Trial Outcomes & Findings for CTAG Dissection/Trauma Post Marketing Surveillance Japan (NCT NCT05414318)
NCT ID: NCT05414318
Last Updated: 2024-10-03
Results Overview
Number of subjects who achieved the primary entry tear exclusion
Recruitment status
COMPLETED
Target enrollment
55 participants
Primary outcome timeframe
At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)
Results posted on
2024-10-03
Participant Flow
Participant milestones
| Measure |
Dissection
Acute complicated Stanford type B dissection: Patients are enrolled and surveyed if the device is used in patients with complicated acute Stanford Type B aortic dissection at sites that contracted for this survey
|
Trauma
Traumatic thoracic aortic injury: Patients are enrolled and surveyed if the device is used in patients with Traumatic thoracic aortic injury at sites that contracted for this survey
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
12
|
|
Overall Study
COMPLETED
|
21
|
5
|
|
Overall Study
NOT COMPLETED
|
22
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing Data for Some Participants
Baseline characteristics by cohort
| Measure |
Dissection
n=43 Participants
Acute complicated Stanford type B dissection
|
Trauma
n=12 Participants
Traumatic thoracic aortic injury
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=38 Participants • Missing Data for Some Participants
|
58.5 years
n=12 Participants • Missing Data for Some Participants
|
65 years
n=50 Participants • Missing Data for Some Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=43 Participants
|
2 Participants
n=12 Participants
|
12 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=43 Participants
|
10 Participants
n=12 Participants
|
43 Participants
n=55 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Japan
|
43 participants
n=43 Participants
|
12 participants
n=12 Participants
|
55 participants
n=55 Participants
|
|
Height
|
165 cm
n=38 Participants • Missing Data for Some Participants
|
166.5 cm
n=10 Participants • Missing Data for Some Participants
|
165 cm
n=48 Participants • Missing Data for Some Participants
|
|
Weight
|
63.9 kg
n=41 Participants • Missing Data for Some Participants
|
67.3 kg
n=12 Participants • Missing Data for Some Participants
|
66.0 kg
n=53 Participants • Missing Data for Some Participants
|
|
American Society of Anesthesiologists (ASA) Classification
ASA 1
|
13 Participants
n=43 Participants
|
3 Participants
n=12 Participants
|
16 Participants
n=55 Participants
|
|
American Society of Anesthesiologists (ASA) Classification
ASA II
|
10 Participants
n=43 Participants
|
0 Participants
n=12 Participants
|
10 Participants
n=55 Participants
|
|
American Society of Anesthesiologists (ASA) Classification
ASA III
|
11 Participants
n=43 Participants
|
5 Participants
n=12 Participants
|
16 Participants
n=55 Participants
|
|
American Society of Anesthesiologists (ASA) Classification
ASA IV
|
9 Participants
n=43 Participants
|
4 Participants
n=12 Participants
|
13 Participants
n=55 Participants
|
|
American Society of Anesthesiologists (ASA) Classification
ASA V
|
0 Participants
n=43 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=55 Participants
|
|
Pulmonary Disease
|
4 Participants
n=43 Participants
|
0 Participants
n=12 Participants
|
4 Participants
n=55 Participants
|
|
Renal Disease
|
2 Participants
n=43 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=55 Participants
|
|
Cerebrovascular Disease
|
6 Participants
n=43 Participants
|
0 Participants
n=12 Participants
|
6 Participants
n=55 Participants
|
|
Hypertension
|
29 Participants
n=43 Participants
|
2 Participants
n=12 Participants
|
31 Participants
n=55 Participants
|
|
Diabetes Mellitus
|
5 Participants
n=43 Participants
|
1 Participants
n=12 Participants
|
6 Participants
n=55 Participants
|
|
Prior Descending Thoracic Aorta Repair
|
0 Participants
n=43 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=55 Participants
|
|
At Risk for Graft Infection
|
0 Participants
n=43 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=55 Participants
|
|
Persistent Refractory Shock
|
3 Participants
n=43 Participants
|
2 Participants
n=12 Participants
|
5 Participants
n=55 Participants
|
|
Bowel Necrosis
|
1 Participants
n=43 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=55 Participants
|
|
Degenerative Connective Tissue Disease
|
1 Participants
n=43 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=55 Participants
|
PRIMARY outcome
Timeframe: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)Population: Patients with acute complicated Stanford type B dissection with evaluable result. (Not a protocol-defined endpoint for trauma arm and therefore not evaluated)
Number of subjects who achieved the primary entry tear exclusion
Outcome measures
| Measure |
Dissection
n=38 Participants
Acute complicated Stanford type B dissection
|
Trauma
Traumatic thoracic aortic injury
|
|---|---|---|
|
Primary Entry Tear Exclusion
1 Month
|
21 Participants
|
—
|
|
Primary Entry Tear Exclusion
6 Months
|
26 Participants
|
—
|
|
Primary Entry Tear Exclusion
12 Months
|
27 Participants
|
—
|
|
Primary Entry Tear Exclusion
24 Months
|
22 Participants
|
—
|
|
Primary Entry Tear Exclusion
36 Months
|
19 Participants
|
—
|
|
Primary Entry Tear Exclusion
48 Months
|
17 Participants
|
—
|
|
Primary Entry Tear Exclusion
60 Months
|
20 Participants
|
—
|
PRIMARY outcome
Timeframe: Procedure through 5 years (Day 0-2006)Population: Subjects with acute complicated Stanford type B dissection. (Not a protocol-defined endpoint for trauma arm and therefore not evaluated)
Number of subjects with Aortic Rupture
Outcome measures
| Measure |
Dissection
n=43 Participants
Acute complicated Stanford type B dissection
|
Trauma
Traumatic thoracic aortic injury
|
|---|---|---|
|
Aortic Rupture
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Procedure through 5 years (Day 0-2006)Number of subjects with major device-related adverse events
Outcome measures
| Measure |
Dissection
n=43 Participants
Acute complicated Stanford type B dissection
|
Trauma
n=12 Participants
Traumatic thoracic aortic injury
|
|---|---|---|
|
Major Device-related Adverse Events
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Post-procedure through 5 years (Day 1-2006)Incidence rate of secondary intervention treatment
Outcome measures
| Measure |
Dissection
n=42 Participants
Acute complicated Stanford type B dissection
|
Trauma
n=12 Participants
Traumatic thoracic aortic injury
|
|---|---|---|
|
Secondary Intervention Treatment
|
5 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)Population: Patients with acute complicated Stanford type B dissection with evaluable result. (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm)
Change in minimum true lumen diameter adjacent to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Outcome measures
| Measure |
Dissection
n=38 Participants
Acute complicated Stanford type B dissection
|
Trauma
Traumatic thoracic aortic injury
|
|---|---|---|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
1 Month · No Change
|
6 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
1 Month · Increase
|
18 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
24 Months · Decrease
|
0 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
24 Months · No Change
|
6 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
24 Months · Increase
|
23 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
36 Months · Decrease
|
0 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
36 Months · No Change
|
4 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
36 Months · Increase
|
18 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
48 Months · Decrease
|
0 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
48 Months · No Change
|
3 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
1 Month · Decrease
|
1 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
6 Months · Decrease
|
1 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
6 Months · No Change
|
3 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
6 Months · Increase
|
26 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
12 Months · Decrease
|
0 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
12 Months · No Change
|
7 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
12 Months · Increase
|
24 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
48 Months · Increase
|
16 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
60 Months · Decrease
|
0 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
60 Months · No Change
|
3 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Adjacent to Treated Segment
60 Months · Increase
|
18 Participants
|
—
|
PRIMARY outcome
Timeframe: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)Population: Patients with acute complicated Stanford type B dissection with evaluable result (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm)
Change in minimum true lumen diameter distal to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Outcome measures
| Measure |
Dissection
n=37 Participants
Acute complicated Stanford type B dissection
|
Trauma
Traumatic thoracic aortic injury
|
|---|---|---|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
12 Months · No Change
|
10 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
12 Months · Increase
|
16 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
24 Months · Decrease
|
0 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
1 Month · Decrease
|
0 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
1 Month · No Change
|
13 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
1 Month · Increase
|
11 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
6 Months · Decrease
|
1 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
6 Months · No Change
|
11 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
6 Months · Increase
|
14 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
12 Months · Decrease
|
0 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
24 Months · No Change
|
7 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
24 Months · Increase
|
19 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
36 Months · Decrease
|
0 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
36 Months · No Change
|
5 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
36 Months · Increase
|
15 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
48 Months · Decrease
|
0 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
48 Months · No Change
|
6 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
48 Months · Increase
|
12 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
60 Months · Decrease
|
0 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
60 Months · No Change
|
7 Participants
|
—
|
|
Change in Minimum True Lumen Diameter Distal to Treated Segment
60 Months · Increase
|
13 Participants
|
—
|
PRIMARY outcome
Timeframe: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)Population: Patients with acute complicated Stanford type B dissection with evaluable result (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm)
Change in maximum false lumen diameter adjacent to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Outcome measures
| Measure |
Dissection
n=38 Participants
Acute complicated Stanford type B dissection
|
Trauma
Traumatic thoracic aortic injury
|
|---|---|---|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
24 Months · Decrease
|
21 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
24 Months · No Change
|
2 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
24 Months · Increase
|
2 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
36 Months · Decrease
|
17 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
36 Months · No Change
|
2 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
48 Months · Decrease
|
15 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
48 Months · No Change
|
2 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
48 Months · Increase
|
1 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
1 Month · Decrease
|
18 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
1 Month · No Change
|
5 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
1 Month · Increase
|
1 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
6 Months · Decrease
|
23 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
6 Months · No Change
|
4 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
6 Months · Increase
|
0 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
12 Months · Decrease
|
24 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
12 Months · No Change
|
4 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
12 Months · Increase
|
1 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
36 Months · Increase
|
1 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
60 Months · Decrease
|
18 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
60 Months · No Change
|
0 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Adjacent to Treated Segment
60 Months · Increase
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: At each follow-up visit through 5 years: 1 Month (15-59 days), 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)Population: Patients with acute complicated Stanford type B dissection with evaluable result (Outcome not applicable for trauma arm - see Outcome Measure #9 for change in maximum lesion diameter for the trauma arm)
Change in maximum false lumen diameter distal to treated segment at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Outcome measures
| Measure |
Dissection
n=37 Participants
Acute complicated Stanford type B dissection
|
Trauma
Traumatic thoracic aortic injury
|
|---|---|---|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
1 Month · Increase
|
0 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
6 Months · Decrease
|
19 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
6 Months · No Change
|
5 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
1 Month · Decrease
|
14 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
1 Month · No Change
|
10 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
6 Months · Increase
|
1 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
12 Months · Decrease
|
20 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
12 Months · No Change
|
4 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
12 Months · Increase
|
2 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
24 Months · Decrease
|
15 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
24 Months · No Change
|
6 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
24 Months · Increase
|
2 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
36 Months · Decrease
|
12 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
36 Months · No Change
|
3 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
36 Months · Increase
|
4 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
48 Months · Decrease
|
14 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
48 Months · No Change
|
1 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
48 Months · Increase
|
2 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
60 Months · Decrease
|
15 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
60 Months · No Change
|
3 Participants
|
—
|
|
Change in Maximum False Lumen Diameter Distal to Treated Segment
60 Months · Increase
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: At each follow-up visit from 6 months through 5 years: 6 Months (60-242 days), 12 Months (243-546 days), 24 Months (547-911 days), 36 Months (912-1275 days), 48 Months (1276-1640 days), 60 Months (1641-2006 days)Population: Subjects with Traumatic thoracic aortic injury. (Outcome not applicable for dissection arm - see Outcome Measures #5-8 for change in true/false lumen diameter for the dissection arm)
Change in maximum lesion diameter at each follow-up visit: Decrease (\>=5mm) vs No change vs Increase (\>=5mm)
Outcome measures
| Measure |
Dissection
n=3 Participants
Acute complicated Stanford type B dissection
|
Trauma
Traumatic thoracic aortic injury
|
|---|---|---|
|
Change in Maximum Lesion Diameter
6 Months · Decrease
|
1 Participants
|
—
|
|
Change in Maximum Lesion Diameter
6 Months · No Change
|
2 Participants
|
—
|
|
Change in Maximum Lesion Diameter
6 Months · Increase
|
0 Participants
|
—
|
|
Change in Maximum Lesion Diameter
12 Months · Decrease
|
1 Participants
|
—
|
|
Change in Maximum Lesion Diameter
12 Months · No Change
|
2 Participants
|
—
|
|
Change in Maximum Lesion Diameter
12 Months · Increase
|
0 Participants
|
—
|
|
Change in Maximum Lesion Diameter
24 Months · Decrease
|
1 Participants
|
—
|
|
Change in Maximum Lesion Diameter
24 Months · No Change
|
2 Participants
|
—
|
|
Change in Maximum Lesion Diameter
24 Months · Increase
|
0 Participants
|
—
|
|
Change in Maximum Lesion Diameter
36 Months · Decrease
|
1 Participants
|
—
|
|
Change in Maximum Lesion Diameter
36 Months · No Change
|
0 Participants
|
—
|
|
Change in Maximum Lesion Diameter
36 Months · Increase
|
0 Participants
|
—
|
|
Change in Maximum Lesion Diameter
48 Months · Decrease
|
1 Participants
|
—
|
|
Change in Maximum Lesion Diameter
48 Months · No Change
|
1 Participants
|
—
|
|
Change in Maximum Lesion Diameter
48 Months · Increase
|
0 Participants
|
—
|
|
Change in Maximum Lesion Diameter
60 Months · Decrease
|
1 Participants
|
—
|
|
Change in Maximum Lesion Diameter
60 Months · No Change
|
0 Participants
|
—
|
|
Change in Maximum Lesion Diameter
60 Months · Increase
|
0 Participants
|
—
|
Adverse Events
Dissection
Serious events: 17 serious events
Other events: 0 other events
Deaths: 10 deaths
Trauma
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Dissection
n=43 participants at risk
Acute complicated Stanford type B dissection
|
Trauma
n=12 participants at risk
Traumatic thoracic aortic injury
|
|---|---|---|
|
Vascular disorders
Aortic Rupture
|
4.7%
2/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Vascular disorders
New Aortic Dissection
|
4.7%
2/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Vascular disorders
False Lumen Enlargement (>=5mm)
|
2.3%
1/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Respiratory, thoracic and mediastinal disorders
Atelactasis/Pneumonia
|
2.3%
1/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
2.3%
1/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Cardiac disorders
Congestive Heart Failure
|
7.0%
3/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Gastrointestinal disorders
Bowel Ischemia
|
7.0%
3/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Gastrointestinal disorders
Other Bowel Complication
|
2.3%
1/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Vascular disorders
Other Vascular Complication
|
2.3%
1/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Nervous system disorders
Paraplegia/Paraparesis
|
2.3%
1/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Infections and infestations
Prosthesis Infection
|
4.7%
2/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Infections and infestations
Other Infection
|
2.3%
1/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
General disorders
Other Complications (not device complication)
|
7.0%
3/43 • 5 years (Post-operative day 0-2006)
|
8.3%
1/12 • 5 years (Post-operative day 0-2006)
|
|
Vascular disorders
Endoleak Type Ia
|
2.3%
1/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Vascular disorders
Endoleak Type III
|
2.3%
1/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
|
Vascular disorders
Endoleak, Other
|
2.3%
1/43 • 5 years (Post-operative day 0-2006)
|
0.00%
0/12 • 5 years (Post-operative day 0-2006)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI is required to obtain written permission from the Sponsor prior to publishing trial results.
- Publication restrictions are in place
Restriction type: OTHER