Thoracoabdominal Aortic Aneurysm
Conditions
Brief summary
Prospective, non-randomized, , multicenter study with two independent arms: * Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. * Up to 65 additional subjects may be implanted in Continued Access Phase under the Primary Study Arm only * Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non hypothesis-driven analysis. Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional subjects implanted in Continued Access (Primary Study arm)
Interventions
Endovascular Aortic Stent-Graft
Sponsors
W.L.Gore & Associates
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study contains two single arm substudies. A primary study arm and a secondary study arm.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following: * Fusiform aneurysm diameter ≥ 5 cm * Saccular aneurysm (no diameter requirement) * Rapid aneurysm growth (≥ 5 mm in one year) 2. Aortic aneurysm that involves the abdominal aorta, with: * Involvement of at least one visceral vessel and aneurysmal extension as far as 65 mm proximal to the celiac artery, and/or * No normal aorta between the upper extent of aneurysm and renal artery(s) 3. Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required) 4. Age ≥ 19 years at the time of informed consent signature 5. Male or infertile female 6. Patient assessment favors an endovascular approach when compared to open surgical repair, as deemed by the treating physician 7. Capable of complying with protocol requirements, including follow-up 8. An Informed Consent Form signed by Subject or legal representative 9. Sufficient distal landing zones in both iliac arteries, with at least one patent internal iliac artery and without planned placement of a branched iliac device, or planned coverage/occlusion/embolization of any patent internal iliac artery. 10. Appropriate aortic anatomy to receive the TAMBE Device defined as all of the following: * For the TAMBE aortic component, proximal aortic landing zone diameters between 22-34 mm * Proximal seal zone ≥ 20 mm in length * Aortic neck angle ≤ 60° * Distal landing zone (iliac arteries) 8-25 mm * Distal seal zone in iliac arteries of at least 10 mm in length * Renal artery landing zone diameters between 4-10 mm * Celiac and superior mesenteric artery landing zone diameters between 5-12 mm * ≥ 15 mm landing zone in each branch vessel * Landing zones in the proximal and distal aorta and all branch vessels cannot be aneurysmal, heavily calcified, or heavily thrombosed * Patent left subclavian artery Secondary Study Arm Only: 11. If aneurysm extends greater than 65 mm above celiac artery, proximal extension with a CTAG Device is required. The aortic landing zone diameter treatment range with the CTAG Device is 19.5-32 mm 12. The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left subclavian artery. 13. The most proximal aortic device seal zone will be within native aorta or a previously-deployed TAG or CTAG Device • Placement inside a Dacron graft or another device manufacturer's stent graft will not be supported
Exclusion criteria
The patient is / has: 1. Prior open, aortic surgery of the ascending aorta or aortic arch 2. Ruptured or leaking aortic aneurysm 3. Aneurysmal dilatation due to chronic aortic dissection 4. Infected aorta 5. Mycotic aneurysm 6. Life expectancy \<2 years 7. Myocardial infarction or stroke within 1 year of treatment (staged or index procedure) 8. Systemic infection which may increase risk of endovascular graft infection 9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome 10. Participation in an investigational drug study (within 30 days of last administration) or investigational medical device study (within 1 year of implant) from the time of study screening 11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment 12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access 13. A branch vessel(s) that is dissected or has significant calcification, tortuosity, thrombus formation that would interfere with device delivery or ability to exclude from blood flow 14. Known sensitivities or allergies to the device materials 15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 16. Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta 17. Renal Insufficiency (creatinine value \> 1.8 mg/dL, GFR \< 30, or patient undergoing dialysis) 18. Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to require surgical intervention within one year of study treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality | 12 Months | Composite Outcome of Lesions-Related Mortality and Clinically Significant Reinterventions through 12 Months for Pre-defined Reasons. |
| Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event | From start of Index Procedure to 59 Days Post Procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With Aneurysm-related Mortality | 30 days | — |
| Percent of Subjects With Stented Segment Aortic Rupture | 30 days | — |
| Percent of Subjects With Lesion Related Mortality | 30 days | — |
| Percent of Subjects With Permanent Paraplegia | 30 days | — |
| Percent of Subjects With Permanent Paraparesis | 30 days of index procedure | — |
| Percent of Subjects With New Onset Renal Failure Requiring Dialysis | 30 days | — |
| Percent of Subjects With Severe Bowel Ischemia | 30 days | — |
| Percent of Subjects With Disabling Stroke | 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) |
| Percent of Subjects With Access-Related Complications | 30 days of index procedure | — |
| Mean Procedural Blood Loss at Index Procedure | Index Procedure | — |
| Procedure Time | Index Procedure | — |
| Percent of Subjects With Type I Endoleak | 12 Months | Endoleak 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. |
| Percent of Subjects With Type II Endoleak | 12 Months | Endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch. |
| Percent of Subjects With Type III Endoleak | 12 Months | Type 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 |
| Percent of Subjects With Type IV Endoleak | 12 Months | Endoleak 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 |
| Percent of Subjects With Type IV Indeterminate Endoleak | 12 Months | Endoleak 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 |
| Percent of Subjects With Device Migration | 12 Months | Longitudinal 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 |
| Percent of Subject With Thoracoabdominal Aneurysm (TAAA) Enlargement | 12 Months | An 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 |
| Percent of Subjects With Severe Distal Thromboembolic Events | 12 Months | — |
| Percent of Subjects With Aortic Rupture | 12 Months | — |
| Percent of Subjects With Device or Procedure-related Laparotomy | 12 Months | — |
| Percent of Subjects With Conversion to Open Repair | 12 Months | — |
| Percent of Subjects With Aortoiliac Device Limb Occlusion | 12 Months | — |
| Percent of Subjects With Loss of Device Integrity | 12 Months | Defined 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 |
| Percent of Subjects With Reintervention | 12 Months | An additional unanticipated interventional or surgical procedure (including conversion to open surgery), related to the device (including withdrawal of the delivery system) or procedure. |
| Percent of Subjects With Primary Patency | 12 Months | Blood 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) |
| Percent of Subjects With Secondary Patency | 12 Months | Blood flow through the device regardless of reinterventions performed (with or without occlusion) and freedom from surgical bypass |
| Percent of Subjects With Acute Kidney Injury | 30 Days | \>50% decrease in eGFR within 30 day follow-up window of TAMBE Device treatment when compared to pre-treatment serum creatinine value. |
| Length of Hospital Stay | 12 months | — |
| Percent of Subjects With Renal Function Deterioration | 12 Months | A sustained \>25% decrease in eGFR over two consecutive study visits following TAMBE Device treatment when compared to pre-treatment serum creatinine value |
| Percent of Subjects With Extended Technical Clinical Success | 30 days | Patients 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. |
Countries
United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORMark Farber, MD
University of North Carolina
Participant flow
Pre-assignment details
Subjects went through Screening after Enrollment. Subjects available and eligible for Primary Arm were implanted.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | Primary Study Arm |
|---|---|
| Age, Continuous | 73.3 years STANDARD_DEVIATION 3.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 92 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 84 Participants |
| Region of Enrollment United Kingdom | 3 participants |
| Region of Enrollment United States | 99 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 6 / 102 |
| other Total, other adverse events | 92 / 102 |
| serious Total, serious adverse events | 52 / 102 |
Outcome results
Primary
Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality
Composite Outcome of Lesions-Related Mortality and Clinically Significant Reinterventions through 12 Months for Pre-defined Reasons.
Time frame: 12 Months
Population: Subjects not available for assessment at 12 months were excluded from the analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Study Arm | 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 |
| Primary Study Arm | Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality | Clinically Significant Reintervention Through 12 Months | 25 Participants |
| Primary Study Arm | Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality | Clinically-Indicated Condition | 6 Participants |
| Primary Study Arm | Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality | Untreated Device Seal Zone Endoleak | 0 Participants |
| Primary Study Arm | Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality | Target-Lesion Growth > 5mm | 5 Participants |
| Primary Study Arm | Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality | Rupture | 1 Participants |
| Primary Study Arm | Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality | Failure of Device Effectiveness (Compromise Device Seal Zone/Integrity2) | 7 Participants |
| Primary Study Arm | Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality | Patient Safety Events (Total Occlusion of Device component2) | 14 Participants |
| Primary Study Arm | Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality | Complicated Device System Prophylaxis (RI req Hospitalization2) | 4 Participants |
| Primary Study Arm | Percent of Subjects Free From Clinically Significant Reintervention / Lesion-Related Mortality | Lesion Related Mortality Through 12 Months | 0 Participants |
p-value: 0.701790% CI: [61.4, 78.7]Fisher Exact
Primary
Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event
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
Time frame: From start of Index Procedure to 59 Days Post Procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Study Arm | 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 |
| Primary Study Arm | 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 |
| Primary Study Arm | 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 |
| Primary Study Arm | 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 |
| Primary Study Arm | 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 |
| Primary Study Arm | Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event | Unplanned Placement of Non-TAMBE(During Index Procedure) | 19 Participants |
| Primary Study Arm | 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 |
| Primary Study Arm | Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event | Failure of Successful Withdrawal(During Index Procedure) | 0 Participants |
| Primary Study Arm | Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event | Procedural Safety Events (Index Procedure to 59 Days) | 8 Participants |
| Primary Study Arm | 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 |
| Primary Study Arm | Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event | Lesion Related Mortality(Index Procedure to 59 Days) | 0 Participants |
| Primary Study Arm | Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event | Permanent Paraplegia(Index Procedure to 59 Days) | 2 Participants |
| Primary Study Arm | Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event | Permanent Paraparesis(Index Procedure to 59 Days) | 3 Participants |
| Primary Study Arm | 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 |
| Primary Study Arm | Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event | Severe Bowel Ischemia(Index Procedure to 59 Days) | 0 Participants |
| Primary Study Arm | Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event | Disabling Stroke(Index Procedure to 59 Days) | 1 Participants |
p-value: 0.590890% CI: [69.6, 84.1]Fisher Exact
Secondary
Length of Hospital Stay
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Study Arm | Length of Hospital Stay | 4.9 days | Standard Deviation 3.45 |
Secondary
Mean Procedural Blood Loss at Index Procedure
Time frame: Index Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Study Arm | Mean Procedural Blood Loss at Index Procedure | 299.9 ml | Standard Deviation 295.5 |
Secondary
Percent of Subjects With Access-Related Complications
Time frame: 30 days of index procedure
Secondary
Percent of Subjects With Acute Kidney Injury
\>50% decrease in eGFR within 30 day follow-up window of TAMBE Device treatment when compared to pre-treatment serum creatinine value.
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Acute Kidney Injury | 4 Participants |
Secondary
Percent of Subjects With Aneurysm-related Mortality
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Aneurysm-related Mortality | 0 Participants |
Secondary
Percent of Subjects With Aortic Rupture
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Aortic Rupture | 1 Participants |
Secondary
Percent of Subjects With Aortoiliac Device Limb Occlusion
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Aortoiliac Device Limb Occlusion | 0 Participants |
Secondary
Percent of Subjects With Conversion to Open Repair
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Conversion to Open Repair | 0 Participants |
Secondary
Percent of Subjects With Device Migration
Longitudinal 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
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Device Migration | 0 Participants |
Secondary
Percent of Subjects With Device or Procedure-related Laparotomy
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Device or Procedure-related Laparotomy | 4 Participants |
Secondary
Percent of Subjects With Disabling Stroke
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)
Time frame: 120 days (30 Days for Initial Stroke, plus 90 Days for Followup MRS Score)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Disabling Stroke | 1 Participants |
Secondary
Percent of Subjects With Extended Technical Clinical Success
Patients 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.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Extended Technical Clinical Success | 0 Participants |
Secondary
Percent of Subjects With Lesion Related Mortality
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Lesion Related Mortality | 0 Participants |
Secondary
Percent of Subjects With Loss of Device Integrity
Defined 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
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Loss of Device Integrity | 14 Participants |
Secondary
Percent of Subjects With New Onset Renal Failure Requiring Dialysis
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With New Onset Renal Failure Requiring Dialysis | 2 Participants |
Secondary
Percent of Subjects With Permanent Paraparesis
Time frame: 30 days of index procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Permanent Paraparesis | 3 Participants |
Secondary
Percent of Subjects With Permanent Paraplegia
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Permanent Paraplegia | 2 Participants |
Secondary
Percent of Subjects With Primary Patency
Blood 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)
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Primary Patency | 61 Participants |
Secondary
Percent of Subjects With Reintervention
An additional unanticipated interventional or surgical procedure (including conversion to open surgery), related to the device (including withdrawal of the delivery system) or procedure.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Reintervention | 15 Participants |
Secondary
Percent of Subjects With Renal Function Deterioration
A sustained \>25% decrease in eGFR over two consecutive study visits following TAMBE Device treatment when compared to pre-treatment serum creatinine value
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Renal Function Deterioration | 14 Participants |
Secondary
Percent of Subjects With Secondary Patency
Blood flow through the device regardless of reinterventions performed (with or without occlusion) and freedom from surgical bypass
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Secondary Patency | 79 Participants |
Secondary
Percent of Subjects With Severe Bowel Ischemia
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Severe Bowel Ischemia | 0 Participants |
Secondary
Percent of Subjects With Severe Distal Thromboembolic Events
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Severe Distal Thromboembolic Events | 2 Participants |
Secondary
Percent of Subjects With Stented Segment Aortic Rupture
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Stented Segment Aortic Rupture | 1 Participants |
Secondary
Percent of Subjects With Type I Endoleak
Endoleak 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.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Type I Endoleak | 0 Participants |
Secondary
Percent of Subjects With Type II Endoleak
Endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch.
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Type II Endoleak | 64 Participants |
Secondary
Percent of Subjects With Type III Endoleak
Type 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
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Type III Endoleak | 0 Participants |
Secondary
Percent of Subjects With Type IV Endoleak
Endoleak 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
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Type IV Endoleak | 0 Participants |
Secondary
Percent of Subjects With Type IV Indeterminate Endoleak
Endoleak 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
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subjects With Type IV Indeterminate Endoleak | 14 Participants |
Secondary
Percent of Subject With Thoracoabdominal Aneurysm (TAAA) Enlargement
An 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
Time frame: 12 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Study Arm | Percent of Subject With Thoracoabdominal Aneurysm (TAAA) Enlargement | 5 Participants |
Secondary
Procedure Time
Time frame: Index Procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Primary Study Arm | Procedure Time | 315.3 minutes | Standard Deviation 103.3 |