Valor II: The Valiant Thoracic Stent Graft System Clinical Study

• Sponsor: Medtronic Cardiovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00413231
• Collaborator: (none)
• Enrollment: 160
• Locations: 26
• Arm: 1
• Duration (Months): 94
• Patients Per Site: 6.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.

Condition or Disease	Intervention/Treatment	Phase
Thoracic Aortic Aneurysm	Device: Valiant Thoracic Stent Graft System	N/A

Detailed Description

The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. In this research study we are investigating a device that can be placed in the aorta to exclude the weakened part of the artery wall and restore blood flow. Information will be collected on the performance of the device for 5 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Valiant Thoracic Stent Graft System. The Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair.
• Study Start Date: Dec 1, 2006
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Valiant Thoracic Stent Graft System 160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device. There were no other arms for this study.	Device: Valiant Thoracic Stent Graft System; Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).; Other Names: Valiant device; Valiant stent graft.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint) [0 through 1825 days post treatment]

   Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.

2. Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint) [At 12-month post procedure]

   Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b. Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device. Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak).

3. Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > > [Within 12-months post treatment]

   The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated. > > Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks.

Secondary Outcome Measures

1. Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant [At implant]

   Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness.

2. Percentage of Participants That Experienced Perioperative Mortality [Within 30 days post treatment]

   Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.

3. Percentage of Participants That Experienced Paraplegia [Within 30 days post treatment]

   Percentage of subjects that experienced paraplegia within 30 days post treatment

4. Percentage of Participants That Experienced Paraparesis [Within 30 days post treatment]

   Percentage of subjects that experienced paraparesis within 30 days post treatment

5. Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge [Within 30 days post treatment]

   Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment

6. Percentage of Participants That Experienced One or More Major Adverse Events [Within 30 days post treatment]

   Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device

7. Percentage of Participants That Experienced Aneurysm-related Mortality [Within 12 months post treatment]

   Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment

8. Percentage of Participants That Experience Aneurysm Rupture [Within 12 months post treatment]

   Percentage of subjects that experience aneurysm rupture within 12 months post treatment

9. Percentage of Participants That Experienced Conversion to Open Surgical Repair [Within 12 months post treatment]

   Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment

10. Percentage of Participants That Experienced Endoleak(s) [At 12 months]

    Percentage of subjects that experienced endoleak(s) of any type at 12 months

11. Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak [Between 30 days and 12 months]

    Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months

12. Percentage of Participants That Experienced Stent Graft Migration [Within 12 months post treatment]

    Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations.

13. Percentage of Participants That Experience Loss of Stent Graft Patency [Within 12 months post treatment]

    Percentage of subjects that experience loss of stent graft patency within 12 months post treatment

14. Percentage of Participants That Experienced One or More Major Adverse Events [Within 12 months post treatment]

    Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment

15. Percentage of Participants That Died (All-cause Mortality) [0 through 1825 days post treatment]

    Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated

16. Percentage of Participants That Experienced Aneurysm-related Mortality [0 through 1825 days post treatment]

    Percentage of subjects that experienced aneurysm-related within five years post implant

17. Percentage of Participants That Experienced Aneurysm Ruptures [0 through 1825 days post treatment]

    Percentage of subjects that experienced aneurysm ruptures within five years post implant

18. Percentage of Participants That Experienced Conversions to Open Surgical Repair [0 through 1825 days post treatment]

    Percentage of subjects that experienced conversions to open surgical repair within five years post implant

19. Percentage of Participants That Experienced Type I Endoleaks [0 through 1825 days post treatment]

    Percentage of subjects that experienced type I endoleaks within five years post implant

20. Percentage of Participants That Experienced Type III Endoleaks [0 through 1825 days post treatment]

    Percentage of subjects that experienced type III endoleaks within five years post implant

21. Percentage of Participants That Experienced Type IV Endoleaks [0 through 1825 days post treatment]

    Percentage of subjects that experienced type IV endoleaks within five years post implant

22. Percentage of Participants That Experienced Secondary Endovascular Procedures [0 through 1825 days post treatment]

    Percentage of subjects that experienced secondary endovascular procedures within five years post implant

23. Percentage of Participants That Experienced Stent Graft Migrations (Site Reported) [0 through 1825 days post treatment]

    Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites

24. Percentage of Participants That Experienced Loss of Stent Graft Patency [0 through 1825 days post treatment]

    Percentage of subjects that experienced loss of stent graft patency within five years post implant

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

The following inclusion/exclusion criteria was obtained from the study protocol.

INCLUSION CRITERIA

To be eligible for enrollment, a subject must meet all of the following inclusion criteria:

1. Subject is between the age of 18 and 85.

2. Subject must be considered a candidate for elective surgical repair of the TAA (i.e., low-to-moderate risk [categories 0, 1, and 2] per the modified SVS/AAVS scoring system at the time of implant). See Appendix B: Modified SVS/AAVS Medical Co-Morbidity Grading System

3. If subject is female of childbearing potential, she must have a negative pregnancy test within 7 days before the implant procedure.

4. Subject has a DTA that is:

5. A fusiform aneurysm with a maximum diameter of ≥ 5 cm OR is > 2 times the diameter of the non-aneurysmal thoracic aorta;

AND/OR

1. Saccular aneurysm (penetrating atherosclerotic ulcer)

2. Subject's anatomy must meet all of the following anatomical criteria:

3. Subject's TAA must be ≥ 20 mm distal to the origin of the left common carotid artery and must be ≥ 20 mm proximal to the celiac artery;

4. Proximal and distal non-aneurysmal neck diameter measurements must be between 20 mm and 42 mm;

5. Proximal and distal non-aneurysmal neck must be ≥ 20 mm in length.

6. Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CT) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram obtained within four (4) months prior to the implant procedure.

7. Subject is able and willing to comply with the protocol and undergo follow-up requirements.

8. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.

9. Subject has patent iliac or femoral arteries or can tolerate a vascular conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate size device chosen for treatment.

EXCLUSION CRITERIA

To be eligible for enrollment, a subject cannot meet any of the following exclusion criteria:

1. Planned placement of the COVERED portion of the stent graft requires implant to occur in zones 0 or 1.

2. Subject has a thoracic aneurysm with a contained rupture.

3. Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration).

4. Subject has a mycotic aneurysm or is suspected of having systemic infection.

5. Subject has received a previous stent or stent graft or previous surgical repair in the DTA.

6. Subject requires treatment of an infra-renal aneurysm at the time of implant.

7. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.

8. Subject has had or plans to have a major surgical procedure within 30 days before or after the Valiant Stent Graft procedure. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure).

9. Subject has had an MI or cerebral vascular accident (CVA) within 3 months.

10. Subject is currently participating in an investigational drug or device clinical trial.

11. Subject has a known allergy or intolerance to the device components.

12. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

13. Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise fixation and seal of the device.

14. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude him or her from receiving this treatment and the procedures and evaluations pre- and post-treatment, or a limited life expectancy of less than 1 year.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	University of Southern California - Healthcare Consultation Center	Los Angeles	California	United States	90033
3	Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center	Torrance	California	United States	90502
4	Hartford Hospital	Hartford	Connecticut	United States	06106
5	University of Florida	Gainesville	Florida	United States	32610
6	University of South Florida	Tampa	Florida	United States	33606
7	Emory University Hospital	Atlanta	Georgia	United States	30322
8	Loyola University Medical Center	Maywood	Illinois	United States	60153
9	Union Memorial	Baltimore	Maryland	United States	21218
10	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
11	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
12	Minneapolis Vascular Physicians	Plymouth	Minnesota	United States	55441
13	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
14	Advance Vascular Associates (Morristown Memorial Hospital)	Morristown	New Jersey	United States	07960
15	Albany Medical Center	Albany	New York	United States	12208
16	New York University Medical Center	New York	New York	United States	10016
17	Mount Sinai School of Medicine	New York	New York	United States	10029
18	University of North Carolina	Chapel Hill	North Carolina	United States	27599
19	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
20	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
21	Shadyside Hospital - University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15232
22	Baptist Memorial Hospital	Memphis	Tennessee	United States	38120
23	Baylor College of Medicine	Houston	Texas	United States	77030
24	St. Luke's Episcopal Hospital - Houston	Houston	Texas	United States	77030
25	University of Virginia	Charlottesville	Virginia	United States	22908
26	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042

Sponsors and Collaborators

• Medtronic Cardiovascular

Investigators

• Principal Investigator: Ronald Fairman, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Cardiovascular
• ClinicalTrials.gov Identifier: NCT00413231
• Other Study ID Numbers: Investigational Plan #078
• First Posted: Dec 19, 2006
• Last Update Posted: Nov 3, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Medtronic Cardiovascular: Thoracic Aneurysm; Endovascular Aortic Repair (EVAR); Endovascular Stent Graft; Endograft; Thoracic Aortic Aneurysm; Endovascular procedure; Descending Thoracic Aneurysm; Valiant Stent Graft System
• Additional relevant MeSH terms: Aneurysm, Dissecting; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic

Study Results

Participant Flow

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Period Title: 0 to 30-day Post Treatment
STARTED	160
COMPLETED	152
NOT COMPLETED	8
Period Title: 0 to 30-day Post Treatment
STARTED	152
COMPLETED	139
NOT COMPLETED	13
Period Title: 0 to 30-day Post Treatment
STARTED	139
COMPLETED	93
NOT COMPLETED	46

Baseline Characteristics

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Participants	160
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	26 16.3%
>=65 years	134 83.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.2 (9.1)
Sex: Female, Male (Count of Participants)
Female	65 40.6%
Male	95 59.4%
Region of Enrollment (participants) [Number]
United States	160 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
Description	Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.
Time Frame	0 through 1825 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number (90% Confidence Interval) [Percentage of participants]	94.8 59.3%

2. Secondary Outcome

Title	Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant
Description	Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness.
Time Frame	At implant

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device. There were no other arms for this study. Valiant Thoracic Stent Graft System: Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).
Measure Participants	160
Number (95% Confidence Interval) [Percentage of participants]	96.3 60.2%

3. Secondary Outcome

Title	Percentage of Participants That Experienced Perioperative Mortality
Description	Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.
Time Frame	Within 30 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number (95% Confidence Interval) [Percentage of participants]	3.1 1.9%

4. Secondary Outcome

Title	Percentage of Participants That Experienced Paraplegia
Description	Percentage of subjects that experienced paraplegia within 30 days post treatment
Time Frame	Within 30 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number (95% Confidence Interval) [Percentage of participants]	0.6 0.4%

5. Primary Outcome

Title	Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)
Description	Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b. Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device. Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak).
Time Frame	At 12-month post procedure

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number (95% Confidence Interval) [Percentage of Participants]	97.4 60.9%

6. Primary Outcome

Title	Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >
Description	The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated. > > Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks.
Time Frame	Within 12-months post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number (95% Confidence Interval) [Percentage of Participants]	12.6 7.9%

7. Secondary Outcome

Title	Percentage of Participants That Experienced Paraparesis
Description	Percentage of subjects that experienced paraparesis within 30 days post treatment
Time Frame	Within 30 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number (95% Confidence Interval) [Percentage of participants]	1.9 1.2%

8. Secondary Outcome

Title	Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge
Description	Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment
Time Frame	Within 30 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number (95% Confidence Interval) [Percentage of participants]	0.6 0.4%

9. Secondary Outcome

Title	Percentage of Participants That Experienced One or More Major Adverse Events
Description	Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device
Time Frame	Within 30 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number (95% Confidence Interval) [Percentage of participants]	38.1 23.8%

10. Secondary Outcome

Title	Percentage of Participants That Experienced Aneurysm-related Mortality
Description	Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment
Time Frame	Within 12 months post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device, excluding subjects exited before 12 months and implant failures

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	151
Number (95% Confidence Interval) [Percentage of participants]	3.3 2.1%

11. Secondary Outcome

Title	Percentage of Participants That Experience Aneurysm Rupture
Description	Percentage of subjects that experience aneurysm rupture within 12 months post treatment
Time Frame	Within 12 months post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device excluding subjects that exited before 12 months

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	154
Number (95% Confidence Interval) [Percentage of participants]	0 0%

12. Secondary Outcome

Title	Percentage of Participants That Experienced Conversion to Open Surgical Repair
Description	Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment
Time Frame	Within 12 months post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device excluding subjects exited before 12 months

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	154
Number (95% Confidence Interval) [Percentage of participants]	0 0%

13. Secondary Outcome

Title	Percentage of Participants That Experienced Endoleak(s)
Description	Percentage of subjects that experienced endoleak(s) of any type at 12 months
Time Frame	At 12 months

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device excluding subjects that did not have proper imaging to identify endoleaks

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	100
Number (95% Confidence Interval) [Percentage of participants]	13 8.1%

14. Secondary Outcome

Title	Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak
Description	Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months
Time Frame	Between 30 days and 12 months

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device excluding censored subjects (those with no data within the time frame)

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	143
Number (95% Confidence Interval) [Percentage of participants]	0 0%

15. Secondary Outcome

Title	Percentage of Participants That Experienced Stent Graft Migration
Description	Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations.
Time Frame	Within 12 months post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	105
Number (95% Confidence Interval) [Percentage of participants]	2.9 1.8%

16. Secondary Outcome

Title	Percentage of Participants That Experience Loss of Stent Graft Patency
Description	Percentage of subjects that experience loss of stent graft patency within 12 months post treatment
Time Frame	Within 12 months post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	100
Number (95% Confidence Interval) [Percentage of participants]	0 0%

17. Secondary Outcome

Title	Percentage of Participants That Experienced One or More Major Adverse Events
Description	Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment
Time Frame	Within 12 months post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device, excluded subjects that exited before 12 months

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	154
Number (95% Confidence Interval) [Percentage of participants]	48.7 30.4%

18. Secondary Outcome

Title	Percentage of Participants That Died (All-cause Mortality)
Description	Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated
Time Frame	0 through 1825 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number [Percentage of participants]	33.8 21.1%

19. Secondary Outcome

Title	Percentage of Participants That Experienced Aneurysm-related Mortality
Description	Percentage of subjects that experienced aneurysm-related within five years post implant
Time Frame	0 through 1825 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number [Percentage of participants]	5 3.1%

20. Secondary Outcome

Title	Percentage of Participants That Experienced Aneurysm Ruptures
Description	Percentage of subjects that experienced aneurysm ruptures within five years post implant
Time Frame	0 through 1825 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number [Percentage of participants]	1.3 0.8%

21. Secondary Outcome

Title	Percentage of Participants That Experienced Conversions to Open Surgical Repair
Description	Percentage of subjects that experienced conversions to open surgical repair within five years post implant
Time Frame	0 through 1825 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number [Percentage of participants]	0.6 0.4%

22. Secondary Outcome

Title	Percentage of Participants That Experienced Type I Endoleaks
Description	Percentage of subjects that experienced type I endoleaks within five years post implant
Time Frame	0 through 1825 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number [Percentage of participants]	8.1 5.1%

23. Secondary Outcome

Title	Percentage of Participants That Experienced Type III Endoleaks
Description	Percentage of subjects that experienced type III endoleaks within five years post implant
Time Frame	0 through 1825 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number [Percentage of participants]	0.6 0.4%

24. Secondary Outcome

Title	Percentage of Participants That Experienced Type IV Endoleaks
Description	Percentage of subjects that experienced type IV endoleaks within five years post implant
Time Frame	0 through 1825 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number [Percentage of participants]	1.3 0.8%

25. Secondary Outcome

Title	Percentage of Participants That Experienced Secondary Endovascular Procedures
Description	Percentage of subjects that experienced secondary endovascular procedures within five years post implant
Time Frame	0 through 1825 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number [Percentage of participants]	6.9 4.3%

26. Secondary Outcome

Title	Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)
Description	Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites
Time Frame	0 through 1825 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number [Percentage of participants]	0 0%

27. Secondary Outcome

Title	Percentage of Participants That Experienced Loss of Stent Graft Patency
Description	Percentage of subjects that experienced loss of stent graft patency within five years post implant
Time Frame	0 through 1825 days post treatment

Outcome Measure Data

Analysis Population Description

Subjects treated or intended to treat with the test device

Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Measure Participants	160
Number [Percentage of participants]	0 0%

Adverse Events

Time Frame	60 months
Arm/Group Title	Valiant Thoracic Stent Graft System
Arm/Group Description	160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device. There were no other arms for this study.
All Cause Mortality
	Valiant Thoracic Stent Graft System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Valiant Thoracic Stent Graft System
	Affected / at Risk (%)	# Events
Total	135/160 (84.4%)
Blood and lymphatic system disorders
Anaemia	6/160 (3.8%)	7
Anaemia macrocytic	1/160 (0.6%)	1
Anaemia of chronic disease	1/160 (0.6%)	1
Coagulopathy	1/160 (0.6%)	1
Disseminated intravascular coagulation	1/160 (0.6%)	1
Heparin-induced thrombocytopenia	2/160 (1.3%)	2
Normochromic normocytic anaemia	1/160 (0.6%)	1
Thrombocytopenia	1/160 (0.6%)	1
Cardiac disorders
Angina pectoris	7/160 (4.4%)	7
Angina unstable	3/160 (1.9%)	4
Aortic valve stenosis	1/160 (0.6%)	1
Atrial fibrillation	8/160 (5%)	10
Cardiac arrest	3/160 (1.9%)	3
Cardiac failure congestive	14/160 (8.8%)	16
Cardio-respiratory arrest	3/160 (1.9%)	3
Cardiogenic shock	1/160 (0.6%)	1
Coronary artery disease	3/160 (1.9%)	3
Coronary artery stenosis	1/160 (0.6%)	1
Endocardial fibroelastosis	1/160 (0.6%)	1
Hypertensive emergency	1/160 (0.6%)	1
Ischaemic cardiomyopathy	2/160 (1.3%)	2
Myocardial infarction	12/160 (7.5%)	14
Supraventricular tachycardia	1/160 (0.6%)	1
Ventricular tachyarrhythmia	1/160 (0.6%)	1
Ventricular tachycardia	1/160 (0.6%)	1
Gastrointestinal disorders
Abdominal discomfort	3/160 (1.9%)	3
Abdominal hernia	1/160 (0.6%)	1
Abdominal pain	6/160 (3.8%)	6
Abdominal pain upper	3/160 (1.9%)	3
Duodenal ulcer	1/160 (0.6%)	1
Dysphagia	3/160 (1.9%)	3
Faeces discoloured	1/160 (0.6%)	1
Gastritis	2/160 (1.3%)	2
Gastrointestinal haemorrhage	12/160 (7.5%)	14
Ileus	2/160 (1.3%)	2
Intestinal ischaemia	2/160 (1.3%)	2
Intestinal obstruction	3/160 (1.9%)	3
Intestinal perforation	1/160 (0.6%)	1
Nausea	1/160 (0.6%)	1
Pancreatitis	1/160 (0.6%)	1
Rectal haemorrhage	1/160 (0.6%)	1
Retroperitoneal haemorrhage	2/160 (1.3%)	2
Varices oesophageal	1/160 (0.6%)	1
General disorders
Asthenia	1/160 (0.6%)	1
Chest pain	10/160 (6.3%)	16
Complication of device insertion	1/160 (0.6%)	1
Death	1/160 (0.6%)	1
Device deployment issue	2/160 (1.3%)	2
Generalised oedema	1/160 (0.6%)	1
Impaired healing	1/160 (0.6%)	1
Infusion site extravasation	1/160 (0.6%)	1
Medical device complication	1/160 (0.6%)	1
Multi-organ failure	2/160 (1.3%)	2
Stent-graft endoleak	13/160 (8.1%)	17
Vessel puncture site haematoma	4/160 (2.5%)	4
Hepatobiliary disorders
Cholecystitis chronic	1/160 (0.6%)	1
Cholelithiasis	1/160 (0.6%)	1
Infections and infestations
Clostridial infection	1/160 (0.6%)	1
Device related infection	1/160 (0.6%)	1
Diverticulitis	2/160 (1.3%)	3
Gangrene	1/160 (0.6%)	1
Gastroenteritis viral	1/160 (0.6%)	1
Groin abscess	1/160 (0.6%)	1
Herpes zoster	1/160 (0.6%)	1
Pneumonia	12/160 (7.5%)	15
Pneumonia bacterial	1/160 (0.6%)	1
Pneumonia herpes viral	1/160 (0.6%)	1
Sepsis	9/160 (5.6%)	11
Systemic candida	1/160 (0.6%)	1
Urinary tract infection	3/160 (1.9%)	3
Urinary tract infection pseudomonal	1/160 (0.6%)	2
Wound infection	1/160 (0.6%)	1
Wound infection staphylococcal	2/160 (1.3%)	2
Injury, poisoning and procedural complications
Abdominal wound dehiscence	1/160 (0.6%)	1
Ankle fracture	1/160 (0.6%)	1
Aortic rupture	2/160 (1.3%)	2
Arterial injury	8/160 (5%)	8
Asbestosis	1/160 (0.6%)	1
Eyeball rupture	1/160 (0.6%)	1
Fall	1/160 (0.6%)	1
Hip fracture	3/160 (1.9%)	3
Joint dislocation	1/160 (0.6%)	1
Laceration	1/160 (0.6%)	1
Open wound	1/160 (0.6%)	1
Operative haemorrhage	6/160 (3.8%)	6
Overdose	1/160 (0.6%)	1
Patella fracture	1/160 (0.6%)	1
Post lumbar puncture syndrome	1/160 (0.6%)	1
Post procedural haemorrhage	3/160 (1.9%)	3
Road traffic accident	1/160 (0.6%)	1
Seroma	1/160 (0.6%)	1
Subdural haematoma	1/160 (0.6%)	1
Traumatic haematoma	1/160 (0.6%)	1
Vascular pseudoaneurysm	1/160 (0.6%)	1
Vascular pseudoaneurysm ruptured	1/160 (0.6%)	1
Investigations
Blood lactic acid increased	1/160 (0.6%)	1
Oxygen saturation decreased	1/160 (0.6%)	1
Metabolism and nutrition disorders
Dehydration	2/160 (1.3%)	2
Failure to thrive	1/160 (0.6%)	1
Fluid overload	1/160 (0.6%)	2
Hyperkalaemia	1/160 (0.6%)	1
Hypovolaemia	1/160 (0.6%)	1
Malnutrition	3/160 (1.9%)	3
Metabolic acidosis	3/160 (1.9%)	3
Musculoskeletal and connective tissue disorders
Arthralgia	1/160 (0.6%)	1
Arthropathy	1/160 (0.6%)	1
Back pain	7/160 (4.4%)	7
Gouty arthritis	1/160 (0.6%)	1
Lumbar spinal stenosis	1/160 (0.6%)	1
Osteoarthritis	1/160 (0.6%)	1
Soft tissue necrosis	1/160 (0.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	3/160 (1.9%)	3
Brain neoplasm	1/160 (0.6%)	1
Chronic myeloid leukaemia	1/160 (0.6%)	1
Colon cancer	1/160 (0.6%)	1
Gastric cancer	1/160 (0.6%)	1
Leukaemia	1/160 (0.6%)	1
Lung neoplasm	2/160 (1.3%)	2
Lung neoplasm malignant	5/160 (3.1%)	5
Multiple myeloma	1/160 (0.6%)	1
Myelodysplastic syndrome	2/160 (1.3%)	2
Neoplasm malignant	1/160 (0.6%)	1
Non-small cell lung cancer stage IIIB	1/160 (0.6%)	1
Prostate cancer	2/160 (1.3%)	2
Small cell lung cancer stage unspecified	1/160 (0.6%)	1
Nervous system disorders
Cerebrovascular accident	6/160 (3.8%)	7
Convulsion	2/160 (1.3%)	2
Encephalopathy	1/160 (0.6%)	1
Haemorrhage intracranial	4/160 (2.5%)	4
Headache	1/160 (0.6%)	1
Hemiparesis	1/160 (0.6%)	1
Hypoxic-ischaemic encephalopathy	1/160 (0.6%)	1
Neuropathy peripheral	4/160 (2.5%)	4
Paraparesis	1/160 (0.6%)	1
Paraplegia	1/160 (0.6%)	1
Presyncope	1/160 (0.6%)	1
Spinal cord ischaemia	2/160 (1.3%)	2
Syncope	2/160 (1.3%)	2
Transient ischaemic attack	5/160 (3.1%)	5
Vocal cord paralysis	1/160 (0.6%)	1
Psychiatric disorders
Mental status changes	5/160 (3.1%)	5
Panic disorder	1/160 (0.6%)	1
Renal and urinary disorders
Haematuria	1/160 (0.6%)	1
Hydronephrosis	1/160 (0.6%)	1
Renal failure	4/160 (2.5%)	5
Renal failure acute	7/160 (4.4%)	7
Renal failure chronic	1/160 (0.6%)	1
Urinary retention	2/160 (1.3%)	2
Reproductive system and breast disorders
Prostatomegaly	1/160 (0.6%)	1
Pulmonary embolism	5/160 (3.1%)	5
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome	5/160 (3.1%)	5
Asthma	1/160 (0.6%)	1
Atelectasis	1/160 (0.6%)	1
Bronchitis	1/160 (0.6%)	1
Choking	1/160 (0.6%)	1
Chronic obstructive pulmonary disease	6/160 (3.8%)	8
Dyspnoea	1/160 (0.6%)	1
Dyspnoea exertional	3/160 (1.9%)	3
Haemoptysis	3/160 (1.9%)	3
Haemothorax	1/160 (0.6%)	1
Pleural effusion	8/160 (5%)	9
Pneumonia aspiration	1/160 (0.6%)	1
Pulmonary haemorrhage	1/160 (0.6%)	1
Pulmonary oedema	5/160 (3.1%)	5
Respiratory failure	16/160 (10%)	19
Tachypnoea	1/160 (0.6%)	1
Skin and subcutaneous tissue disorders
Decubitus ulcer	2/160 (1.3%)	2
Surgical and medical procedures
Bladder catheter replacement	1/160 (0.6%)	1
Cholecystectomy	1/160 (0.6%)	1
Colostomy closure	2/160 (1.3%)	2
Coronary angioplasty	1/160 (0.6%)	1
Hernia repair	1/160 (0.6%)	1
Vascular disorders
Aortic aneurysm	22/160 (13.8%)	26
Aortic aneurysm rupture	2/160 (1.3%)	2
Aortic dissection	5/160 (3.1%)	5
Arterial occlusive disease	3/160 (1.9%)	3
Arteriosclerosis	1/160 (0.6%)	1
Deep vein thrombosis	4/160 (2.5%)	4
Femoral arterial stenosis	1/160 (0.6%)	1
Haematoma	2/160 (1.3%)	2
Hypertension	1/160 (0.6%)	1
Hypotension	4/160 (2.5%)	5
Lymphocele	1/160 (0.6%)	1
Peripheral artery aneurysm	1/160 (0.6%)	1
Peripheral artery dissection	1/160 (0.6%)	1
Peripheral embolism	1/160 (0.6%)	1
Peripheral ischaemia	4/160 (2.5%)	4
Poor peripheral circulation	1/160 (0.6%)	1
Splenic embolism	1/160 (0.6%)	1
Thrombosis	1/160 (0.6%)	1
arteriovenous fistula	1/160 (0.6%)	1
Other (Not Including Serious) Adverse Events
	Valiant Thoracic Stent Graft System
	Affected / at Risk (%)	# Events
Total	160/160 (100%)
Cardiac disorders
Atrial fibrillation	22/160 (13.8%)	24
Gastrointestinal disorders
Abdominal Pain	8/160 (5%)	10
Nausea	11/160 (6.9%)	11
General disorders
Chest pain	21/160 (13.1%)	28
Oedema peripheral	9/160 (5.6%)	9
Pyrexia	17/160 (10.6%)	17
Stent-graft endoleak	32/160 (20%)	37
Vessel puncture site haematoma	10/160 (6.3%)	10
Infections and infestations
Pneumonia	8/160 (5%)	8
Urinary tract infection	13/160 (8.1%)	16
Injury, poisoning and procedural complications
Post procedural haemorrhage	8/160 (5%)	8
Investigations
Haematocrit decreased	9/160 (5.6%)	9
Musculoskeletal and connective tissue disorders
Back Pain	32/160 (20%)	35
Nervous system disorders
Headache	8/160 (5%)	8
Psychiatric disorders
Mental status changes	19/160 (11.9%)	21
Renal and urinary disorders
Renal failure	9/160 (5.6%)	9
Respiratory, thoracic and mediastinal disorders
Atelectasis	9/160 (5.6%)	9
Dyspnoea	10/160 (6.3%)	10
Pleural effusion	17/160 (10.6%)	17
Vascular disorders
Aortic aneurysm	14/160 (8.8%)	17
Hypertension	15/160 (9.4%)	15

Limitations/Caveats

Adverse Events and Serious Adverse Events listed in ClinicalTrials.gov were re-coded, using MedDRA 13.1. To do so, events were reclassified. As a result, data in listings may not match those in Clinical Update reports, SSEDs, or Instructions for Use.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Principal Investigator (PI) and institution agree not to publish the results of the study until after the earliest of the following: a)conclusion of the study, b)the early termination of the study, c)at discretion and approval of the sponsor, or d)after sponsor confirms there will be no multicenter study publication, whichever occurs first. PI and institution further agree to submit to sponsor copies of any proposed publication or public presentation at least sixty days before dissemination.