Trial Outcomes & Findings for Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms (NCT NCT03246126)
NCT ID: NCT03246126
Last Updated: 2024-04-10
Results Overview
Freedom from MAE is defined as the number of participants who have not experienced a major adverse event (including death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke) at 30 days.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Up to Day 30
Results posted on
2024-04-10
Participant Flow
17 individuals were enrolled in the study; however, 7 of these individuals did not start the study. Thus, the total number of participants who started the study is n=10.
Participant milestones
| Measure |
Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms
Baseline characteristics by cohort
| Measure |
Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=5 Participants
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=5 Participants
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.6 years
STANDARD_DEVIATION 7 • n=5 Participants
|
67.6 years
STANDARD_DEVIATION 15.6 • n=7 Participants
|
70.1 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30Freedom from MAE is defined as the number of participants who have not experienced a major adverse event (including death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke) at 30 days.
Outcome measures
| Measure |
Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=5 Participants
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=5 Participants
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
|---|---|---|
|
Freedom From Major Adverse Events (MAE) at Day 30
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to Year 1Technical success is defined as successful access of the aneurysm site and deployment of the Visceral Manifold investigational devices in intended locations.
Outcome measures
| Measure |
Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=5 Participants
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=4 Participants
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
|---|---|---|
|
Number of Participants Who Achieve Technical Success
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to Day 30Number of participants who have not experienced paraplegia at Day 30.
Outcome measures
| Measure |
Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=5 Participants
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=5 Participants
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
|---|---|---|
|
Freedom From Paraplegia at Day 30
|
3 Participants
|
4 Participants
|
Adverse Events
Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
Serious events: 5 serious events
Other events: 5 other events
Deaths: 4 deaths
Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=5 participants at risk
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=5 participants at risk
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Paraplegia
|
40.0%
2/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
40.0%
2/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
60.0%
3/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
60.0%
3/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Hepatobiliary disorders
Acute Cholecystitis
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Gastrointestinal disorders
Celiac Occlusion
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Clot (Mural Thrombus)
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Endoleak Type 1b
|
40.0%
2/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Endoleak Type 1c Left Renal Stent
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Endoleak Type 3 Left Renal
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Endoleak Type Iii
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Enlarging Aneurysmal Sac
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Infections and infestations
Exacerbation Of Respiratory Distress Due To Covid
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Extremities - Arterial Insufficiency Or Ischemia
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Left Femoral Artery Access Injury
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Loss Of Seal Of Left Common Iliac Artery (Cia)
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Infections and infestations
Methicillin-Sensitive Staphylococcus Aureus
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
General disorders
Multi Organ Failure
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Nervous system disorders
Neurogenic Bladder
|
40.0%
2/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Nervous system disorders
Neurogenic Bowel
|
40.0%
2/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
Paraparesis
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumoperitoneum
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumoperitoneum Ii
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Pulmonary Embolism
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Right Renal Stent Occlusion
|
40.0%
2/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Infections and infestations
Sepsis
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Infections and infestations
Septic Shock With Bacteremia
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Significant Intra-Operative Bleeding
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Infections and infestations
Staphlococcus Aureus Bacteremia Secondary To Sacral Ulcer
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Superior Mesenteric Artery Occlusion
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Gastrointestinal disorders
Upper GI Bleed
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Renal and urinary disorders
Urinary tract infection
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
Other adverse events
| Measure |
Primary Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=5 participants at risk
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
Expanded Use Arm: Treatment With Valiant Thoracoabdominal Stent Graft System
n=5 participants at risk
The implantation of the Valiant Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance.
Valiant™Thoracoabdominal Stent Graft System: The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
|
|---|---|---|
|
Cardiac disorders
1st Degree Atrioventricular (AV) Block
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Infections and infestations
Abscess Under Sacral Ulcer
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
40.0%
2/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Acute Subarachnoid Hemorrhage
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Blood and lymphatic system disorders
Anemia
|
80.0%
4/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
80.0%
4/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Blood and lymphatic system disorders
Anemia (Post Op)
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Infections and infestations
Appendicitis
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis-Left
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Cardiac disorders
Atrial Fibrillation
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Nervous system disorders
Bell's Palsy
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Bilateral Groin Hematomas
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Bilateral Hip Wounds
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Renal and urinary disorders
Bilateral Hydronephrosis
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Bilateral Inguinal Hematoma
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Bilateral Pleural Effusions
|
40.0%
2/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
40.0%
2/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Bilateral Subdural Hematoma
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
General disorders
Chest Pain
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Gastrointestinal disorders
Chronic Constipation
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Renal and urinary disorders
Chronic Renal Failure
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst Left Kidney
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
General disorders
Decubitus Ulcer
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Cardiac disorders
Demand Ischemia/Elevated Troponin
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Surgical and medical procedures
Dissection Of Left Axillary Artery
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Infections and infestations
Diverticulitis
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Deep vein thrombosis (DVT)
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
General disorders
Edema Posterior Paraspinal Musculature
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
General disorders
Edema-Lower Extremities
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Endoleak Stable Type 2
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Endoleak Type 2
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Endoleak Type 2 (Stable)
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
General disorders
Fever
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
40.0%
2/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Gastrointestinal disorders
Gallbladder Distention
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Gluteal Hematoma
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Gluteal Wound
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Ear and labyrinth disorders
Hearing Loss
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Hematoma Spinal Drain Site
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Hematoma X 2 Left Upper Arm
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Surgical and medical procedures
Hepatic Artery Extravasation Dissection
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
40.0%
2/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Blood and lymphatic system disorders
Hypervolemia
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Blood and lymphatic system disorders
Hyponatremia
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Cardiac disorders
Intermittent Atrial Fibrillation
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Psychiatric disorders
Intermittent Confusion
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Renal and urinary disorders
Intermittent Urinary Retention
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Intraoperative Blood Loss
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Cardiac disorders
Left Atrial Dilatation
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
General disorders
Left Axillary Fluid Collection
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Left Lobe Atelectasis
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
60.0%
3/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Cardiac disorders
Moderate-Severe Mid Right Coronary Artery Disease
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Nervous system disorders
Neurogenic Bladder
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Nervous system disorders
Neurogenic Bowel
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Nervous system disorders
Neurogenic Ileus
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Reproductive system and breast disorders
Penile Edema
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Reproductive system and breast disorders
Penile Ulcer
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Reproductive system and breast disorders
Penile/Scrotal Edema
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion Left
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Blood and lymphatic system disorders
Postoperative Anemia
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progression Of Metastatic Breast Cancer
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Pulmonary Hypertension
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Skin and subcutaneous tissue disorders
Rash-Lace Pattern-Feet
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Renal and urinary disorders
Renal Stone
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Insufficiency
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
General disorders
Right Heel Ulcer
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Right Heel Wound
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Injury, poisoning and procedural complications
Sacral Wound
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness Of Breath
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Bradycaria
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Psychiatric disorders
Situational Depression
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Small Splenic Infarct
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Vascular disorders
Splenic Infarct
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
80.0%
4/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
60.0%
3/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Metabolism and nutrition disorders
Toxic Metabolic Encephalopathy
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Renal and urinary disorders
Urinary Retention
|
20.0%
1/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
0.00%
0/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
80.0%
4/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
60.0%
3/5 • 5 years
Assessed via physical examination, blood samples, metabolic panel, and other tests at follow-up visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place