjects with non-missing procedural blood loss
Defined as estimated blood loss recorded during the endovascular procedure \> 1000 mL
Outcome measures
| Measure |
Short Neck Substudy
n=80 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
High Neck Angulation Substudy
n=93 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
|---|---|---|
|
Number of Subjects With Significant Index Procedure Blood Loss
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 5 yearsDefined as Endoleak of whole blood through the graft fabric (Graft Porosity). (assessed by independent 3rd party imaging laboratory)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through initial hospital dischargePopulation: All enrolled subjects
Defined as time to discharge for initial procedural hospitalization
Outcome measures
| Measure |
Short Neck Substudy
n=80 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
High Neck Angulation Substudy
n=95 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
|---|---|---|
|
Median Hospital Stay
|
1.0 days
Interval 1.0 to 4.0
|
1.0 days
Interval 1.0 to 13.0
|
SECONDARY outcome
Timeframe: Procedure DayPopulation: All enrolled subjects
Defined as time from first arterial access in the groin to the closure of the final access vessel
Outcome measures
| Measure |
Short Neck Substudy
n=80 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
High Neck Angulation Substudy
n=95 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
|---|---|---|
|
Median Index Procedure Time
|
84.0 minutes
Interval 33.0 to 251.0
|
110 minutes
Interval 40.0 to 358.0
|
SECONDARY outcome
Timeframe: 5 yearsDefined as stroke resulting in severe impairment or fatal outcome (Adjudicated by independent Clinical Events Committee)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as myocardial Infarction resulting in severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome. (Adjudicated by independent Clinical Events Committee)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as bowel Ischemia resulting in bowel resection or fatal outcome (Adjudicated by independent Clinical Events Committee)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsParaplegia resulting in major permanent deficit (Adjudicated by independent Clinical Events Committee)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as death of any cause (all-cause mortality)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as renal failure resulting in permanent dialysis, transplant, or fatal outcome (Adjudicated by independent Clinical Events Committee)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as respiratory failure resulting in prolonged intubation (\> 48 hours), tracheostomy, deterioration in pulmonary function, new onset O2 dependence, or fatal outcome (Adjudicated by independent Clinical Events Committee)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as ischemic events from tissues distal to the device implantation site (lower extremity, buttock, etc.) and that are a direct result of an occlusion within the device or sufficiently debilitating to necessitate bypass, open surgical repair, or limb amputation (Adjudicated by independent Clinical Events Committee)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as endoleak arising from the proximal (Type IA) or distal (Type IB) sealing zone of the device perfusing the aneurysm. (assessed by independent 3rd party imaging laboratory)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as endoleak arising from the component junction(s) of the prosthesis or due to damage to the graft material (assessed by independent 3rd party imaging laboratory)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as prosthesis and/or intercomponent migration (10 mm or more) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Procedure DayPopulation: Number of subjects with non-missing blood loss
Median blood loss at index procedure
Outcome measures
| Measure |
Short Neck Substudy
n=80 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
High Neck Angulation Substudy
n=93 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
|---|---|---|
|
Median Procedural Blood Loss (mL)
|
50 mL
Interval 0.0 to 1000.0
|
50 mL
Interval 0.0 to 2700.0
|
SECONDARY outcome
Timeframe: 5 yearsDefined as AAA enlargement ≥5 mm (with or without reintervention) relative to post-operative baseline (assessed by independent 3rd party imaging laboratory)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as rupture in the treated segment of the aorta verified with direct observation or CT scan
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsDefined as open surgical abdominal aneurysm repair necessitating the explant of the stent-graft and abdominal aortic reconstruction (Adjudicated by independent Clinical Events Committee)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Procedure DayPopulation: All enrolled subjects
Successful access and deployment of all required CEXC device components, comprised of all the following: * Successful access * Successful deployment of Device endoprostheses in the intended anatomical location * Successful removal of all device delivery catheters from the patient * Patent Device components on completion angiography * Absence of Type I or Type III endoleak on completion angiography * Successful access site closure
Outcome measures
| Measure |
Short Neck Substudy
n=80 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
High Neck Angulation Substudy
n=95 Participants
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
|---|---|---|
|
Technical Success
|
80 Participants
|
93 Participants
|
Adverse Events
Short Neck Substudy
Serious events: 48 serious events
Other events: 32 other events
Deaths: 15 deaths
High Neck Angulation Substudy
Serious events: 57 serious events
Other events: 48 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Short Neck Substudy
n=80 participants at risk
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
High Neck Angulation Substudy
n=95 participants at risk
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
|---|---|---|
|
Infections and infestations
Pyelonephritis
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Infections and infestations
Recurrent urinary tract infection
|
1.2%
1/80 • Number of events 2 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Infections and infestations
Sepsis
|
3.8%
3/80 • Number of events 3 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Septic pulmonary embolism
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Acute anemia
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
6.3%
6/95 • Number of events 6 • Up to 5 years
|
|
Blood and lymphatic system disorders
Symptomatic anemia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Acute decompensated heart failure
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Atrial flutter
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/80 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
Cardiac arrhythmia
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Cardiac disorders
Cardiac failure aggravated
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Cardiomyopathy
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Cardiac disorders
Cardiopulmonary failure
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Chest pain - cardiac
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Cardiac disorders
Chronic diastolic heart failure
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
Chronic heart failure
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Cardiac disorders
Congestive cardiac failure aggravated
|
0.00%
0/80 • Up to 5 years
|
3.2%
3/95 • Number of events 3 • Up to 5 years
|
|
Cardiac disorders
Congestive heart failure
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
Coronary artery disease
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Coronary artery disease aggravated
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Cardiac disorders
Heart attack
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Heart block third degree
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Cardiac disorders
Junctional bradycardia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Left anterior fascicular block
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Mitral regurgitation
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Non STEMI
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Cardiac disorders
Non-sustained ventricular tachycardia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Persistent atrial fibrillation
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Cardiac disorders
Right bundle branch block
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Stress cardiomyopathy
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Acute diarrhea
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Acute pancreatitis
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Gastrointestinal disorders
Ascites
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Gastrointestinal disorders
Bowel obstruction
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Colovesical fistula
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Gastrointestinal disorders
Distress gastrointestinal
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Gastrointestinal disorders
Enterocolitis
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/80 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Gastritis erosive
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Gastrointestinal disorders
Lower gastrointestinal bleeding
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Gastrointestinal disorders
Mouth bleeding
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/80 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Gastrointestinal disorders
Pancreatitis acute on chronic
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Rectal bleeding
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Gastrointestinal disorders
Small bowel obstruction
|
2.5%
2/80 • Number of events 3 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
General disorders
Edema of lower extremities
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
General disorders
Endotension
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
General disorders
General debility
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
General disorders
Incarcerated hernia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
General disorders
Stent-graft endoleak type IA
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
General disorders
Stent-graft endoleak type IB
|
0.00%
0/80 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
General disorders
Stent-graft endoleak type II
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
4.2%
4/95 • Number of events 5 • Up to 5 years
|
|
General disorders
Unknown cause of death
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
4.2%
4/95 • Number of events 4 • Up to 5 years
|
|
General disorders
Weakness generalized
|
3.8%
3/80 • Number of events 3 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Hepatobiliary disorders
Liver cirrhosis
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Hepatobiliary disorders
Mirizzi syndrome
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Aspiration pneumonia
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Infections and infestations
Bloodstream infection
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Infections and infestations
Bronchitis
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Infections and infestations
COVID-19
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/80 • Up to 5 years
|
3.2%
3/95 • Number of events 3 • Up to 5 years
|
|
Infections and infestations
Cellulitis
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Cellulitis of leg
|
0.00%
0/80 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Clostridium difficile colitis
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Infections and infestations
Community acquired pneumonia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Device related infection
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Influenza A virus infection
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Klebsiella pneumonia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Pneumonia
|
6.2%
5/80 • Number of events 5 • Up to 5 years
|
5.3%
5/95 • Number of events 7 • Up to 5 years
|
|
Infections and infestations
Septic shock
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
3.2%
3/95 • Number of events 3 • Up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
5.0%
4/80 • Number of events 4 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Urinary tract infection bacterial
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Infections and infestations
Urosepsis
|
1.2%
1/80 • Number of events 2 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/80 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Femoral artery pseudoaneurysm
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fractured ribs
|
1.2%
1/80 • Number of events 2 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Incision site ecchymosis
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Injury to iliac artery
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Lumbar spine compression fracture
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Thoracic spine compression fracture
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture T9
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Traumatic hemothorax
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Investigations
Elevated prostate specific antigen [PSA]
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/80 • Up to 5 years
|
3.2%
3/95 • Number of events 3 • Up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall hematoma
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Degenerative joint disease
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Hip arthritis
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Hips osteoarthritis
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix cancer
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenomatous polyp
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial carcinoma recurrent
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liver metastases
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
3.8%
3/80 • Number of events 3 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung metastases
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of descending colon
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic colon cancer
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric adenocarcinoma
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm of liver
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm urinary bladder
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progression of prostate cancer
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal metastases
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Unknown primary cancer
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Nervous system disorders
Alzheimer's disease
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
Internal carotid artery stenosis
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Lightheadedness
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Nervous system disorders
Memory loss
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Metabolic encephalopathy
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Nervous system disorders
Middle cerebral artery stroke
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Nervous system disorders
Stroke
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/80 • Up to 5 years
|
3.2%
3/95 • Number of events 3 • Up to 5 years
|
|
Nervous system disorders
Transient ischemic attack
|
1.2%
1/80 • Number of events 2 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Nervous system disorders
VIth nerve palsy
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 2 • Up to 5 years
|
|
Product Issues
Device kink
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
Mental status changes
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/80 • Up to 5 years
|
3.2%
3/95 • Number of events 3 • Up to 5 years
|
|
Renal and urinary disorders
Acute renal failure
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Acute renal insufficiency
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Renal and urinary disorders
Chronic renal insufficiency
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
End stage renal disease (ESRD)
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Hematuria
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Renal and urinary disorders
Impaired renal function
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Renal artery dissection
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Renal and urinary disorders
Renal artery occlusion
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxic respiratory failure
|
0.00%
0/80 • Up to 5 years
|
3.2%
3/95 • Number of events 5 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute on chronic respiratory failure
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
3.2%
3/95 • Number of events 3 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonitis
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease exacerbation
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
4.2%
4/95 • Number of events 5 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea exacerbated
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
0.00%
0/80 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/80 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/80 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolus
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hemorrhage
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Unilateral pleural effusion
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Venous stasis ulcer
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Surgical and medical procedures
Pacemaker battery replacement
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Arterial bleeding
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Deep vein thrombosis leg
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/80 • Up to 5 years
|
2.1%
2/95 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Lower limb ischemia
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Lymphedema
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
|
Vascular disorders
Popliteal artery aneurysm
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Vascular disorders
Popliteal artery occlusion
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Vascular disorders
Refractory shock
|
1.2%
1/80 • Number of events 1 • Up to 5 years
|
0.00%
0/95 • Up to 5 years
|
|
Vascular disorders
Type A aortic dissection
|
0.00%
0/80 • Up to 5 years
|
1.1%
1/95 • Number of events 1 • Up to 5 years
|
Other adverse events
| Measure |
Short Neck Substudy
n=80 participants at risk
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation ≤ 60˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
High Neck Angulation Substudy
n=95 participants at risk
Subjects with abdominal aortic aneurysms having infrarenal aortic neck angulation \> 60˚ and ≤ 90˚ and infrarenal aortic neck length ≥10 mm treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis.
|
|---|---|---|
|
General disorders
Stent-graft endoleak type II
|
40.0%
32/80 • Number of events 38 • Up to 5 years
|
46.3%
44/95 • Number of events 46 • Up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
2.5%
2/80 • Number of events 2 • Up to 5 years
|
8.4%
8/95 • Number of events 8 • Up to 5 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/80 • Up to 5 years
|
5.3%
5/95 • Number of events 5 • Up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI(s) are restricted publishing multi-site aggregate trial results until the multi-center manuscript is published (Gore reserves the right to extend (as applicable) if filing a patent application). Prior to publication, Gore is allowed 60 day review period and the right to remove proprietary information.
- Publication restrictions are in place
Restriction type: OTHER