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Valiant Evo US Clinical Trial (VEVO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02652949
Recruitment Status : Active, not recruiting
First Posted : January 12, 2016
Results First Posted : February 26, 2019
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aortic Aneurysm, Thoracic
Intervention Device: Valiant Evo Thoracic Stent Graft System
Enrollment 100
Recruitment Details 100 subjects (53 US, 47 Outside US [OUS]), from 18 US sites and 15 OUS sites, contributed to the global cohort. The 1st subject was enrolled on 25/APRIL/2016, the 100th subject on 28/MARCH/2018.
Pre-assignment Details A total of 152 subjects were consented to be reviewed for enrollment. 52 subjects were not approved for implantation, 100 subjects were approved for implantation. The 30-day primary endpoint was evaluated when 87 subjects completed 30-day follow-up.
Arm/Group Title Endovascular Repair
Hide Arm/Group Description Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysms (DTAA) and who met the inclusion and exclusion criteria.
Period Title: 30-Day Follow-up for Primary Endpoint
Started 87 [1]
Completed 86
Not Completed 1
Reason Not Completed
Death             1
[1]
The 30-day primary endpoint was evaluated when 87 subjects completed 30-day follow-up.
Period Title: 30-Day Follow-up for Secondary Endpoint
Started 100 [1]
Completed 99
Not Completed 1
Reason Not Completed
Death             1
[1]
The 30-day secondary endpoint was evaluated when 100 subjects completed 30-day follow-up.
Period Title: 6-Month Follow-up Secondary Endpoint
Started 99 [1]
Completed 91
Not Completed 8
Reason Not Completed
Death             5
Withdrawal by Subject             2
Lost to Follow-up             1
[1]
Note that 6-month follow up is not mandatory for OUS subjects.
Period Title: 12-Month Follow-up Secondary Endpoint
Started 91
Completed 87
Not Completed 4
Reason Not Completed
Death             4
Period Title: 24-Month Follow-up Secondary Endpoint
Started 87
Completed 52
Not Completed 35
Reason Not Completed
Death             2
Withdrawal by Subject             3
Lost to Follow-up             2
Subject declined reconsenting to extended follow-up out to 5 years             28
Arm/Group Title Endovascular Repair
Hide Arm/Group Description Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm (DTAA) and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]).
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
70.8  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
40
  40.0%
Male
60
  60.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed Number Analyzed 53 participants
White
42
  79.2%
Non-White
11
  20.8%
[1]
Measure Analysis Population Description: Race data were not collected in OUS per regulation
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants
53
Canada Number Analyzed 100 participants
7
Denmark Number Analyzed 100 participants
1
Netherlands Number Analyzed 100 participants
4
United Kingdom Number Analyzed 100 participants
8
Italy Number Analyzed 100 participants
17
France Number Analyzed 100 participants
10
1.Primary Outcome
Title Composite Safety and Effectiveness Endpoint That is Based on the Percentage of Subjects Who Experienced (a) Access and/or Deployment Failures; and/or (b) Major Device Effect (MDE) Within 30 Days Post Index Procedure
Hide Description

MDEs include: device-related secondary procedures, device-related mortality, conversion to open surgery, thoracic aortic aneurysm rupture.

Access failure: Inability to insert device due to mechanical failure or anatomic exclusions of the femoral or iliac arteries.

Deployment failure: Deployment failure due to subject anatomy or mechanical failure. Specifically, deployment of the stent graft from the delivery system.

Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects. The poolability on the primary endpoint between US and OUS data were assessed using Fisher's exact test.

Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The 30-day primary endpoint was evaluated for PMA approval when 87 subjects completed 30 day follow-up.
Arm/Group Title Endovascular Repair
Hide Arm/Group Description:

Valiant Evo Thoracic Stent Graft System: Procedure: thoracic endovascular aneurysm repair (TEVAR).

Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the primary endpoint global cohort of 87 subjects (52 US, 35 OUS).

Overall Number of Participants Analyzed 87
Measure Type: Count of Participants
Unit of Measure: Participants
2
   2.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Endovascular Repair
Comments

The primary study endpoint, major device effect at 30 days, is a dichotomous study outcome; hence, an exact method based on the binomial distribution was used for the hypothesis testing. The primary study endpoint was tested against a performance goal of 16%:

H0: p ≥ 16% vs. Ha: p <16%, where p denotes the true event rate of primary study endpoint in the target population.

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Exact binomial test
Comments [Not Specified]
Method of Estimation Estimation Parameter Event rate
Estimated Value 0.023
Confidence Interval (1-Sided) 97.5%
0.081
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Safety and Effectiveness Outcome
Hide Description

Safety and Effectiveness outcome measures between 0-30 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US [OUS]).

Measures include: peri-operative mortality, adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, and endoleaks.

Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Arm/Group Title Endovascular Repair
Hide Arm/Group Description:
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
Peri-Operative Mortality Number Analyzed 100 participants
2
   2.0%
Adverse Events (AE) Number Analyzed 100 participants
72
  72.0%
Major Adverse Events (MAE) Number Analyzed 100 participants
29
  29.0%
Serious Adverse Events (SAE) Number Analyzed 100 participants
32
  32.0%
Secondary Procedures Number Analyzed 100 participants
2
   2.0%
Loss of Stent Graft Patency Number Analyzed 95 participants
0
   0.0%
Endoleaks Number Analyzed 94 participants
4
   4.3%
3.Secondary Outcome
Title Safety and Effectiveness Outcome
Hide Description

Safety outcome measures between 0-183 days and Effectiveness outcome measures between 31-183 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.

Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.

Time Frame 6 month
Hide Outcome Measure Data
Hide Analysis Population Description

Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International Trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US).

Note that 6-month follow up is not mandatory for subjects enrolled under the Valiant Evo International protocol, resulting in fewer subjects analyzed at 6 months.

Arm/Group Title Endovascular Repair
Hide Arm/Group Description:
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 Outside US).
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
All-Cause Mortality (ACM) Number Analyzed 99 participants
6
   6.1%
Aneurysm-Related Mortality (ARM) Number Analyzed 97 participants
3
   3.1%
Major Device Effects (MDE) Number Analyzed 96 participants
2
   2.1%
Adverse Events (AE) Number Analyzed 100 participants
80
  80.0%
Major Adverse Events (MAE) Number Analyzed 100 participants
39
  39.0%
Serious Adverse Events (SAE) Number Analyzed 100 participants
50
  50.0%
Secondary Procedures Number Analyzed 96 participants
4
   4.2%
Loss of Stent Graft Patency Number Analyzed 53 participants
0
   0.0%
Endoleaks Number Analyzed 52 participants
4
   7.7%
Stent Graft Migration Number Analyzed 55 participants
0
   0.0%
Aneurysm Expansion >5 mm relative to 1-Month Number Analyzed 54 participants
1
   1.9%
4.Secondary Outcome
Title Safety and Effectiveness Outcome
Hide Description

Safety outcome measures between 0-365 days and Effectiveness outcome measures between 184-365 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.

Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.

Time Frame 12 Month
Hide Outcome Measure Data
Hide Analysis Population Description
Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Arm/Group Title Endovascular Repair
Hide Arm/Group Description:
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
All-Cause Mortality (ARM) Number Analyzed 97 participants
10
  10.3%
Aneurysm-Related Mortality (ARM) Number Analyzed 90 participants
3
   3.3%
Major Device Effects (MDE) Number Analyzed 90 participants
4
   4.4%
Adverse Events (AE) Number Analyzed 100 participants
82
  82.0%
Major Adverse Events (MAE) Number Analyzed 100 participants
44
  44.0%
Serious Adverse Events (SAE) Number Analyzed 100 participants
54
  54.0%
Secondary Procedures Number Analyzed 89 participants
5
   5.6%
Loss of Stent Graft Patency Number Analyzed 78 participants
0
   0.0%
Endoleaks Number Analyzed 76 participants
5
   6.6%
Stent Graft Migration Number Analyzed 77 participants
0
   0.0%
Aneurysm Expansion >5 mm relative to 1-Month Number Analyzed 76 participants
3
   3.9%
5.Secondary Outcome
Title Safety and Effectiveness Outcome
Hide Description

Safety outcome measures between 0-730 days and Effectiveness outcome measures between 366-730 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.

Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.

Time Frame 24 Month
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysm and who met the inclusion and exclusion criteria. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort of 100 subjects (53 US, 47 OUS).
Arm/Group Title Endovascular Repair
Hide Arm/Group Description:
Subjects who were appropriate candidates for endovascular repair of Descending Thoracic Aortic Aneurysms (DTAA) and who met the inclusion and exclusion criteria.
Overall Number of Participants Analyzed 100
Measure Type: Count of Participants
Unit of Measure: Participants
All-Cause Mortality (ACM) Number Analyzed 66 participants
13
  19.7%
Aneurysm-Related Mortality (ARM) Number Analyzed 58 participants
3
   5.2%
Major Device Effects (MDE) Number Analyzed 59 participants
5
   8.5%
Adverse Events (AE) Number Analyzed 96 participants
85
  88.5%
Major Adverse Event (MAE) Number Analyzed 96 participants
49
  51.0%
Serious Adverse Event (SAE) Number Analyzed 96 participants
60
  62.5%
Secondary Procedures Number Analyzed 58 participants
6
  10.3%
Loss of Stent Graft Patency Number Analyzed 48 participants
0
   0.0%
Endoleaks Number Analyzed 45 participants
2
   4.4%
Stent Graft Migration Number Analyzed 46 participants
0
   0.0%
Aneurysm Expansion >5 mm relative to 1-Month Number Analyzed 48 participants
3
   6.3%
6.Secondary Outcome
Title Safety and Effectiveness Outcome
Hide Description

Safety outcome measures between 0-1095 days and Effectiveness outcome measures between 731-1095 days post implant procedure. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.

Safety measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE) and secondary procedures. Effectiveness measures include loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.

Time Frame 36 Month
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Safety and Effectiveness Outcome
Hide Description

Safety and Effectiveness outcome measures between implant procedure and 48 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.

Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.

Time Frame 48 Month
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Safety and Effectiveness Outcome
Hide Description

Safety and Effectiveness outcome measures between implant procedure and 60 months. Data from the Valiant Evo US trial (NCT02652949) and Valiant Evo International trial (NCT02625324) were combined to create the global cohort.

Measures include: all-cause mortality (ACM), aneurysm related mortality (ARM), major device effects (MDE), adverse events (AE), major adverse events (MAE), serious adverse events (SAE), secondary procedures, loss of stent graft patency, endoleaks, stent graft migration as compared to 1-month, and aneurysm expansion greater than 5 mm as compared to 1-month.

Time Frame 60 Month
Outcome Measure Data Not Reported
Time Frame Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months and 24 Months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Endovascular Repair 30-Day Secondary Endpoint Endovascular Repair 6-Month Secondary Endpoint Endovascular Repair 12-Month Secondary Endpoint Endovascular Repair 24-Month Secondary Endpoint
Hide Arm/Group Description

Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality, or one or more serious adverse event within 0-30 days Procedure: thoracic endovascular aneurysm repair (TEVAR)

For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 30-Day time period or were followed for at least 1 day.

For Adverse Events, the 30-Day time period for reporting is 0-30 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 30-Day time interval.

Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-183 days, or one or more serious adverse event within 31-183 days Procedure: thoracic endovascular aneurysm repair (TEVAR)

For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 6-Month time period or were followed for at least 91 days.

For Adverse Events, the 6-Month time period for reporting is 31-183 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 6-Month time interval.

Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-365 days, or one or more serious adverse event within 184-365 days Procedure: thoracic endovascular aneurysm repair (TEVAR)

For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 12-Month time period or were followed for at least 305 days.

For Adverse Events, the 12-Month time period for reporting is 184-365 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 12-Month time interval.

Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-730 days, or one or more serious adverse event within 366-730 days Procedure: thoracic endovascular aneurysm repair (TEVAR)

For All-Cause Mortality, the number of participants at risk includes all enrolled subjects who either had an event within the 24-Month time period or were followed for at least 549 days.

For Adverse Events, the 24-Month time period for reporting is 366-730 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 24-Month time interval.

All-Cause Mortality
Endovascular Repair 30-Day Secondary Endpoint Endovascular Repair 6-Month Secondary Endpoint Endovascular Repair 12-Month Secondary Endpoint Endovascular Repair 24-Month Secondary Endpoint
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/100 (2.00%)   6/99 (6.06%)   10/97 (10.31%)   13/66 (19.70%) 
Hide Serious Adverse Events
Endovascular Repair 30-Day Secondary Endpoint Endovascular Repair 6-Month Secondary Endpoint Endovascular Repair 12-Month Secondary Endpoint Endovascular Repair 24-Month Secondary Endpoint
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/100 (32.00%)   27/98 (27.55%)   21/91 (23.08%)   17/80 (21.25%) 
Blood and lymphatic system disorders         
Anaemia  1  0/100 (0.00%)  2/98 (2.04%)  0/91 (0.00%)  0/80 (0.00%) 
Anaemia of Chronic Disease  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Blood Loss Anaemia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Neutrophilia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Splenic Lesion  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Cardiac disorders         
Acute Myocardial Infarction  1  1/100 (1.00%)  0/98 (0.00%)  1/91 (1.10%)  2/80 (2.50%) 
Angina Unstable  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Atrial Fibrillation  1  3/100 (3.00%)  2/98 (2.04%)  1/91 (1.10%)  1/80 (1.25%) 
Atrioventricular Block  1  1/100 (1.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Cardiac Failure  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Cardiac Failure Congestive  1  2/100 (2.00%)  1/98 (1.02%)  2/91 (2.20%)  2/80 (2.50%) 
Coronary Artery Dissection  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Coronary Artery Occlusion  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Ischaemic Cardiomyopathy  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Left Ventricular Failure  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Sinus Node Dysfunction  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Tachycardia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Ventricular Fibrillation  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Ventricular Tachycardia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Gastrointestinal disorders         
Abdominal Hernia  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Abdominal Pain  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Anal Incontinence  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Change of Bowel Habit  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Colitis  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Colitis Ischaemic  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Fistula of Small Intestine  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Gastritis  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Gastrointestinal Haemorrhage  1  1/100 (1.00%)  1/98 (1.02%)  0/91 (0.00%)  1/80 (1.25%) 
Ileus  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Intestinal Strangulation  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Pancreatitis Acute  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
General disorders         
Death  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Pyrexia  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Stent-Graft Endoleak  1  1/100 (1.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Hepatobiliary disorders         
Cholangitis  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Cholecystitis Acute  1  1/100 (1.00%)  1/98 (1.02%)  0/91 (0.00%)  1/80 (1.25%) 
Immune system disorders         
Anaphylactic Shock  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Infections and infestations         
Bacterial Sepsis  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Bronchitis  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Device Related Infection  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Localised Infection  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Pneumonia  1  0/100 (0.00%)  3/98 (3.06%)  5/91 (5.49%)  2/80 (2.50%) 
Pulmonary Sepsis  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Sepsis  1  2/100 (2.00%)  2/98 (2.04%)  2/91 (2.20%)  0/80 (0.00%) 
Septic Shock  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Urinary Tract Infection Bacterial  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Urinary Tract Infection Staphylococcal  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Urosepsis  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Injury, poisoning and procedural complications         
Cervical Vertebral Fracture  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Facial Bones Fracture  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Femoral Neck Fracture  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Hand Fracture  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Hip Fracture  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Overdose  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Post Lumbar Puncture Syndrome  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Postoperative Delirium  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Respiratory Tract Procedural Complication  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Spinal Compression Fracture  1  1/100 (1.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Spinal Fracture  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Tracheal Haemorrhage  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Vascular Pseudoaneurysm  1  1/100 (1.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Wound Dehiscence  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Investigations         
Blood Creatinine Increased  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Weight Decreased  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Metabolism and nutrition disorders         
Failure to Thrive  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Fluid Overload  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Hypokalaemia  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Hyponatraemia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Malnutrition  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Vitamin D Deficiency  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthritis  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Muscular Weakness  1  1/100 (1.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Pain in Extremity  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Pseudarthrosis  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Adenocarcinoma Pancreas  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Bladder Cancer Recurrent  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Intraductal Papillary Mucinous Neoplasm  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Lung Squamous Cell Carcinoma Stage Iii  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Myeloproliferative Neoplasm  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Oesophageal Neoplasm  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Nervous system disorders         
Cerebellar Infarction  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  2/80 (2.50%) 
Cerebral Infarction  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Cerebralvascular Accident  1  2/100 (2.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Dementia with Lewy Bodies  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Embolic Stroke  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Hypoaesthesia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Ischaemic Stroke  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Lacunar Stroke  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Metabolic Encephalopathy  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Paraplegia  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Parkinson's Disease  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Spinal Cord Iscaemia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Syncope  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Transient Ischaemic Attack  1  0/100 (0.00%)  1/98 (1.02%)  1/91 (1.10%)  0/80 (0.00%) 
Product Issues         
Device Breakage  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Psychiatric disorders         
Delirium Tremens  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Mental Status Changes  1  1/100 (1.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Suicidal Ideation  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Renal and urinary disorders         
Acute Kidney Injury  1  0/100 (0.00%)  2/98 (2.04%)  2/91 (2.20%)  1/80 (1.25%) 
End Stage Renal Disease  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Renal Tubular Necrosis  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Ureteric Obstruction  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Urinary Bladder Polyp  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Urinary Incontinence  1  1/100 (1.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Acute Respiratory Failure  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Atelectasis  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Chronic Obstructive Pulmonary Disease  1  1/100 (1.00%)  3/98 (3.06%)  1/91 (1.10%)  2/80 (2.50%) 
Chylothorax  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Dyspnoea  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Hypoxia  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Pleurisy  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Pulmonary Congestion  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Pulmonary Embolism  1  1/100 (1.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Pulmonary Fibrosis  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Pulmonary Hypertension  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Pulmonary Mass  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Respiratory Distress  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Respiratory Failure  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  1/80 (1.25%) 
Surgical and medical procedures         
Neurectomy  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Vascular disorders         
Aortic Aneurysm  1  0/100 (0.00%)  2/98 (2.04%)  1/91 (1.10%)  2/80 (2.50%) 
Aortic Dissection  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Aortic Rupture  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Atheroembolism  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Haemorrhage  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Hypertension  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Hypertensive Urgency  1  1/100 (1.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Iliac Artery Stenosis  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Orthostatic Hypotension  1  0/100 (0.00%)  2/98 (2.04%)  1/91 (1.10%)  0/80 (0.00%) 
Peripheral Artery Occlusion  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Peripheral Artery Thrombosis  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Peripheral Ischaemia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Thrombophlebitis  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
1
Term from vocabulary, MedDRA23
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Endovascular Repair 30-Day Secondary Endpoint Endovascular Repair 6-Month Secondary Endpoint Endovascular Repair 12-Month Secondary Endpoint Endovascular Repair 24-Month Secondary Endpoint
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   62/100 (62.00%)   31/98 (31.63%)   18/91 (19.78%)   20/80 (25.00%) 
Blood and lymphatic system disorders         
Anaemia  1  8/100 (8.00%)  2/98 (2.04%)  1/91 (1.10%)  0/80 (0.00%) 
Iron Deficiency Anaemia  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Leukocytosis  1  5/100 (5.00%)  2/98 (2.04%)  0/91 (0.00%)  1/80 (1.25%) 
Thrombocytopenia  1  2/100 (2.00%)  2/98 (2.04%)  0/91 (0.00%)  0/80 (0.00%) 
Cardiac disorders         
Acute Myocardial Infarction  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Angina Pectoris  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Aortic Valve Stenosis  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Atrial Fibrillation  1  2/100 (2.00%)  1/98 (1.02%)  1/91 (1.10%)  1/80 (1.25%) 
Atrial Flutter  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Atrial Tachycardia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Atrioventricular Block First Degree  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Bradycardia  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Cardiac Failure Congestive  1  0/100 (0.00%)  3/98 (3.06%)  2/91 (2.20%)  1/80 (1.25%) 
Hypertensive Cardiomyopathy  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Palpitations  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Pericardial Effusion  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Sinus Bradycardia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Sinus Tachycardia  1  2/100 (2.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Supraventricular Tachycardia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Torsade De Pointes  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Ventricular Extrasystoles  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Ventricular Tachycardia  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Congenital, familial and genetic disorders         
Congenital Hypercoagulation  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Gastrointestinal Arteriovenous Malformation  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Loeys-Dietz Syndrome  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Ear and labyrinth disorders         
Vertigo  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Gastrointestinal disorders         
Abdominal Pain Lower  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Abdominal Pain Upper  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Abdominal Tenderness  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Abdominal Wall Haematoma  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Colitis Ischaemic  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Constipation  1  3/100 (3.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Diverticulum  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Dysphagia  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Gastrointestinal Angiectasia  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Gastrointestinal Haemorrhage  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Haematochezia  1  0/100 (0.00%)  1/98 (1.02%)  1/91 (1.10%)  0/80 (0.00%) 
Hiatus Hernia  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Ileus  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Presbyoesophagus  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
General disorders         
Asthenia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Chest Pain  1  2/100 (2.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Facial Pain  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Fatigue  1  1/100 (1.00%)  0/98 (0.00%)  1/91 (1.10%)  1/80 (1.25%) 
Generalized Oedema  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Non-Cardiac Chest Pain  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Oedema  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Oedema Peripheral  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Peripheral Swelling  1  1/100 (1.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Puncture Site Haemorrhage  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Pyrexia  1  6/100 (6.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Stent-Graft Endoleak  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Infections and infestations         
Cellulitis  2  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Central Nervous System Infection  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Clostridium Difficile Colitis  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Cystitis  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Gastroenteritis  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Groin Abscess  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Influenza  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Oesophageal Candidiasis  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Pneumonia  1  1/100 (1.00%)  3/98 (3.06%)  1/91 (1.10%)  0/80 (0.00%) 
Pneumonia Staphylococcal  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Post Procedural Sepsis  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Skin Infection  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Upper Respiratory Tract Infection  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  1/80 (1.25%) 
Urinary Tract Infection  1  7/100 (7.00%)  3/98 (3.06%)  1/91 (1.10%)  3/80 (3.75%) 
Injury, poisoning and procedural complications         
Anaemia Postoperative  2  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Aortic Injury  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Cervical Vertebral Fracture  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Corneal Abrasion  2  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Fall  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Incision Site Erythema  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Incision Site Pain  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Joint Dislocation  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Post Procedural Fever  1  3/100 (3.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Postimplantation Syndrome  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Postoperative Delirium  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Postoperative Respiratory Failure  1  3/100 (3.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Procedural Haemorrhage  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Procedural Hypotension  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Procedural Site Reaction  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Radius Fracture  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Seroma  1  1/100 (1.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Spinal Compression Fracture  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Sternal Fracture  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Traumatic Haematoma  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Vascular Access Site Complication  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Vascular Access Site Haematoma  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Vascular Access Site Haemorrhage  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Vascular Pseudoaneurysm  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Wound Dehiscence  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Investigations         
Blood Creatine Phosphokinase Increased  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Blood Magnesium Decreased  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Blood Pressure Increased  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Oxygen Saturation Decreased  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Transaminases Increased  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Troponin I Increased  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Troponin Increased  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Urine Output Decreased  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Metabolism and nutrition disorders         
Electrolyte Imbalance  2  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Fluid Overload  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Gout  1  1/100 (1.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Hyperkalaemia  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Hyperlipasaemia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Hypernatraemia  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Hypokalaemia  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Hyponatraemia  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Hypophosphataemia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Malnutrition  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Back Pain  1  5/100 (5.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Costochondritis  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Fibromyalgia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Haemarthrosis  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Joint Swelling  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Muscular Weakness  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Musculoskeletal Chest Pain  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Musculoskeletal Pain  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Basal Cell Carcinoma  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  2/80 (2.50%) 
Bowen's Disease  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Lung Neoplasm Malignant  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Prostate Cancer  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Renal Neoplasm  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Nervous system disorders         
Asterixis  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Carotid Artery Dissection  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Carotid Artery Stenosis  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Dizziness  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Encephalopathy  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Headache  1  3/100 (3.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Hypoaesthesia  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Neuralgia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Neurological Decompensation  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Paraesthesia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Parkinson's Disease  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Presyncope  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Radial Nerve Palsy  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Spinal Cord Infarction  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Spinal Subarachnoid Haemorrhage  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Psychiatric disorders         
Anxiety  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Confusional State  1  3/100 (3.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Delirium  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Depression  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Mental Status Changes  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Renal and urinary disorders         
Acute Kidney Injury  2  3/100 (3.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Chronic Kidney Disease  1  0/100 (0.00%)  2/98 (2.04%)  0/91 (0.00%)  0/80 (0.00%) 
Haematuria  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Renal Failure  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Renal Ischaemia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Renal Mass  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Urinary Incontinence  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Urinary Retention  1  3/100 (3.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Reproductive system and breast disorders         
Prostatomegaly  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Respiratory, thoracic and mediastinal disorders         
Acute Respiratory Failure  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Atelectasis  1  5/100 (5.00%)  0/98 (0.00%)  0/91 (0.00%)  2/80 (2.50%) 
Chronic Obstructive Pulmonary Disease  1  1/100 (1.00%)  2/98 (2.04%)  0/91 (0.00%)  0/80 (0.00%) 
Cough  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Diaphragmatic Paralysis  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Dysphonia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Dyspnoea  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Dyspnoea Exertional  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Epistaxis  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Hypercapnia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Lung Consolidation  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Lung Infiltration  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Lung Opacity  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Painful Respiration  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Pleural Effusion  1  12/100 (12.00%)  1/98 (1.02%)  1/91 (1.10%)  2/80 (2.50%) 
Pleurisy  2  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Pleuritic Pain  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Pulmonary Mass  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Pulmonary Oedema  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Respiratory Acidosis  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Skin and subcutaneous tissue disorders         
Drug Eruption  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Keloid Scar  1  0/100 (0.00%)  0/98 (0.00%)  1/91 (1.10%)  0/80 (0.00%) 
Petechiae  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Pruritus  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Rash  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Vascular disorders         
Aortic Aneurysm  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  2/80 (2.50%) 
Aortic Dissection  1  0/100 (0.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Deep Vein Thrombosis  1  0/100 (0.00%)  2/98 (2.04%)  0/91 (0.00%)  0/80 (0.00%) 
Haematoma  1  2/100 (2.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Hypertension  1  7/100 (7.00%)  4/98 (4.08%)  0/91 (0.00%)  0/80 (0.00%) 
Hypotension  1  4/100 (4.00%)  1/98 (1.02%)  0/91 (0.00%)  0/80 (0.00%) 
Jugular Vein Thrombosis  1  0/100 (0.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Peripheral Arterial Occlusive Disease  1  0/100 (0.00%)  2/98 (2.04%)  0/91 (0.00%)  2/80 (2.50%) 
Peripheral Embolism  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  0/80 (0.00%) 
Peripheral Ischaemia  1  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
Subclavian Artery Stenosis  2  1/100 (1.00%)  0/98 (0.00%)  0/91 (0.00%)  1/80 (1.25%) 
1
Term from vocabulary, MedDRA23
2
Term from vocabulary, MedDRA21
Indicates events were collected by systematic assessment
Clinical evidence collected as part of the Valiant Evo US Clinical Trial (NCT02652949) and the Valiant Evo International Clinical Trial (NCT02625324) are combined to support commercial marketing approvals.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Medtronic owns the data of this clinical study, a single investigation site may access and use the data provided by itself for scientific publications following prior approval by Medtronic.

Pooling data from several investigation sites for publication purposes, national projects and international projects all require prior approval from Medtronic.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Katrin Dias - Clinical Study Manager
Organization: Medtronic
Phone: 707-525-0111
EMail: katrin.a.dias@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT02652949    
Other Study ID Numbers: 10219498DOC
First Submitted: January 8, 2016
First Posted: January 12, 2016
Results First Submitted: December 10, 2018
Results First Posted: February 26, 2019
Last Update Posted: June 11, 2021