Trial Outcomes & Findings for Valor II: The Valiant Thoracic Stent Graft System Clinical Study (NCT NCT00413231)
NCT ID: NCT00413231
Last Updated: 2021-11-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
0 through 1825 days post treatment
Results posted on
2021-11-03
Participant Flow
Participant milestones
| Measure |
Valiant Thoracic Stent Graft System
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
0 to 30-day Post Treatment
STARTED
|
160
|
|
0 to 30-day Post Treatment
COMPLETED
|
152
|
|
0 to 30-day Post Treatment
NOT COMPLETED
|
8
|
|
30-day to 365-day Post Treatment
STARTED
|
152
|
|
30-day to 365-day Post Treatment
COMPLETED
|
139
|
|
30-day to 365-day Post Treatment
NOT COMPLETED
|
13
|
|
365-day to 60-month Post Treatment
STARTED
|
139
|
|
365-day to 60-month Post Treatment
COMPLETED
|
93
|
|
365-day to 60-month Post Treatment
NOT COMPLETED
|
46
|
Reasons for withdrawal
| Measure |
Valiant Thoracic Stent Graft System
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
0 to 30-day Post Treatment
Death
|
5
|
|
0 to 30-day Post Treatment
Intend to treat, but not implanted
|
3
|
|
30-day to 365-day Post Treatment
Death
|
13
|
|
365-day to 60-month Post Treatment
Death
|
36
|
|
365-day to 60-month Post Treatment
Withdrawal by Subject
|
5
|
|
365-day to 60-month Post Treatment
Lost to Follow-up
|
4
|
|
365-day to 60-month Post Treatment
Exited after surgical conversion
|
1
|
Baseline Characteristics
Valor II: The Valiant Thoracic Stent Graft System Clinical Study
Baseline characteristics by cohort
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
134 Participants
n=5 Participants
|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
95 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
160 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 through 1825 days post treatmentPopulation: Subjects treated or intended to treat with the test device
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.
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
|
94.8 Percentage of participants
Interval 90.9 to 97.1
|
PRIMARY outcome
Timeframe: At 12-month post procedurePopulation: Subjects treated or intended to treat with the test device
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).
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)
|
97.4 Percentage of Participants
Interval 93.4 to 100.0
|
PRIMARY outcome
Timeframe: Within 12-months post treatmentPopulation: Subjects treated or intended to treat with the test device
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.
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >
|
12.6 Percentage of Participants
Interval 7.3 to 17.9
|
SECONDARY outcome
Timeframe: At implantPopulation: Subjects treated or intended to treat with the test device
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.
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant
|
96.3 Percentage of participants
Interval 92.0 to 98.6
|
SECONDARY outcome
Timeframe: Within 30 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Perioperative Mortality
|
3.1 Percentage of participants
Interval 1.0 to 7.1
|
SECONDARY outcome
Timeframe: Within 30 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced paraplegia within 30 days post treatment
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Paraplegia
|
0.6 Percentage of participants
Interval 0.0 to 3.4
|
SECONDARY outcome
Timeframe: Within 30 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced paraparesis within 30 days post treatment
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Paraparesis
|
1.9 Percentage of participants
Interval 0.4 to 5.4
|
SECONDARY outcome
Timeframe: Within 30 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge
|
0.6 Percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: Within 30 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced One or More Major Adverse Events
|
38.1 Percentage of participants
Interval 30.6 to 46.1
|
SECONDARY outcome
Timeframe: Within 12 months post treatmentPopulation: Subjects treated or intended to treat with the test device, excluding subjects exited before 12 months and implant failures
Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=151 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Aneurysm-related Mortality
|
3.3 Percentage of participants
Interval 1.1 to 7.6
|
SECONDARY outcome
Timeframe: Within 12 months post treatmentPopulation: Subjects treated or intended to treat with the test device excluding subjects that exited before 12 months
Percentage of subjects that experience aneurysm rupture within 12 months post treatment
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=154 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experience Aneurysm Rupture
|
0 Percentage of participants
Interval 0.0 to 2.4
|
SECONDARY outcome
Timeframe: Within 12 months post treatmentPopulation: Subjects treated or intended to treat with the test device excluding subjects exited before 12 months
Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=154 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Conversion to Open Surgical Repair
|
0 Percentage of participants
Interval 0.0 to 2.4
|
SECONDARY outcome
Timeframe: At 12 monthsPopulation: Subjects treated or intended to treat with the test device excluding subjects that did not have proper imaging to identify endoleaks
Percentage of subjects that experienced endoleak(s) of any type at 12 months
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=100 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Endoleak(s)
|
13 Percentage of participants
Interval 7.1 to 21.2
|
SECONDARY outcome
Timeframe: Between 30 days and 12 monthsPopulation: Subjects treated or intended to treat with the test device excluding censored subjects (those with no data within the time frame)
Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=143 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak
|
0 Percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: Within 12 months post treatmentPopulation: Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging
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.
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=105 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Stent Graft Migration
|
2.9 Percentage of participants
Interval 0.6 to 8.1
|
SECONDARY outcome
Timeframe: Within 12 months post treatmentPopulation: Subjects treated or intended to treat with the test device, excluding subjects that did not have proper imaging
Percentage of subjects that experience loss of stent graft patency within 12 months post treatment
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=100 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experience Loss of Stent Graft Patency
|
0 Percentage of participants
Interval 0.0 to 3.6
|
SECONDARY outcome
Timeframe: Within 12 months post treatmentPopulation: Subjects treated or intended to treat with the test device, excluded subjects that exited before 12 months
Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=154 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced One or More Major Adverse Events
|
48.7 Percentage of participants
Interval 40.6 to 56.9
|
SECONDARY outcome
Timeframe: 0 through 1825 days post treatmentPopulation: Subjects treated or intended to treat with the test device
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
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Died (All-cause Mortality)
|
33.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 through 1825 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced aneurysm-related within five years post implant
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Aneurysm-related Mortality
|
5 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 through 1825 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced aneurysm ruptures within five years post implant
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Aneurysm Ruptures
|
1.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 through 1825 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced conversions to open surgical repair within five years post implant
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Conversions to Open Surgical Repair
|
0.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 through 1825 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced type I endoleaks within five years post implant
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Type I Endoleaks
|
8.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 through 1825 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced type III endoleaks within five years post implant
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Type III Endoleaks
|
0.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 through 1825 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced type IV endoleaks within five years post implant
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Type IV Endoleaks
|
1.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 through 1825 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced secondary endovascular procedures within five years post implant
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Secondary Endovascular Procedures
|
6.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 through 1825 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 through 1825 days post treatmentPopulation: Subjects treated or intended to treat with the test device
Percentage of subjects that experienced loss of stent graft patency within five years post implant
Outcome measures
| Measure |
Valiant Thoracic Stent Graft System
n=160 Participants
Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
|
|---|---|
|
Percentage of Participants That Experienced Loss of Stent Graft Patency
|
0 Percentage of participants
|
Adverse Events
Valiant Thoracic Stent Graft System
Serious events: 135 serious events
Other events: 160 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Valiant Thoracic Stent Graft System
n=160 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
6/160 • Number of events 6 • 60 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.1%
5/160 • Number of events 5 • 60 months
|
|
Blood and lymphatic system disorders
Anaemia
|
3.8%
6/160 • Number of events 7 • 60 months
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Cardiac disorders
Angina pectoris
|
4.4%
7/160 • Number of events 7 • 60 months
|
|
Cardiac disorders
Angina unstable
|
1.9%
3/160 • Number of events 4 • 60 months
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Vascular disorders
Aortic aneurysm
|
13.8%
22/160 • Number of events 26 • 60 months
|
|
Vascular disorders
Aortic aneurysm rupture
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Vascular disorders
Aortic dissection
|
3.1%
5/160 • Number of events 5 • 60 months
|
|
Injury, poisoning and procedural complications
Aortic rupture
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Cardiac disorders
Aortic valve stenosis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Arterial injury
|
5.0%
8/160 • Number of events 8 • 60 months
|
|
Vascular disorders
Arterial occlusive disease
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Vascular disorders
Arteriosclerosis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
General disorders
Asthenia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
8/160 • Number of events 10 • 60 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
7/160 • Number of events 7 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Surgical and medical procedures
Bladder catheter replacement
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Investigations
Blood lactic acid increased
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Cardiac disorders
Cardiac arrest
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Cardiac disorders
Cardiac failure congestive
|
8.8%
14/160 • Number of events 16 • 60 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Cardiac disorders
Cardiogenic shock
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Nervous system disorders
Cerebrovascular accident
|
3.8%
6/160 • Number of events 7 • 60 months
|
|
General disorders
Chest pain
|
6.2%
10/160 • Number of events 16 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Surgical and medical procedures
Cholecystectomy
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.8%
6/160 • Number of events 8 • 60 months
|
|
Infections and infestations
Clostridial infection
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Surgical and medical procedures
Colostomy closure
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
General disorders
Complication of device insertion
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Nervous system disorders
Convulsion
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Cardiac disorders
Coronary artery stenosis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
General disorders
Death
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Vascular disorders
Deep vein thrombosis
|
2.5%
4/160 • Number of events 4 • 60 months
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
General disorders
Device deployment issue
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Infections and infestations
Device related infection
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Infections and infestations
Diverticulitis
|
1.2%
2/160 • Number of events 3 • 60 months
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Gastrointestinal disorders
Dysphagia
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Nervous system disorders
Encephalopathy
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Cardiac disorders
Endocardial fibroelastosis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Eyeball rupture
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Vascular disorders
Femoral arterial stenosis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.62%
1/160 • Number of events 2 • 60 months
|
|
Infections and infestations
Gangrene
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Gastrointestinal disorders
Gastritis
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Infections and infestations
Gastroenteritis viral
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
7.5%
12/160 • Number of events 14 • 60 months
|
|
General disorders
Generalised oedema
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Infections and infestations
Groin abscess
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Vascular disorders
Haematoma
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Renal and urinary disorders
Haematuria
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
2.5%
4/160 • Number of events 4 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Nervous system disorders
Headache
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Nervous system disorders
Hemiparesis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Surgical and medical procedures
Hernia repair
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Infections and infestations
Herpes zoster
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Vascular disorders
Hypertension
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Cardiac disorders
Hypertensive emergency
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Vascular disorders
Hypotension
|
2.5%
4/160 • Number of events 5 • 60 months
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Gastrointestinal disorders
Ileus
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
General disorders
Impaired healing
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
General disorders
Infusion site extravasation
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
3.1%
5/160 • Number of events 5 • 60 months
|
|
Vascular disorders
Lymphocele
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
General disorders
Medical device complication
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Psychiatric disorders
Mental status changes
|
3.1%
5/160 • Number of events 5 • 60 months
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
General disorders
Multi-organ failure
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Cardiac disorders
Myocardial infarction
|
7.5%
12/160 • Number of events 14 • 60 months
|
|
Gastrointestinal disorders
Nausea
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Nervous system disorders
Neuropathy peripheral
|
2.5%
4/160 • Number of events 4 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IIIB
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Open wound
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
3.8%
6/160 • Number of events 6 • 60 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Overdose
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Investigations
Oxygen saturation decreased
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Psychiatric disorders
Panic disorder
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Nervous system disorders
Paraparesis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Nervous system disorders
Paraplegia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Vascular disorders
Peripheral artery dissection
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Vascular disorders
Peripheral embolism
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Vascular disorders
Peripheral ischaemia
|
2.5%
4/160 • Number of events 4 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.0%
8/160 • Number of events 9 • 60 months
|
|
Infections and infestations
Pneumonia
|
7.5%
12/160 • Number of events 15 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Infections and infestations
Pneumonia bacterial
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Infections and infestations
Pneumonia herpes viral
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Vascular disorders
Poor peripheral circulation
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Nervous system disorders
Presyncope
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Reproductive system and breast disorders
Pulmonary embolism
|
3.1%
5/160 • Number of events 5 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
3.1%
5/160 • Number of events 5 • 60 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Renal and urinary disorders
Renal failure
|
2.5%
4/160 • Number of events 5 • 60 months
|
|
Renal and urinary disorders
Renal failure acute
|
4.4%
7/160 • Number of events 7 • 60 months
|
|
Renal and urinary disorders
Renal failure chronic
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
16/160 • Number of events 19 • 60 months
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Infections and infestations
Sepsis
|
5.6%
9/160 • Number of events 11 • 60 months
|
|
Injury, poisoning and procedural complications
Seroma
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Nervous system disorders
Spinal cord ischaemia
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Vascular disorders
Splenic embolism
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
General disorders
Stent-graft endoleak
|
8.1%
13/160 • Number of events 17 • 60 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Nervous system disorders
Syncope
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Infections and infestations
Systemic candida
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Vascular disorders
Thrombosis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Nervous system disorders
Transient ischaemic attack
|
3.1%
5/160 • Number of events 5 • 60 months
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Infections and infestations
Urinary tract infection
|
1.9%
3/160 • Number of events 3 • 60 months
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.62%
1/160 • Number of events 2 • 60 months
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
General disorders
Vessel puncture site haematoma
|
2.5%
4/160 • Number of events 4 • 60 months
|
|
Nervous system disorders
Vocal cord paralysis
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Infections and infestations
Wound infection
|
0.62%
1/160 • Number of events 1 • 60 months
|
|
Infections and infestations
Wound infection staphylococcal
|
1.2%
2/160 • Number of events 2 • 60 months
|
|
Vascular disorders
arteriovenous fistula
|
0.62%
1/160 • Number of events 1 • 60 months
|
Other adverse events
| Measure |
Valiant Thoracic Stent Graft System
n=160 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
8/160 • Number of events 10 • 60 months
|
|
Vascular disorders
Aortic aneurysm
|
8.8%
14/160 • Number of events 17 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.6%
9/160 • Number of events 9 • 60 months
|
|
Cardiac disorders
Atrial fibrillation
|
13.8%
22/160 • Number of events 24 • 60 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
20.0%
32/160 • Number of events 35 • 60 months
|
|
General disorders
Chest pain
|
13.1%
21/160 • Number of events 28 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
10/160 • Number of events 10 • 60 months
|
|
Investigations
Haematocrit decreased
|
5.6%
9/160 • Number of events 9 • 60 months
|
|
Nervous system disorders
Headache
|
5.0%
8/160 • Number of events 8 • 60 months
|
|
Vascular disorders
Hypertension
|
9.4%
15/160 • Number of events 15 • 60 months
|
|
Psychiatric disorders
Mental status changes
|
11.9%
19/160 • Number of events 21 • 60 months
|
|
Gastrointestinal disorders
Nausea
|
6.9%
11/160 • Number of events 11 • 60 months
|
|
General disorders
Oedema peripheral
|
5.6%
9/160 • Number of events 9 • 60 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.6%
17/160 • Number of events 17 • 60 months
|
|
Infections and infestations
Pneumonia
|
5.0%
8/160 • Number of events 8 • 60 months
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
5.0%
8/160 • Number of events 8 • 60 months
|
|
General disorders
Pyrexia
|
10.6%
17/160 • Number of events 17 • 60 months
|
|
Renal and urinary disorders
Renal failure
|
5.6%
9/160 • Number of events 9 • 60 months
|
|
General disorders
Stent-graft endoleak
|
20.0%
32/160 • Number of events 37 • 60 months
|
|
Infections and infestations
Urinary tract infection
|
8.1%
13/160 • Number of events 16 • 60 months
|
|
General disorders
Vessel puncture site haematoma
|
6.2%
10/160 • Number of events 10 • 60 months
|
Additional Information
PJ Belmont, Clinical Research Specialist
Medtronic Vascular, Inc.
Phone: 707-480-3025
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER