Trial Outcomes & Findings for Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE) (NCT NCT00805948)

Last Updated: 2021-09-27

Results Overview

For all THRIVE subjects, Aneurysm-Related Mortality (ARM) is defined as: Death from rupture of the thoracic aortic aneurysm or from any procedure intended to treat the Descending Thoracic Aneurysm (DTA - fusiform aneurysms and saccular aneurysms/penetrating ulcers) as determined by an independent Clinical Events Committee (CEC). If a death occurred within 30 days of any procedure intended to treat the DTA, then it is presumed to be aneurysm related, unless there is evidence to the contrary.

Recruitment status

TERMINATED

Study phase

Target enrollment

349 participants

Primary outcome timeframe

5 years

Results posted on

2021-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	De Novo Group 154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.	Valor Test Group 195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
Overall Study STARTED	154	195
Overall Study COMPLETED	86	99
Overall Study NOT COMPLETED	68	96

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	De Novo Group n=154 Participants 154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.	Valor Test Group n=195 Participants 195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.	Total n=349 Participants Total of all reporting groups
Age, Continuous	71.1 years STANDARD_DEVIATION 11.4 • n=5 Participants	70.2 years STANDARD_DEVIATION 11.1 • n=7 Participants	70.6 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	80 Participants n=7 Participants	154 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	115 Participants n=7 Participants	195 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	145 Participants n=5 Participants	190 Participants n=7 Participants	335 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Native Hawaiian or Pacific Islander	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized White	127 Participants n=5 Participants	162 Participants n=7 Participants	289 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Available	0 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: All participants were combined for analysis as a single arm, as pre-specified in the protocol. Subjects are censored because their last follow-up has not reached the end of the time interval or because they withdraw, are lost to follow-up or die from a non-aneurysm related cause.

Outcome measures

Outcome measures
Measure	All Subjects n=349 Participants All Subjects (349) is comprised of 195 subjects from the VALOR Test Group (PMA P070007) and 154 of the planned 256 De Novo subjects.	Valor Test Group 195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
Freedom From Aneurysm-related Mortality at 5 Years	92 Percentage of participants Interval 88.0 to 95.0	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 1, 12, 24, 36, 48 and 60 months

Population: Based on all Intent to Treat (ITT) subjects.

Number of subjects who died during that interval or who were followed at least until the lower endpoint of the analysis window.

Outcome measures

Outcome measures
Measure	All Subjects n=154 Participants All Subjects (349) is comprised of 195 subjects from the VALOR Test Group (PMA P070007) and 154 of the planned 256 De Novo subjects.	Valor Test Group n=195 Participants 195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
All-Cause Mortality 0-30 days	5 Participants	4 Participants
All-Cause Mortality 0 - 365 days	17 Participants	31 Participants
All-Cause Mortality 366 - 731 days	18 Participants	11 Participants
All-Cause Mortality 732 - 1096 days	8 Participants	15 Participants
All-Cause Mortality 1097 - 1461 days	8 Participants	9 Participants
All-Cause Mortality 1462 - 1826 days	3 Participants	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1, 12, 24, 36, 48 and 60 months

Population: Based on all Intent to Treat (ITT) subjects.

Conversion from endovascular to open repair required at the time of the original procedure or at the time beyond the initial endovascular procedure (for the same lesion treated during the initial implantation of the Talent Thoracic Stent Graft)

Outcome measures

Outcome measures
Measure	All Subjects n=154 Participants All Subjects (349) is comprised of 195 subjects from the VALOR Test Group (PMA P070007) and 154 of the planned 256 De Novo subjects.	Valor Test Group n=195 Participants 195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
Number of Participants With Conversion to Surgery 0-30 days	1 participants	0 participants
Number of Participants With Conversion to Surgery 0-365 days	2 participants	1 participants
Number of Participants With Conversion to Surgery 366-731 days	0 participants	1 participants
Number of Participants With Conversion to Surgery 732-1096 days	0 participants	1 participants
Number of Participants With Conversion to Surgery 1097-1461 days	0 participants	0 participants
Number of Participants With Conversion to Surgery 1462-1826 days	0 participants	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1, 12, 24, 36, 48 and 60 months

Population: Based on all Intent to Treat (ITT) subjects

Rupture or perforation of the targeted aneurismal sac as detected by angiography, CT scan, or direct observation at surgery or autopsy.

Outcome measures

Outcome measures
Measure	All Subjects n=154 Participants All Subjects (349) is comprised of 195 subjects from the VALOR Test Group (PMA P070007) and 154 of the planned 256 De Novo subjects.	Valor Test Group n=195 Participants 195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
Number of Participants With Aneurysm Rupture 366-731 days	2 participants	0 participants
Number of Participants With Aneurysm Rupture 0-30 days	0 participants	0 participants
Number of Participants With Aneurysm Rupture 0-365 days	0 participants	1 participants
Number of Participants With Aneurysm Rupture 732-1096 days	1 participants	2 participants
Number of Participants With Aneurysm Rupture 1097-1461 days	0 participants	0 participants
Number of Participants With Aneurysm Rupture 1462-1826 days	0 participants	2 participants

Adverse Events

De Novo Group

Serious events: 83 serious events

Other events: 0 other events

Deaths: 54 deaths

Valor Test Group

Serious events: 178 serious events

Other events: 0 other events

Deaths: 76 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Michael McGuffey, Clinical Research Director

Medtronic, Inc

Phone: 707-591-7126

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	De Novo Group n=154 participants at risk 154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.	Valor Test Group n=195 participants at risk 195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
Cardiac disorders Aortic Valve Disease	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Cardiac disorders Arrhythmia	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Cardiac disorders Cardiac Arrest	3.2% 5/154 • Number of events 5 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Cardiac disorders Cardiac Failure	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Cardiac disorders Cardiac Failure Congestive	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Cardiac disorders Cardiogenic Shock	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Cardiac disorders Cardiopulmonary Failure	1.3% 2/154 • Number of events 2 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Cardiac disorders Ischaemic Cardiomyopathy	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Cardiac disorders Myocardial Infarction	2.6% 4/154 • Number of events 4 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Gastrointestinal disorders Gastrointestinal Haemorrhage	1.3% 2/154 • Number of events 2 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Gastrointestinal disorders Intestinal Ischaemia	1.3% 2/154 • Number of events 2 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Gastrointestinal disorders Retroperitoneal Haemorrhage	1.3% 2/154 • Number of events 2 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Gastrointestinal disorders Umbilical Hernia	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
General disorders Device Dislocation	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
General disorders Multi-Organ Failure	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
General disorders Stent-Graft Endoleak	13.0% 20/154 • Number of events 23 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Infections and infestations Clostridium Difficile Colitis	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Infections and infestations Groin Infection	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Infections and infestations Infection	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	11.3% 22/195 • Number of events 28 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Infections and infestations Infective Aneurysm	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Infections and infestations Pneumonia	1.9% 3/154 • Number of events 4 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Infections and infestations Sepsis	3.9% 6/154 • Number of events 6 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Infections and infestations Wound Infection	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Injury, poisoning and procedural complications Procedural Haemorrhage	5.8% 9/154 • Number of events 9 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Injury, poisoning and procedural complications Vascular Pseudoaneurysm	0.65% 1/154 • Number of events 2 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Injury, poisoning and procedural complications Wound	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Musculoskeletal and connective tissue disorders Compartment Syndrome	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder Cancer	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases To Bone	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm Malignant	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer Metastatic	0.65% 1/154 • Number of events 1 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Nervous system disorders Cerebral Haemorrhage	1.9% 3/154 • Number of events 3 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Nervous system disorders Cerebrovascular Accident	4.5% 7/154 • Number of events 8 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Nervous system disorders Paraparesis	1.3% 2/154 • Number of events 2 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Psychiatric disorders Mental Status Changes	1.9% 3/154 • Number of events 3 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Renal and urinary disorders Renal Failure	7.1% 11/154 • Number of events 13 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Renal and urinary disorders Renal Failure Acute	1.3% 2/154 • Number of events 2 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.
Respiratory, thoracic and mediastinal disorders Acute Respiratory Distress Syndrome	1.3% 2/154 • Number of events 2 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.	— 0/0 • 5 years The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions. The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.