Valiant Evo US Clinical Trial (VEVO)

• ClinicalTrials.gov Identifier: NCT02652949
• Recruitment Status: Active, not recruiting
• First Posted: January 12, 2016
• Results First Posted: February 26, 2019
• Last Update Posted: December 22, 2022
• Sponsor: Medtronic Cardiovascular
• 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

Participant Flow

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
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	53
Not Completed	34
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	27
Period Title: 36-Month Follow-up Secondary Endpoint
Started	53
Completed	49
Not Completed	4
Reason Not Completed
Death	2
Withdrawal by Subject	1
Subject declined extended follow up at 12 month timepoint. Data entry error-to be corrected by site	1

Baseline Characteristics

Arm/Group Title		Endovascular Repair
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
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

Outcome Measures

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
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

Outcome Measure Data

Analysis Population Description

The 30-day primary endpoint was evaluated for Pre-Market Approval (PMA) approval when 87 subjects completed 30 day follow-up.

Arm/Group Title	Endovascular Repair
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%

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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
		3 5.8%
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
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

Outcome Measure Data

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
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
		55 55.0%
Secondary Procedures	Number Analyzed	89 participants
		5 5.6%
Loss of Stent Graft Patency	Number Analyzed	79 participants
		0 0.0%
Endoleaks	Number Analyzed	78 participants
		5 6.4%
Stent Graft Migration	Number Analyzed	79 participants
		0 0.0%
Aneurysm Expansion >5 mm relative to 1-Month	Number Analyzed	78 participants
		4 5.1%

5. Secondary Outcome

Title	Safety and Effectiveness Outcome
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

Outcome Measure Data

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
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 (ACM)	Number Analyzed	80 participants
		13 16.3%
Aneurysm-Related Mortality (ARM)	Number Analyzed	72 participants
		3 4.2%
Major Device Effects (MDE)	Number Analyzed	72 participants
		5 6.9%
Adverse Events (AE)	Number Analyzed	99 participants
		85 85.9%
Major Adverse Event (MAE)	Number Analyzed	99 participants
		49 49.5%
Serious Adverse Event (SAE)	Number Analyzed	99 participants
		61 61.6%
Secondary Procedures	Number Analyzed	71 participants
		6 8.5%
Loss of Stent Graft Patency	Number Analyzed	50 participants
		0 0.0%
Endoleaks	Number Analyzed	48 participants
		2 4.2%
Stent Graft Migration	Number Analyzed	49 participants
		0 0.0%
Aneurysm Expansion >5 mm relative to 1-Month	Number Analyzed	51 participants
		4 7.8%

6. Secondary Outcome

Title	Safety and Effectiveness Outcome
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

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
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 (ACM)	Number Analyzed	78 participants
		14 17.9%
Aneurysm-Related Mortality (ARM)	Number Analyzed	67 participants
		3 4.5%
Major Device Effects (MDE)	Number Analyzed	68 participants
		6 8.8%
Adverse Events (AE)	Number Analyzed	99 participants
		88 88.9%
Major Adverse Events (MAE)	Number Analyzed	99 participants
		51 51.5%
Serious Adverse Events (SAE)	Number Analyzed	99 participants
		64 64.6%
Secondary Procedures	Number Analyzed	68 participants
		6 8.8%
Loss of Stent Graft Patency	Number Analyzed	37 participants
		0 0.0%
Endoleaks	Number Analyzed	36 participants
		3 8.3%
Stent Graft Migration	Number Analyzed	42 participants
		1 2.4%
Aneurysm Expansion >5 mm relative to 1-Month	Number Analyzed	40 participants
		4 10.0%

7. Secondary Outcome

Title	Safety and Effectiveness Outcome
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
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

Adverse Events

Time Frame	Adverse Events and All-Cause Mortality at 30 Days, 6 Months, 12 Months, 24 Months and 36 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	Endovascular Repair 36-Month Secondary Endpoint
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.	Subjects treated with the Valiant Evo Thoracic Stent Graft, who experienced all-cause mortality within 0-1095 days, or one or more serious adverse event within 731-1095 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 36-Month time period or were followed for at least 914 days. For Adverse Events, the 36-Month time period for reporting is 731-1095 days. The number of participants at risk includes the number of subjects at risk at the beginning of the 36-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	Endovascular Repair 36-Month Secondary Endpoint
	Affected / at Risk (%)	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%)	13/80 (16.25%)	14/78 (17.95%)
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	Endovascular Repair 36-Month Secondary Endpoint
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	32/100 (32.00%)	27/98 (27.55%)	22/91 (24.18%)	16/83 (19.28%)	12/64 (18.75%)
Blood and lymphatic system disorders
Anaemia † 1	0/100 (0.00%)	2/98 (2.04%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Anaemia of Chronic Disease † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Blood Loss Anaemia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Neutrophilia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Splenic Lesion † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Cardiac disorders
Acute Myocardial Infarction † 1	1/100 (1.00%)	0/98 (0.00%)	1/91 (1.10%)	2/83 (2.41%)	0/64 (0.00%)
Angina Unstable † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Atrial Fibrillation † 1	3/100 (3.00%)	2/98 (2.04%)	1/91 (1.10%)	1/83 (1.20%)	0/64 (0.00%)
Atrioventricular Block † 1	1/100 (1.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Cardiac Failure † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Cardiac Failure Congestive † 1	2/100 (2.00%)	1/98 (1.02%)	2/91 (2.20%)	3/83 (3.61%)	1/64 (1.56%)
Coronary Artery Dissection † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Coronary Artery Occlusion † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Ischaemic Cardiomyopathy † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Left Ventricular Failure † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Sinus Node Dysfunction † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Tachycardia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Ventricular Fibrillation † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Ventricular Tachycardia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Eye disorders
Retinal Detachment † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Gastrointestinal disorders
Abdominal Hernia † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Abdominal Pain † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Anal Incontinence † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Change of Bowel Habit † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Colitis † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Colitis Ischaemic † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Dysphagia † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Enteritis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Fistula of Small Intestine † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Gastritis † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Gastrointestinal Haemorrhage † 1	1/100 (1.00%)	1/98 (1.02%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Haemorrhoidal Haemorrhage † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Ileus † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Inguinal Hernia † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Intestinal Strangulation † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Pancreatitis Acute † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Small Intestinal Obstruction † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
General disorders
Death † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pyrexia † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Stent-Graft Endoleak † 1	1/100 (1.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Vascular Stent Thrombosis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Hepatobiliary disorders
Cholangitis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Cholecystitis Acute † 1	1/100 (1.00%)	1/98 (1.02%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Immune system disorders
Anaphylactic Shock † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Infections and infestations
Bacterial Sepsis † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Bronchitis † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Localised Infection † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Pneumonia † 1	0/100 (0.00%)	3/98 (3.06%)	5/91 (5.49%)	2/83 (2.41%)	0/64 (0.00%)
Pulmonary Sepsis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Sepsis † 1	2/100 (2.00%)	2/98 (2.04%)	2/91 (2.20%)	0/83 (0.00%)	0/64 (0.00%)
Septic Shock † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Urinary Tract Infection † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Urinary Tract Infection Bacterial † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Urinary Tract Infection Staphylococcal † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Urosepsis † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Vascular Device Infection † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Injury, poisoning and procedural complications
Cervical Vertebral Fracture † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Facial Bones Fracture † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Femoral Neck Fracture † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Hand Fracture † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Hip Fracture † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Incomplete Spinal Fusion † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Overdose † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Post Lumbar Puncture Syndrome † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Postoperative Delirium † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Respiratory Tract Procedural Complication † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Spinal Compression Fracture † 1	1/100 (1.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Spinal Fracture † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Tracheal Haemorrhage † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Vascular Pseudoaneurysm † 1	1/100 (1.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Wound Dehiscence † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Investigations
Blood Creatinine Increased † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Weight Decreased † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Metabolism and nutrition disorders
Failure to Thrive † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Fluid Overload † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Hypokalaemia † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Hyponatraemia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Malnutrition † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Vitamin D Deficiency † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Musculoskeletal and connective tissue disorders
Arthritis † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Muscular Weakness † 1	1/100 (1.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pain in Extremity † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pseudarthrosis † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (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%)	1/83 (1.20%)	0/64 (0.00%)
Bladder Cancer Recurrent † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Intraductal Papillary Mucinous Neoplasm † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Lung Squamous Cell Carcinoma Stage Iii † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Metastatic Neoplasm † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Myeloproliferative Neoplasm † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Oesophageal Neoplasm † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Nervous system disorders
Cerebellar Infarction † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	2/83 (2.41%)	0/64 (0.00%)
Cerebral Infarction † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Cerebralvascular Accident † 1	2/100 (2.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Dementia with Lewy Bodies † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Embolic Stroke † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Guillain-Barre Syndrome † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Hypoaesthesia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Ischaemic Stroke † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Lacunar Stroke † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Metabolic Encephalopathy † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Paraplegia † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Parkinson's Disease † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Spinal Cord Ischaemia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Syncope † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Transient Ischaemic Attack † 1	0/100 (0.00%)	1/98 (1.02%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Vascular Encephalopathy † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Product Issues
Device Breakage † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Psychiatric disorders
Delirium Tremens † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Depression † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Mental Status Changes † 1	1/100 (1.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Suicidal Ideation † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Renal and urinary disorders
Acute Kidney Injury † 1	0/100 (0.00%)	2/98 (2.04%)	2/91 (2.20%)	1/83 (1.20%)	0/64 (0.00%)
End Stage Renal Disease † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Nephrolithiasis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Renal Tubular Necrosis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Ureteric Obstruction † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Urinary Bladder Polyp † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Urinary Incontinence † 1	1/100 (1.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure † 1	1/100 (1.00%)	0/98 (0.00%)	1/91 (1.10%)	1/83 (1.20%)	0/64 (0.00%)
Atelectasis † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Chronic Obstructive Pulmonary Disease † 1	1/100 (1.00%)	3/98 (3.06%)	1/91 (1.10%)	2/83 (2.41%)	1/64 (1.56%)
Chylothorax † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Dyspnoea † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Hypoxia † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pleurisy † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pulmonary Congestion † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pulmonary Embolism † 1	1/100 (1.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pulmonary Fibrosis † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pulmonary Hypertension † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Pulmonary Mass † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Respiratory Distress † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Respiratory Failure † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	2/64 (3.13%)
Vascular disorders
Aortic Aneurysm † 1	0/100 (0.00%)	2/98 (2.04%)	1/91 (1.10%)	2/83 (2.41%)	0/64 (0.00%)
Aortic Dissection † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Aortic Rupture † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Atheroembolism † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Haemorrhage † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Hypertension † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Hypertensive Urgency † 1	1/100 (1.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Iliac Artery Stenosis † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Orthostatic Hypotension † 1	0/100 (0.00%)	2/98 (2.04%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Peripheral Arterial Occlusive Disease † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Peripheral Artery Occlusion † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Peripheral Artery Thrombosis † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Peripheral Ischaemia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Thrombophlebitis † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
1 Term from vocabulary, MedDRA24; † Indicates events were collected by systematic assessment
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	Endovascular Repair 36-Month Secondary Endpoint
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	62/100 (62.00%)	31/98 (31.63%)	20/91 (21.98%)	19/83 (22.89%)	13/64 (20.31%)
Blood and lymphatic system disorders
Anaemia † 1	8/100 (8.00%)	2/98 (2.04%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Iron Deficiency Anaemia † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Leukocytosis † 1	5/100 (5.00%)	2/98 (2.04%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Thrombocytopenia † 1	2/100 (2.00%)	2/98 (2.04%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Cardiac disorders
Acute Myocardial Infarction † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Angina Pectoris † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Aortic Valve Stenosis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Atrial Fibrillation † 1	2/100 (2.00%)	1/98 (1.02%)	1/91 (1.10%)	1/83 (1.20%)	0/64 (0.00%)
Atrial Flutter † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Atrial Tachycardia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Atrioventricular Block First Degree † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Bradycardia † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Cardiac Failure Congestive † 1	0/100 (0.00%)	3/98 (3.06%)	2/91 (2.20%)	1/83 (1.20%)	0/64 (0.00%)
Coronary Artery Disease † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Hypertensive Cardiomyopathy † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Palpitations † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	1/64 (1.56%)
Pericardial Effusion † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Sinus Bradycardia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Sinus Tachycardia † 1	2/100 (2.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Supraventricular Tachycardia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Torsade De Pointes † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Ventricular Extrasystoles † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Ventricular Tachycardia † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Congenital, familial and genetic disorders
Congenital Hypercoagulation † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Gastrointestinal Arteriovenous Malformation † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Loeys-Dietz Syndrome † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Ear and labyrinth disorders
Vertigo † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Gastrointestinal disorders
Abdominal Pain Lower † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Abdominal Pain Upper † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Abdominal Tenderness † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Abdominal Wall Haematoma † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Colitis Ischaemic † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Constipation † 1	3/100 (3.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Diverticulum † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Dysphagia † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Gastrointestinal Angiectasia † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Gastrointestinal Haemorrhage † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Haematochezia † 1	0/100 (0.00%)	1/98 (1.02%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Hiatus Hernia † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Ileus † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Presbyoesophagus † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
General disorders
Asthenia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Chest Pain † 1	2/100 (2.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Facial Pain † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Fatigue † 1	1/100 (1.00%)	0/98 (0.00%)	1/91 (1.10%)	1/83 (1.20%)	0/64 (0.00%)
Generalized Oedema † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Influenza Like Illness † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Non-Cardiac Chest Pain † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Oedema † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Oedema Peripheral † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Peripheral Swelling † 1	1/100 (1.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Puncture Site Haemorrhage † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pyrexia † 1	6/100 (6.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Stent-Graft Endoleak † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Infections and infestations
Cellulitis † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Central Nervous System Infection † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Clostridium Difficile Colitis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Epididymitis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Gastroenteritis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Groin Abscess † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Influenza † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Oesophageal Candidiasis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Pneumonia † 1	1/100 (1.00%)	3/98 (3.06%)	1/91 (1.10%)	0/83 (0.00%)	1/64 (1.56%)
Pneumonia Staphylococcal † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Post Procedural Sepsis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Skin Infection † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Upper Respiratory Tract Infection † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	1/83 (1.20%)	1/64 (1.56%)
Urinary Tract Infection † 1	7/100 (7.00%)	3/98 (3.06%)	1/91 (1.10%)	3/83 (3.61%)	0/64 (0.00%)
Injury, poisoning and procedural complications
Anaemia Postoperative † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Aortic Injury † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Bone Contusion † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Cervical Vertebral Fracture † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Corneal Abrasion † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Fall † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Incision Site Erythema † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Incision Site Pain † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Joint Dislocation † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Ligament Rupture † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Post Procedural Fever † 1	3/100 (3.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Postimplantation Syndrome † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Postoperative Delirium † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Postoperative Respiratory Failure † 1	3/100 (3.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Procedural Haemorrhage † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Procedural Hypotension † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Procedural Site Reaction † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Radius Fracture † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Seroma † 1	1/100 (1.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Spinal Compression Fracture † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Sternal Fracture † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Traumatic Haematoma † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Vascular Access Site Complication † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Vascular Access Site Haematoma † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Vascular Access Site Haemorrhage † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Vascular Pseudoaneurysm † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Wound Dehiscence † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Investigations
Blood Creatine Phosphokinase Increased † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Blood Magnesium Decreased † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Blood Pressure Increased † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Oxygen Saturation Decreased † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Transaminases Increased † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Troponin I Increased † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Troponin Increased † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Urine Output Decreased † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Metabolism and nutrition disorders
Electrolyte Imbalance † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Fluid Overload † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Gout † 1	1/100 (1.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Hyperkalaemia † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Hyperlipasaemia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Hypernatraemia † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Hypokalaemia † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Hyponatraemia † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Hypophosphataemia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Malnutrition † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Back Pain † 1	5/100 (5.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Costochondritis † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Fibromyalgia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Haemarthrosis † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Joint Swelling † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Muscular Weakness † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Musculoskeletal Chest Pain † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (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%)	2/83 (2.41%)	0/64 (0.00%)
Bowen's Disease † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Lung Neoplasm Malignant † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Prostate Cancer † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Renal Neoplasm † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Nervous system disorders
Asterixis † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Carotid Artery Dissection † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Carotid Artery Stenosis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Dizziness † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Encephalopathy † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Headache † 1	3/100 (3.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Hypoaesthesia † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Morton's Neuralgia † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Neuralgia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Neurological Decompensation † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Paraesthesia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Parkinson's Disease † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Presyncope † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Radial Nerve Palsy † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Spinal Cord Infarction † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Spinal Subarachnoid Haemorrhage † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Psychiatric disorders
Anxiety † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Confusional State † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Delirium † 1	3/100 (3.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Depression † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Mental Status Changes † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Renal and urinary disorders
Acute Kidney Injury † 1	3/100 (3.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Chronic Kidney Disease † 1	0/100 (0.00%)	2/98 (2.04%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Cystitis Haemorrhagic † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Focal Segmental Glomerulosclerosis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Haematuria † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Renal Failure † 1	2/100 (2.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Renal Ischaemia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Renal Mass † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Urinary Incontinence † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Urinary Retention † 1	3/100 (3.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Reproductive system and breast disorders
Prostatomegaly † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Atelectasis † 1	5/100 (5.00%)	0/98 (0.00%)	0/91 (0.00%)	2/83 (2.41%)	0/64 (0.00%)
Chronic Obstructive Pulmonary Disease † 1	1/100 (1.00%)	2/98 (2.04%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Cough † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Diaphragmatic Paralysis † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Dysphonia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Dyspnoea † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Dyspnoea Exertional † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Epistaxis † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Hypercapnia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Lung Consolidation † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Lung Infiltration † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Lung Opacity † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Painful Respiration † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pleural Effusion † 1	12/100 (12.00%)	1/98 (1.02%)	1/91 (1.10%)	2/83 (2.41%)	0/64 (0.00%)
Pleurisy † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pleuritic Pain † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pulmonary Mass † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	1/64 (1.56%)
Pulmonary Oedema † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Respiratory Acidosis † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Skin and subcutaneous tissue disorders
Drug Eruption † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Keloid Scar † 1	0/100 (0.00%)	0/98 (0.00%)	1/91 (1.10%)	0/83 (0.00%)	0/64 (0.00%)
Petechiae † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Pruritus † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Rash † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Skin Reaction † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Vascular disorders
Aortic Aneurysm † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	2/83 (2.41%)	1/64 (1.56%)
Aortic Dissection † 1	0/100 (0.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Deep Vein Thrombosis † 1	0/100 (0.00%)	2/98 (2.04%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Haematoma † 1	2/100 (2.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Hypertension † 1	7/100 (7.00%)	4/98 (4.08%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
Hypotension † 1	4/100 (4.00%)	1/98 (1.02%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Jugular Vein Thrombosis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Peripheral Arterial Occlusive Disease † 1	0/100 (0.00%)	2/98 (2.04%)	0/91 (0.00%)	2/83 (2.41%)	0/64 (0.00%)
Peripheral Embolism † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	0/64 (0.00%)
Peripheral Ischaemia † 1	1/100 (1.00%)	0/98 (0.00%)	0/91 (0.00%)	1/83 (1.20%)	0/64 (0.00%)
Subclavian Artery Stenosis † 1	1/100 (1.00%)	0/98 (0.00%)	1/91 (1.10%)	1/83 (1.20%)	0/64 (0.00%)
Subclavian Artery Thrombosis † 1	0/100 (0.00%)	0/98 (0.00%)	0/91 (0.00%)	0/83 (0.00%)	1/64 (1.56%)
1 Term from vocabulary, MedDRA24; † Indicates events were collected by systematic assessment

Limitations and Caveats

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.

More Information

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

• Name/Title: Katrin Dias - Clinical Study Manager
• Organization: Medtronic
• Phone: 707-525-0111
• EMail: katrin.a.dias@medtronic.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Verzini F, Cieri E, Kahlberg A, Sternbach Y, Heijmen R, Ouriel K, Robaina S, Azizzadeh A. A preliminary analysis of late structural failures of the Navion stent graft in the treatment of descending thoracic aortic aneurysms. J Vasc Surg. 2021 Oct;74(4):1125-1134.e2. doi: 10.1016/j.jvs.2021.04.018. Epub 2021 Apr 20.

Azizzadeh A, Desai N, Arko FR 3rd, Panneton JM, Thaveau F, Hayes P, Dagenais F, Lei L, Verzini F. Pivotal results for the Valiant Navion stent graft system in the Valiant EVO global clinical trial. J Vasc Surg. 2019 Nov;70(5):1399-1408.e1. doi: 10.1016/j.jvs.2019.01.067. Epub 2019 May 21.

• 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: December 22, 2022