Trial Outcomes & Findings for Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms (NCT NCT03728985)
NCT ID: NCT03728985
Last Updated: 2025-10-24
Results Overview
Percent of Subjects with Device Technical Success Composite Event and freedom from Procedural Safety Composite Event. Device Technical Success Composite Events during Index Procedure: Successful Access and Delivery Successful and Accurate Deployment Successful Withdrawal Procedural Safety during 30 days of Index Procedure: Stented Segment Aortic Rupture Lesion-Related Mortality Permanent Paraplegia Permanent Paraparesis New Onset Renal Failure Requiring Dialysis Severe Bowel Ischemia Disabling Stroke
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
102 participants
Primary outcome timeframe
From start of Index Procedure to 59 Days Post Procedure
Results posted on
2025-10-24
Participant Flow
Subjects went through Screening after Enrollment. Subjects available and eligible for Primary Arm were implanted.
Participant milestones
| Measure |
Primary Study Arm
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
Primary Endpoint Determined
|
102
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ethnicity only collected for subjects in the US
Baseline characteristics by cohort
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Age, Continuous
|
73.3 years
STANDARD_DEVIATION 3.39 • n=102 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=102 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants • Ethnicity only collected for subjects in the US
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
92 Participants
n=99 Participants • Ethnicity only collected for subjects in the US
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants • Ethnicity only collected for subjects in the US
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants • Subject Race is only collected for the subjects in the US
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants • Subject Race is only collected for the subjects in the US
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants • Subject Race is only collected for the subjects in the US
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants • Subject Race is only collected for the subjects in the US
|
|
Race (NIH/OMB)
White
|
84 Participants
n=99 Participants • Subject Race is only collected for the subjects in the US
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • Subject Race is only collected for the subjects in the US
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants • Subject Race is only collected for the subjects in the US
|
|
Region of Enrollment
United States
|
99 participants
n=102 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=102 Participants
|
PRIMARY outcome
Timeframe: From start of Index Procedure to 59 Days Post ProcedurePercent of Subjects with Device Technical Success Composite Event and freedom from Procedural Safety Composite Event. Device Technical Success Composite Events during Index Procedure: Successful Access and Delivery Successful and Accurate Deployment Successful Withdrawal Procedural Safety during 30 days of Index Procedure: Stented Segment Aortic Rupture Lesion-Related Mortality Permanent Paraplegia Permanent Paraparesis New Onset Renal Failure Requiring Dialysis Severe Bowel Ischemia Disabling Stroke
Outcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Subjects with Device Tech Success and Freedom from Procedural Safety Event (Index Proc to 59 Days)
|
79 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Failure of Device Uncomplicated Technical Success (During Index Procedure)
|
19 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Failure of Successful Access and Delivery(During Index Procedure)
|
0 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Failure of Successful and Accurate Deployment(During Index Procedure)
|
19 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Deployment/Kink/Twist/Obst/planned location(During Index Procedure)
|
1 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Unplanned Placement of Non-TAMBE(During Index Procedure)
|
19 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Use of Non-TAMBE to correct Iatrogenic(During Index Procedure)
|
4 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Failure of Successful Withdrawal(During Index Procedure)
|
0 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Procedural Safety Events (Index Procedure to 59 Days)
|
8 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Stented Segment Aortic Rupture (Index Procedure to 59 Days)
|
1 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Lesion Related Mortality(Index Procedure to 59 Days)
|
0 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Permanent Paraplegia(Index Procedure to 59 Days)
|
2 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Permanent Paraparesis(Index Procedure to 59 Days)
|
3 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
New Onset Renal Failure Requiring Dialysis(Index Procedure to 59 Days)
|
2 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Severe Bowel Ischemia(Index Procedure to 59 Days)
|
0 Participants
|
|
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
Disabling Stroke(Index Procedure to 59 Days)
|
1 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Subjects not available for assessment at 12 months were excluded from the analysis
Composite Outcome of Lesions-Related Mortality and Clinically Significant Reinterventions through 12 Months for Pre-defined Reasons.
Outcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Complicated Device System Prophylaxis (RI req Hospitalization2)
|
4 Participants
|
|
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Freedom from Clinically Sig. Reintervention and Lesion Related Mortality Through 12 Months
|
60 Participants
|
|
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Clinically Significant Reintervention Through 12 Months
|
25 Participants
|
|
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Clinically-Indicated Condition
|
6 Participants
|
|
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Untreated Device Seal Zone Endoleak
|
0 Participants
|
|
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Target-Lesion Growth > 5mm
|
5 Participants
|
|
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Rupture
|
1 Participants
|
|
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Failure of Device Effectiveness (Compromise Device Seal Zone/Integrity2)
|
7 Participants
|
|
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Patient Safety Events (Total Occlusion of Device component2)
|
14 Participants
|
|
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Lesion Related Mortality Through 12 Months
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Aneurysm-related Mortality
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Stented Segment Aortic Rupture
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Lesion Related Mortality
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Permanent Paraplegia
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 days of index procedureOutcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Permanent Paraparesis
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With New Onset Renal Failure Requiring Dialysis
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Severe Bowel Ischemia
|
0 Participants
|
SECONDARY outcome
Timeframe: 120 days (30 Days for Initial Stroke, plus 90 Days for Followup MRS Score)Stroke will be assessed using the Modified Rankin Scale. Stroke identified as having occurred within 30 days of the index endovascular procedure, combined with mRS ≥2 with an increase from baseline of at least one grade at 90 days. Modified Rankin Scale: 0 - No Symptoms 1. No significant disability. Able to carry out all usual activities, despite some symptoms 2. Slight Disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. Moderate Disability. Requires some help, but able to walk unassisted 4. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. Severe Disability. Requires constant nursing care and attention, bedridden, incontinent 6. Dead Higher Values are worse. A total score will not be computed, but a change from baseline will be calculated as (90 Day Post-Stroke MRS Score - Baseline MRS Score)
Outcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Disabling Stroke
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days of index procedureOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Index ProcedureOutcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Mean Procedural Blood Loss at Index Procedure
|
299.9 ml
Standard Deviation 295.5
|
SECONDARY outcome
Timeframe: Index ProcedureOutcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Procedure Time
|
315.3 minutes
Standard Deviation 103.3
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Primary Study Arm
n=102 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Length of Hospital Stay
|
4.9 days
Standard Deviation 3.45
|
SECONDARY outcome
Timeframe: 30 daysPatients who present within the 30-Day follow-up with no Type I or Type III endoleak, as evaluated by CTA, and free from device-related intervention.
Outcome measures
| Measure |
Primary Study Arm
n=93 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Extended Technical Clinical Success
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsEndoleak arising from the proximal or distal sealing zone of a device perfusing the aneurysm * Type IA: Inadequate seal at the proximal end of the device placed in the aorta * Type IB: Inadequate seal at the distal end of the device placed in iliac vessel * Type IC: Inadequate seal at the distal end of a device placed inside branch vessel Reported as ratio with the number of subjects with Type I Endoleak as numerator, number of subjects with an evaluable result as denominator. Ratios of Type IA, IB, and IC will also be reported.
Outcome measures
| Measure |
Primary Study Arm
n=81 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Type I Endoleak
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsEndoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch.
Outcome measures
| Measure |
Primary Study Arm
n=91 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Type II Endoleak
|
64 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsType III Endoleak through 12 months - Endoleak arising from the component junction(s) of the prosthesis or due to damage to the graft material perfusing the aneurysm. * Type III General: A Type III endoleak whose source cannot be differentiated between an intercomponent junction or graft tear * Type IIIA: Modular disconnection or apposition failure * Type IIIB: Graft tear
Outcome measures
| Measure |
Primary Study Arm
n=81 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Type III Endoleak
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsEndoleak of whole blood through the graft fabric perfusing the aneurysm Reported as a ratio. Numerator: Number of Subjects with Type IV Endoleak. Denominator: Number of Subjects with an Evaluable Result
Outcome measures
| Measure |
Primary Study Arm
n=81 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Type IV Endoleak
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsEndoleak perfusing the aneurysm without a definitive source Reported as a ratio. Numerator: Number of Subjects with Type IV Endoleak. Denominator: Number of Subjects with an Evaluable Result
Outcome measures
| Measure |
Primary Study Arm
n=84 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Type IV Indeterminate Endoleak
|
14 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsLongitudinal movement of all or part of the device for a distance ≥10 mm, as confirmed by CT scan, relative to anatomical landmarks and device positioning at the first post-operative CT scan
Outcome measures
| Measure |
Primary Study Arm
n=87 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Device Migration
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsAn increase in the maximum aneurysm diameter of 5 mm or more relative to the first post-operative CT scan within the 30 day follow-up window
Outcome measures
| Measure |
Primary Study Arm
n=93 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subject With Thoracoabdominal Aneurysm (TAAA) Enlargement
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Primary Study Arm
n=95 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Severe Distal Thromboembolic Events
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Primary Study Arm
n=94 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Aortic Rupture
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Primary Study Arm
n=95 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Device or Procedure-related Laparotomy
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Primary Study Arm
n=94 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Conversion to Open Repair
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsOutcome measures
| Measure |
Primary Study Arm
n=93 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Aortoiliac Device Limb Occlusion
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsDefined as any of the following: * Wire fracture identified in the sealing row stents of either the aortic, branch or iliac components * Transient (compression) or permanent stent-graft collapse (invagination) following complete device deployment, resulting in an overall reduction in the aortic, branch or iliac vessel luminal diameter
Outcome measures
| Measure |
Primary Study Arm
n=86 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Loss of Device Integrity
|
14 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsAn additional unanticipated interventional or surgical procedure (including conversion to open surgery), related to the device (including withdrawal of the delivery system) or procedure.
Outcome measures
| Measure |
Primary Study Arm
n=94 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Reintervention
|
15 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsBlood flow without occlusion maintained through the device after implant without an intervention. Assisted Primary Patency through 12 Months- Blood flow maintained through the device after implant regardless of re-interventions performed (without occlusion)
Outcome measures
| Measure |
Primary Study Arm
n=84 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Primary Patency
|
61 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsBlood flow through the device regardless of reinterventions performed (with or without occlusion) and freedom from surgical bypass
Outcome measures
| Measure |
Primary Study Arm
n=89 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Secondary Patency
|
79 Participants
|
SECONDARY outcome
Timeframe: 30 Days\>50% decrease in eGFR within 30 day follow-up window of TAMBE Device treatment when compared to pre-treatment serum creatinine value.
Outcome measures
| Measure |
Primary Study Arm
n=91 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Acute Kidney Injury
|
4 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsA sustained \>25% decrease in eGFR over two consecutive study visits following TAMBE Device treatment when compared to pre-treatment serum creatinine value
Outcome measures
| Measure |
Primary Study Arm
n=74 Participants
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Percent of Subjects With Renal Function Deterioration
|
14 Participants
|
Adverse Events
Primary Study Arm
Serious events: 52 serious events
Other events: 92 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Primary Study Arm
n=102 participants at risk
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Blood and lymphatic system disorders
Chronic anemia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Blood and lymphatic system disorders
Symptomatic anemia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Acute decompensated heart failure
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Aortic valve insufficiency
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
3/102 • Number of events 3 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Atrial fibrillation with rapid ventricular response
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Chronic atrial fibrillation
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Chronic systolic heart failure
|
2.9%
3/102 • Number of events 3 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Congestive cardiac failure aggravated
|
2.9%
3/102 • Number of events 5 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Congestive heart failure
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Congestive heart failure with acute exacerbation
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Ischemic cardiomyopathy
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Myocardial infarction
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Non ST segment elevation myocardial infarction
|
3.9%
4/102 • Number of events 4 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Non-sustained ventricular tachycardia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Paroxysmal atrial fibrillation
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Systolic heart failure
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.98%
1/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Bowel adhesions
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Celiac artery stenosis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Dysphagia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Dysphagia aggravated
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.98%
1/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Hematochezia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Ileus
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Lower gastrointestinal bleeding
|
2.9%
3/102 • Number of events 3 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Mesenteric ischemia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Necrotizing pancreatitis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Pancreatitis due to gallstones
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Rectal bleeding
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Retroperitoneal hematoma
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Gastrointestinal disorders
Short-bowel syndrome
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Arterial stent occlusion
|
2.0%
2/102 • Number of events 3 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Bare metal stent stenosis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Calf swelling
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Endoleak
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Fever of unknown origin
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Non-cardiac chest pain
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Renal stent-graft thrombosis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Stent stenosis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Stent thrombosis
|
0.98%
1/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Stent-graft endoleak type IA
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Stent-graft endoleak type IC
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Stent-graft endoleak type II
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Unknown cause of death
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Vascular stent thrombosis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Weakness generalized
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Hepatobiliary disorders
Acute cholecystitis
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Hepatobiliary disorders
Bile duct stricture
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Hepatobiliary disorders
Liver cirrhosis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Immune system disorders
Anaphylaxis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
Aspiration pneumonia
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
COVID-19
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
COVID-19 respiratory infection
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
Cellulitis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
Community acquired pneumonia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
Diverticulitis
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
Hospital acquired pneumonia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
Peritonitis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
Pneumonia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
Prosthesis related infection
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
SARS-CoV-2 infection
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
Sepsis
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
Septic shock
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
3/102 • Number of events 3 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Injury, poisoning and procedural complications
Femoral vein injury
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Injury, poisoning and procedural complications
Gastrostomy tube site complication
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Injury, poisoning and procedural complications
Pseudoaneurysm
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Metabolism and nutrition disorders
Volume overload
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Musculoskeletal and connective tissue disorders
Lower extremities weakness of
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of prostate
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer of descending colon
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of breast ductal
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of pancreas
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Nervous system disorders
Alzheimer's disease
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Nervous system disorders
Brain lesion
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Nervous system disorders
Encephalopathy
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Nervous system disorders
Paraplegia
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Nervous system disorders
Spinal cord ischemia
|
3.9%
4/102 • Number of events 4 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Nervous system disorders
Subarachnoid hemorrhage
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Nervous system disorders
TIA
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Nervous system disorders
Transient ischemic attack
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Psychiatric disorders
Delirium
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
6/102 • Number of events 7 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
Acute renal failure
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
End stage renal disease
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
End stage renal failure
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
Hematuria
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
Kidney atrophy
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
Renal artery dissection
|
2.9%
3/102 • Number of events 3 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
Renal artery occlusion
|
2.0%
2/102 • Number of events 3 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
Renal artery stenosis
|
2.9%
3/102 • Number of events 3 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
Renal artery thrombosis
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
Renal infarction
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Acute hypoxic respiratory failure
|
2.9%
3/102 • Number of events 3 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Acute on chronic respiratory failure
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.9%
3/102 • Number of events 3 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonitis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Basilar atelectasis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease exacerbation
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxic respiratory failure
|
2.9%
3/102 • Number of events 3 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.98%
1/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.0%
2/102 • Number of events 2 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Unilateral pleural effusion
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Skin and subcutaneous tissue disorders
Surgical emphysema
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Vascular disorders
Aortic rupture
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Vascular disorders
Atheroembolism
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Vascular disorders
Hemorrhagic shock
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Vascular disorders
Hypertensive emergency
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Vascular disorders
Popliteal artery thrombosis
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Vascular disorders
Type A aortic dissection
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Vascular disorders
Type B aortic dissection
|
0.98%
1/102 • Number of events 1 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
Other adverse events
| Measure |
Primary Study Arm
n=102 participants at risk
TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
6/102 • Number of events 6 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
General disorders
Stent-graft endoleak type II
|
57.8%
59/102 • Number of events 65 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Infections and infestations
COVID-19
|
6.9%
7/102 • Number of events 7 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.8%
8/102 • Number of events 8 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.9%
7/102 • Number of events 7 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
5.9%
6/102 • Number of events 8 • 0-4 Years
All subjects have not completed the 4 year follow-up, therefore the number and percentage of AEs may be under estimation of 4 year event rates.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Investigator must wait until after the multi-center manuscript is published. Investigator will provide all Publications to allow the sponsor to review at least 60 days in advance of submission for publication or other public disclosure to suggest any modifications to protect proprietary information, and extend (as applicable) if filing a patent application.
- Publication restrictions are in place
Restriction type: OTHER