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Valor II: The Valiant Thoracic Stent Graft System Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00413231
Recruitment Status : Completed
First Posted : December 19, 2006
Results First Posted : April 5, 2012
Last Update Posted : December 30, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Thoracic Aortic Aneurysm
Intervention Device: Valiant Thoracic Stent Graft System
Enrollment 160
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Valiant Thoracic Stent Graft System
Hide 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
Reason Not Completed
Death             5
Intend to treat, but not implanted             3
Period Title: 30-day to 365-day Post Treatment
Started 152
Completed 139
Not Completed 13
Reason Not Completed
Death             13
Period Title: 365-day to 60-month Post Treatment
Started 139
Completed 93
Not Completed 46
Reason Not Completed
Death             36
Withdrawal by Subject             5
Lost to Follow-up             4
Exited after surgical conversion             1
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Baseline Participants 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  16.3%
>=65 years
134
  83.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants
72.2  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants
Female
65
  40.6%
Male
95
  59.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 160 participants
160
1.Primary Outcome
Title Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
94.8
(90.9 to 97.1)
2.Primary Outcome
Title Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
97.4
(93.4 to 100)
3.Primary Outcome
Title Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of Participants
12.6
(7.3 to 17.9)
4.Secondary Outcome
Title Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide 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).

Overall Number of Participants Analyzed 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
96.3
(92 to 98.6)
5.Secondary Outcome
Title Percentage of Participants That Experienced Perioperative Mortality
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
3.1
(1 to 7.1)
6.Secondary Outcome
Title Percentage of Participants That Experienced Paraplegia
Hide Description Percentage of subjects that experienced paraplegia within 30 days post treatment
Time Frame Within 30 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.6
(0 to 3.4)
7.Secondary Outcome
Title Percentage of Participants That Experienced Paraparesis
Hide Description Percentage of subjects that experienced paraparesis within 30 days post treatment
Time Frame Within 30 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
1.9
(0.4 to 5.4)
8.Secondary Outcome
Title Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0.6
(0 to 2.5)
9.Secondary Outcome
Title Percentage of Participants That Experienced One or More Major Adverse Events
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
38.1
(30.6 to 46.1)
10.Secondary Outcome
Title Percentage of Participants That Experienced Aneurysm-related Mortality
Hide Description Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment
Time Frame Within 12 months post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
3.3
(1.1 to 7.6)
11.Secondary Outcome
Title Percentage of Participants That Experience Aneurysm Rupture
Hide Description Percentage of subjects that experience aneurysm rupture within 12 months post treatment
Time Frame Within 12 months post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 154
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0
(0 to 2.4)
12.Secondary Outcome
Title Percentage of Participants That Experienced Conversion to Open Surgical Repair
Hide Description Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment
Time Frame Within 12 months post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 154
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0
(0 to 2.4)
13.Secondary Outcome
Title Percentage of Participants That Experienced Endoleak(s)
Hide Description Percentage of subjects that experienced endoleak(s) of any type at 12 months
Time Frame At 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
13
(7.1 to 21.2)
14.Secondary Outcome
Title Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 143
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0
(0 to 2.5)
15.Secondary Outcome
Title Percentage of Participants That Experienced Stent Graft Migration
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 105
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
2.9
(0.6 to 8.1)
16.Secondary Outcome
Title Percentage of Participants That Experience Loss of Stent Graft Patency
Hide Description Percentage of subjects that experience loss of stent graft patency within 12 months post treatment
Time Frame Within 12 months post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 100
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
0
(0 to 3.6)
17.Secondary Outcome
Title Percentage of Participants That Experienced One or More Major Adverse Events
Hide Description Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment
Time Frame Within 12 months post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 154
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
48.7
(40.6 to 56.9)
18.Secondary Outcome
Title Percentage of Participants That Died (All-cause Mortality)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Percentage of participants
33.8
19.Secondary Outcome
Title Percentage of Participants That Experienced Aneurysm-related Mortality
Hide Description Percentage of subjects that experienced aneurysm-related within five years post implant
Time Frame 0 through 1825 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Percentage of participants
5
20.Secondary Outcome
Title Percentage of Participants That Experienced Aneurysm Ruptures
Hide Description Percentage of subjects that experienced aneurysm ruptures within five years post implant
Time Frame 0 through 1825 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Percentage of participants
1.3
21.Secondary Outcome
Title Percentage of Participants That Experienced Conversions to Open Surgical Repair
Hide Description Percentage of subjects that experienced conversions to open surgical repair within five years post implant
Time Frame 0 through 1825 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Percentage of participants
0.6
22.Secondary Outcome
Title Percentage of Participants That Experienced Type I Endoleaks
Hide Description Percentage of subjects that experienced type I endoleaks within five years post implant
Time Frame 0 through 1825 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Percentage of participants
8.1
23.Secondary Outcome
Title Percentage of Participants That Experienced Type III Endoleaks
Hide Description Percentage of subjects that experienced type III endoleaks within five years post implant
Time Frame 0 through 1825 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Percentage of participants
0.6
24.Secondary Outcome
Title Percentage of Participants That Experienced Type IV Endoleaks
Hide Description Percentage of subjects that experienced type IV endoleaks within five years post implant
Time Frame 0 through 1825 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Percentage of participants
1.3
25.Secondary Outcome
Title Percentage of Participants That Experienced Secondary Endovascular Procedures
Hide Description Percentage of subjects that experienced secondary endovascular procedures within five years post implant
Time Frame 0 through 1825 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Percentage of participants
6.9
26.Secondary Outcome
Title Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Percentage of participants
0
27.Secondary Outcome
Title Percentage of Participants That Experienced Loss of Stent Graft Patency
Hide Description Percentage of subjects that experienced loss of stent graft patency within five years post implant
Time Frame 0 through 1825 days post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects treated or intended to treat with the test device
Arm/Group Title Valiant Thoracic Stent Graft System
Hide Arm/Group Description:
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Percentage of participants
0
Time Frame 60 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Valiant Thoracic Stent Graft System
Hide 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 (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Valiant Thoracic Stent Graft System
Affected / at Risk (%) # Events
Total   135/160 (84.38%)    
Blood and lymphatic system disorders   
Anaemia  1  6/160 (3.75%)  7
Anaemia macrocytic  1  1/160 (0.63%)  1
Anaemia of chronic disease  1  1/160 (0.63%)  1
Coagulopathy  1  1/160 (0.63%)  1
Disseminated intravascular coagulation  1  1/160 (0.63%)  1
Heparin-induced thrombocytopenia  1  2/160 (1.25%)  2
Normochromic normocytic anaemia  1  1/160 (0.63%)  1
Thrombocytopenia  1  1/160 (0.63%)  1
Cardiac disorders   
Angina pectoris  1  7/160 (4.38%)  7
Angina unstable  1  3/160 (1.88%)  4
Aortic valve stenosis  1  1/160 (0.63%)  1
Atrial fibrillation  1  8/160 (5.00%)  10
Cardiac arrest  1  3/160 (1.88%)  3
Cardiac failure congestive  1  14/160 (8.75%)  16
Cardio-respiratory arrest  1  3/160 (1.88%)  3
Cardiogenic shock  1  1/160 (0.63%)  1
Coronary artery disease  1  3/160 (1.88%)  3
Coronary artery stenosis  1  1/160 (0.63%)  1
Endocardial fibroelastosis  1  1/160 (0.63%)  1
Hypertensive emergency  1  1/160 (0.63%)  1
Ischaemic cardiomyopathy  1  2/160 (1.25%)  2
Myocardial infarction  1  12/160 (7.50%)  14
Supraventricular tachycardia  1  1/160 (0.63%)  1
Ventricular tachyarrhythmia  1  1/160 (0.63%)  1
Ventricular tachycardia  1  1/160 (0.63%)  1
Gastrointestinal disorders   
Abdominal discomfort  1  3/160 (1.88%)  3
Abdominal hernia  1  1/160 (0.63%)  1
Abdominal pain  1  6/160 (3.75%)  6
Abdominal pain upper  1  3/160 (1.88%)  3
Duodenal ulcer  1  1/160 (0.63%)  1
Dysphagia  1  3/160 (1.88%)  3
Faeces discoloured  1  1/160 (0.63%)  1
Gastritis  1  2/160 (1.25%)  2
Gastrointestinal haemorrhage  1  12/160 (7.50%)  14
Ileus  1  2/160 (1.25%)  2
Intestinal ischaemia  1  2/160 (1.25%)  2
Intestinal obstruction  1  3/160 (1.88%)  3
Intestinal perforation  1  1/160 (0.63%)  1
Nausea  1  1/160 (0.63%)  1
Pancreatitis  1  1/160 (0.63%)  1
Rectal haemorrhage  1  1/160 (0.63%)  1
Retroperitoneal haemorrhage  1  2/160 (1.25%)  2
Varices oesophageal  1  1/160 (0.63%)  1
General disorders   
Asthenia  1  1/160 (0.63%)  1
Chest pain  1  10/160 (6.25%)  16
Complication of device insertion  1  1/160 (0.63%)  1
Death  1 [1]  1/160 (0.63%)  1
Device deployment issue  1  2/160 (1.25%)  2
Generalised oedema  1  1/160 (0.63%)  1
Impaired healing  1  1/160 (0.63%)  1
Infusion site extravasation  1  1/160 (0.63%)  1
Medical device complication  1 [2]  1/160 (0.63%)  1
Multi-organ failure  1  2/160 (1.25%)  2
Stent-graft endoleak  1 [3]  13/160 (8.13%)  17
Vessel puncture site haematoma  1  4/160 (2.50%)  4
Hepatobiliary disorders   
Cholecystitis chronic  1  1/160 (0.63%)  1
Cholelithiasis  1  1/160 (0.63%)  1
Infections and infestations   
Clostridial infection  1  1/160 (0.63%)  1
Device related infection  1  1/160 (0.63%)  1
Diverticulitis  1  2/160 (1.25%)  3
Gangrene  1  1/160 (0.63%)  1
Gastroenteritis viral  1  1/160 (0.63%)  1
Groin abscess  1  1/160 (0.63%)  1
Herpes zoster  1  1/160 (0.63%)  1
Pneumonia  1  12/160 (7.50%)  15
Pneumonia bacterial  1  1/160 (0.63%)  1
Pneumonia herpes viral  1  1/160 (0.63%)  1
Sepsis  1  9/160 (5.63%)  11
Systemic candida  1  1/160 (0.63%)  1
Urinary tract infection  1  3/160 (1.88%)  3
Urinary tract infection pseudomonal  1  1/160 (0.63%)  2
Wound infection  1  1/160 (0.63%)  1
Wound infection staphylococcal  1  2/160 (1.25%)  2
Injury, poisoning and procedural complications   
Abdominal wound dehiscence  1  1/160 (0.63%)  1
Ankle fracture  1  1/160 (0.63%)  1
Aortic rupture  1  2/160 (1.25%)  2
Arterial injury  1  8/160 (5.00%)  8
Asbestosis  1  1/160 (0.63%)  1
Eyeball rupture  1  1/160 (0.63%)  1
Fall  1  1/160 (0.63%)  1
Hip fracture  1  3/160 (1.88%)  3
Joint dislocation  1  1/160 (0.63%)  1
Laceration  1  1/160 (0.63%)  1
Open wound  1  1/160 (0.63%)  1
Operative haemorrhage  1  6/160 (3.75%)  6
Overdose  1  1/160 (0.63%)  1
Patella fracture  1  1/160 (0.63%)  1
Post lumbar puncture syndrome  1  1/160 (0.63%)  1
Post procedural haemorrhage  1  3/160 (1.88%)  3
Road traffic accident  1  1/160 (0.63%)  1
Seroma  1  1/160 (0.63%)  1
Subdural haematoma  1  1/160 (0.63%)  1
Traumatic haematoma  1  1/160 (0.63%)  1
Vascular pseudoaneurysm  1  1/160 (0.63%)  1
Vascular pseudoaneurysm ruptured  1  1/160 (0.63%)  1
Investigations   
Blood lactic acid increased  1  1/160 (0.63%)  1
Oxygen saturation decreased  1  1/160 (0.63%)  1
Metabolism and nutrition disorders   
Dehydration  1  2/160 (1.25%)  2
Failure to thrive  1  1/160 (0.63%)  1
Fluid overload  1  1/160 (0.63%)  2
Hyperkalaemia  1  1/160 (0.63%)  1
Hypovolaemia  1  1/160 (0.63%)  1
Malnutrition  1  3/160 (1.88%)  3
Metabolic acidosis  1  3/160 (1.88%)  3
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/160 (0.63%)  1
Arthropathy  1  1/160 (0.63%)  1
Back pain  1  7/160 (4.38%)  7
Gouty arthritis  1  1/160 (0.63%)  1
Lumbar spinal stenosis  1  1/160 (0.63%)  1
Osteoarthritis  1  1/160 (0.63%)  1
Soft tissue necrosis  1  1/160 (0.63%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer  1  3/160 (1.88%)  3
Brain neoplasm  1  1/160 (0.63%)  1
Chronic myeloid leukaemia  1  1/160 (0.63%)  1
Colon cancer  1  1/160 (0.63%)  1
Gastric cancer  1  1/160 (0.63%)  1
Leukaemia  1  1/160 (0.63%)  1
Lung neoplasm  1  2/160 (1.25%)  2
Lung neoplasm malignant  1  5/160 (3.13%)  5
Multiple myeloma  1  1/160 (0.63%)  1
Myelodysplastic syndrome  1  2/160 (1.25%)  2
Neoplasm malignant  1  1/160 (0.63%)  1
Non-small cell lung cancer stage IIIB  1  1/160 (0.63%)  1
Prostate cancer  1  2/160 (1.25%)  2
Small cell lung cancer stage unspecified  1  1/160 (0.63%)  1
Nervous system disorders   
Cerebrovascular accident  1  6/160 (3.75%)  7
Convulsion  1  2/160 (1.25%)  2
Encephalopathy  1  1/160 (0.63%)  1
Haemorrhage intracranial  1  4/160 (2.50%)  4
Headache  1  1/160 (0.63%)  1
Hemiparesis  1  1/160 (0.63%)  1
Hypoxic-ischaemic encephalopathy  1  1/160 (0.63%)  1
Neuropathy peripheral  1  4/160 (2.50%)  4
Paraparesis  1  1/160 (0.63%)  1
Paraplegia  1  1/160 (0.63%)  1
Presyncope  1  1/160 (0.63%)  1
Spinal cord ischaemia  1  2/160 (1.25%)  2
Syncope  1  2/160 (1.25%)  2
Transient ischaemic attack  1  5/160 (3.13%)  5
Vocal cord paralysis  1  1/160 (0.63%)  1
Psychiatric disorders   
Mental status changes  1 [4]  5/160 (3.13%)  5
Panic disorder  1  1/160 (0.63%)  1
Renal and urinary disorders   
Haematuria  1  1/160 (0.63%)  1
Hydronephrosis  1  1/160 (0.63%)  1
Renal failure  1  4/160 (2.50%)  5
Renal failure acute  1  7/160 (4.38%)  7
Renal failure chronic  1  1/160 (0.63%)  1
Urinary retention  1  2/160 (1.25%)  2
Reproductive system and breast disorders   
Prostatomegaly  1  1/160 (0.63%)  1
Pulmonary embolism  1  5/160 (3.13%)  5
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome  1  5/160 (3.13%)  5
Asthma  1  1/160 (0.63%)  1
Atelectasis  1  1/160 (0.63%)  1
Bronchitis  1  1/160 (0.63%)  1
Choking  1  1/160 (0.63%)  1
Chronic obstructive pulmonary disease  1  6/160 (3.75%)  8
Dyspnoea  1  1/160 (0.63%)  1
Dyspnoea exertional  1  3/160 (1.88%)  3
Haemoptysis  1  3/160 (1.88%)  3
Haemothorax  1  1/160 (0.63%)  1
Pleural effusion  1  8/160 (5.00%)  9
Pneumonia aspiration  1  1/160 (0.63%)  1
Pulmonary haemorrhage  1  1/160 (0.63%)  1
Pulmonary oedema  1  5/160 (3.13%)  5
Respiratory failure  1  16/160 (10.00%)  19
Tachypnoea  1  1/160 (0.63%)  1
Skin and subcutaneous tissue disorders   
Decubitus ulcer  1  2/160 (1.25%)  2
Surgical and medical procedures   
Bladder catheter replacement  1  1/160 (0.63%)  1
Cholecystectomy  1  1/160 (0.63%)  1
Colostomy closure  1  2/160 (1.25%)  2
Coronary angioplasty  1  1/160 (0.63%)  1
Hernia repair  1  1/160 (0.63%)  1
Vascular disorders   
Aortic aneurysm  1 [5]  22/160 (13.75%)  26
Aortic aneurysm rupture  1  2/160 (1.25%)  2
Aortic dissection  1  5/160 (3.13%)  5
Arterial occlusive disease  1  3/160 (1.88%)  3
Arteriosclerosis  1  1/160 (0.63%)  1
Deep vein thrombosis  1  4/160 (2.50%)  4
Femoral arterial stenosis  1  1/160 (0.63%)  1
Haematoma  1  2/160 (1.25%)  2
Hypertension  1  1/160 (0.63%)  1
Hypotension  1  4/160 (2.50%)  5
Lymphocele  1  1/160 (0.63%)  1
Peripheral artery aneurysm  1  1/160 (0.63%)  1
Peripheral artery dissection  1  1/160 (0.63%)  1
Peripheral embolism  1  1/160 (0.63%)  1
Peripheral ischaemia  1  4/160 (2.50%)  4
Poor peripheral circulation  1  1/160 (0.63%)  1
Splenic embolism  1  1/160 (0.63%)  1
Thrombosis  1  1/160 (0.63%)  1
arteriovenous fistula  1  1/160 (0.63%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
[1]
Unknown cause of death. Overall in the study, there were 54 deaths (46 not related to the TAA; 8 related to the TAA). However, this death could not be classified any further, as site was unable to obtain any information associated to it.
[2]
Right prosthetic knee infection
[3]
TAA endoleaks: Type I, 9 events; Type II, 3; Type V/Unknown, 3. AAA endoleaks: 2 events
[4]
E.g., Confusion, aphasia, and disorientation
[5]
Includes non-treated aneurysm, such as abdominal aneurysms, and aneurysm expansion of treated aneurysms
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Valiant Thoracic Stent Graft System
Affected / at Risk (%) # Events
Total   160/160 (100.00%)    
Cardiac disorders   
Atrial fibrillation  1  22/160 (13.75%)  24
Gastrointestinal disorders   
Abdominal Pain  1  8/160 (5.00%)  10
Nausea  1  11/160 (6.88%)  11
General disorders   
Chest pain  1  21/160 (13.13%)  28
Oedema peripheral  1  9/160 (5.63%)  9
Pyrexia  1  17/160 (10.63%)  17
Stent-graft endoleak  1 [1]  32/160 (20.00%)  37
Vessel puncture site haematoma  1  10/160 (6.25%)  10
Infections and infestations   
Pneumonia  1  8/160 (5.00%)  8
Urinary tract infection  1  13/160 (8.13%)  16
Injury, poisoning and procedural complications   
Post procedural haemorrhage  1  8/160 (5.00%)  8
Investigations   
Haematocrit decreased  1  9/160 (5.63%)  9
Musculoskeletal and connective tissue disorders   
Back Pain  1  32/160 (20.00%)  35
Nervous system disorders   
Headache  1  8/160 (5.00%)  8
Psychiatric disorders   
Mental status changes  1 [2]  19/160 (11.88%)  21
Renal and urinary disorders   
Renal failure  1  9/160 (5.63%)  9
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  9/160 (5.63%)  9
Dyspnoea  1  10/160 (6.25%)  10
Pleural effusion  1  17/160 (10.63%)  17
Vascular disorders   
Aortic aneurysm  1 [3]  14/160 (8.75%)  17
Hypertension  1  15/160 (9.38%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
[1]
TAA endoleaks: Type I, 6 events; Type II, 20; Type III, 1; Type IV, 2; Type V/Unknown, 5. AAA endoleaks: 3 events.
[2]
E.g. Confusion, worsening memory, and anxiety
[3]
Includes non-treated aneurysm, such as abdominal aneurysms, and aneurysm expansion of treated aneurysms
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: PJ Belmont, Clinical Research Specialist
Organization: Medtronic Vascular, Inc.
Phone: 707-480-3025
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00413231     History of Changes
Other Study ID Numbers: Investigational Plan #078
First Submitted: December 15, 2006
First Posted: December 19, 2006
Results First Submitted: December 23, 2011
Results First Posted: April 5, 2012
Last Update Posted: December 30, 2015