Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective, non-randomized, , multicenter study with two independent arms:
Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis.
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Study Arm | Active Comparator | TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102) |
|
| Secondary Study Arm | Experimental | TAAA requiring TAMBE System and CTAG Device(s). Crawford Type I-III (n= 20 - 100) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis | Device | Endovascular Aortic Stent-Graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From start of Index Procedure to 59 Days Post Procedure |
| 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. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Aortic aneurysm involving the visceral vessels requiring treatment defined as at least one of the following:
Aortic aneurysm that involves the abdominal aorta, with:
Adequate access for TAMBE Device components (femoral, axillary, and / or brachial arteries as required)
Age ≥ 19 years at the time of informed consent signature
Male or infertile female
Patient assessment favors an endovascular approach when compared to open surgical repair, as deemed by the treating physician
Capable of complying with protocol requirements, including follow-up
An Informed Consent Form signed by Subject or legal representative
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.
Appropriate aortic anatomy to receive the TAMBE Device defined as all of the following:
Secondary Study Arm Only:
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
The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left subclavian artery.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Farber, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40480617 | Derived | Farber MA, Han S, Makaroun MS, Matsumura JS, Mendes BC, Oderich GS, Sanchez LA, Suckow BD, Timaran CH. One-year outcomes from the pivotal trial of a four-branch off-the-shelf solution to treat pararenal and extent IV thoracoabdominal aortic aneurysms. J Vasc Surg. 2025 Sep;82(3):740-749.e2. doi: 10.1016/j.jvs.2025.05.016. Epub 2025 Jun 4. | |
| 38904579 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Subjects went through Screening after Enrollment. Subjects available and eligible for Primary Arm were implanted.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2023 |
Not provided
This study contains two single arm substudies. A primary study arm and a secondary study arm.
Not provided
Not provided
Not provided
Not provided
| 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 | 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
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) | 120 days (30 Days for Initial Stroke, plus 90 Days for Followup 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 |
| Length of Hospital Stay | 12 months |
| 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. | 30 days |
| Percent of Subjects With Type I Endoleak | Endoleak arising from the proximal or distal sealing zone of a device perfusing the aneurysm
| 12 Months |
| Percent of Subjects With Type II Endoleak | Endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch. | 12 Months |
| 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.
| 12 Months |
| 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 | 12 Months |
| 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 | 12 Months |
| 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 | 12 Months |
| 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 | 12 Months |
| 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 | Defined as any of the following:
| 12 Months |
| 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. | 12 Months |
| 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) | 12 Months |
| Percent of Subjects With Secondary Patency | Blood flow through the device regardless of reinterventions performed (with or without occlusion) and freedom from surgical bypass | 12 Months |
| 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. | 30 Days |
| 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 | 12 Months |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Keck Medical Center of USC | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Kaiser Permanente San Francisco Medical Center | San Francisco | California | 94118 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| MedStar Health Research Institute - MedStar Washington Hospital | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida - Gainesville | Gainesville | Florida | 32610 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Indiana University | Indianapolis | Indiana | 46226 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan - Cardiac Surgery | Ann Arbor | Michigan | 48109 | United States |
| Essentia Health | Duluth | Minnesota | 55805 | United States |
| Division of Vascular Surgery - Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Mount Sinai West | New York | New York | 10019 | United States |
| Weill Cornell Medical Center | New York | New York | 10065 | United States |
| University of Rochester | Rochester | New York | 14627 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Sanger Heart & Vascular Institute | Charlotte | North Carolina | 28203 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| UPP Heart and Vascular Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Tennessee -University Vascular Surgeons | Knoxville | Tennessee | 37920 | United States |
| St. David's Healthcare | Austin | Texas | 78705 | United States |
| Baylor Heart & Vascular Hospital | Dallas | Texas | 75226 | United States |
| University of Texas Southwestern | Dallas | Texas | 75352 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| The Methodist Hospital - Houston | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center | Houston | Texas | 77030 | United States |
| Sentara Medical Group | Norfolk | Virginia | 23507 | United States |
| Carilion Clinic Hospitals | Roanoke | Virginia | 24014 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| University of Wisconsin - Madison | Madison | Wisconsin | 53792 | United States |
| Aurora Health Care, Metro Inc. | Milwaukee | Wisconsin | 53215 | United States |
| Guy's and St. Thomas' NHS Foundation Trust | London | SEH 7EH | United Kingdom |
| St. Mary's Hospital, Imperial College Healthcare, NHS Trust | London | W2 1NY | United Kingdom |
| Farber MA, Matsumura JS, Han S, Makaroun MS, Suckow BD, Timaran CH, Mendes BC, Oderich GS. Early outcomes from the pivotal trial of a four-branch off-the shelf solution to treat complex abdominal and type IV thoracoabdominal aortic aneurysms. J Vasc Surg. 2024 Nov;80(5):1326-1335.e4. doi: 10.1016/j.jvs.2024.05.020. Epub 2024 Jun 20. |
| Primary Endpoint Determined |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Ethnicity only collected for subjects in the US | Count of Participants | Participants |
| |||||||||||||||||
| Race (NIH/OMB) | Subject Race is only collected for the subjects in the US | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | From start of Index Procedure to 59 Days Post Procedure |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Subjects not available for assessment at 12 months were excluded from the analysis | Posted | Count of Participants | Participants | 12 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Aneurysm-related Mortality | Posted | Count of Participants | Participants | 30 days |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Stented Segment Aortic Rupture | Posted | Count of Participants | Participants | 30 days |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Lesion Related Mortality | Posted | Count of Participants | Participants | 30 days |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Permanent Paraplegia | Posted | Count of Participants | Participants | 30 days |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Permanent Paraparesis | Posted | Count of Participants | Participants | 30 days of index procedure |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With New Onset Renal Failure Requiring Dialysis | Posted | Count of Participants | Participants | 30 days |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Severe Bowel Ischemia | Posted | Count of Participants | Participants | 30 days |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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
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) | Posted | Count of Participants | Participants | 120 days (30 Days for Initial Stroke, plus 90 Days for Followup MRS Score) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Access-Related Complications | Not Posted | 30 days of index procedure | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Procedural Blood Loss at Index Procedure | Posted | Mean | Standard Deviation | ml | Index Procedure |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Procedure Time | Posted | Mean | Standard Deviation | minutes | Index Procedure |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Length of Hospital Stay | Posted | Mean | Standard Deviation | days | 12 months |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Type I Endoleak | Endoleak arising from the proximal or distal sealing zone of a device perfusing the aneurysm
| Posted | Count of Participants | Participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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.
| Posted | Count of Participants | Participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Count of Participants | Participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Count of Participants | Participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Count of Participants | Participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Count of Participants | Participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Severe Distal Thromboembolic Events | Posted | Count of Participants | Participants | 12 Months |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Aortic Rupture | Posted | Count of Participants | Participants | 12 Months |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Device or Procedure-related Laparotomy | Posted | Count of Participants | Participants | 12 Months |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Conversion to Open Repair | Posted | Count of Participants | Participants | 12 Months |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Aortoiliac Device Limb Occlusion | Posted | Count of Participants | Participants | 12 Months |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percent of Subjects With Loss of Device Integrity | Defined as any of the following:
| Posted | Count of Participants | Participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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) | Posted | Count of Participants | Participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Count of Participants | Participants | 12 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Posted | Count of Participants | Participants | 30 Days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Posted | Count of Participants | Participants | 12 Months |
|
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 6 | 102 | 52 | 102 | 92 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Chronic anemia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Symptomatic anemia | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Acute decompensated heart failure | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Aortic valve insufficiency | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Atrial fibrillation with rapid ventricular response | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Chest pain - cardiac | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Chronic atrial fibrillation | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Chronic systolic heart failure | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Congestive cardiac failure aggravated | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Congestive heart failure with acute exacerbation | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Ischemic cardiomyopathy | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Non ST segment elevation myocardial infarction | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Non-sustained ventricular tachycardia | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Paroxysmal atrial fibrillation | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Systolic heart failure | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Bowel adhesions | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Celiac artery stenosis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Dysphagia aggravated | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Gastrointestinal bleed | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Gastrointestinal bleeding | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hematochezia | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Incarcerated inguinal hernia | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Jejunal perforation | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Lower gastrointestinal bleeding | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Mesenteric arterial occlusion | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Mesenteric artery stenosis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Mesenteric ischemia | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Necrotizing pancreatitis | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pancreatitis due to gallstones | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Rectal bleeding | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Retroperitoneal hematoma | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Short-bowel syndrome | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Arterial stent occlusion | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Bare metal stent stenosis | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Calf swelling | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Endoleak | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Fever of unknown origin | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Renal stent-graft thrombosis | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Stent stenosis | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Stent thrombosis | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Stent-graft endoleak type IA | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Stent-graft endoleak type IC | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Stent-graft endoleak type II | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Unknown cause of death | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Vascular stent thrombosis | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Weakness generalized | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Acute cholecystitis | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Bile duct stricture | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Liver cirrhosis | Hepatobiliary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Anaphylaxis | Immune system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Aspiration pneumonia | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| COVID-19 respiratory infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Community acquired pneumonia | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hospital acquired pneumonia | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Prosthesis related infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| SARS-CoV-2 infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Femoral vein injury | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
| |
| Gastrostomy tube site complication | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
| |
| Vascular injury | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA Version 26.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Volume overload | Metabolism and nutrition disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Lower extremities weakness of | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Adenocarcinoma of prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cancer of descending colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Systematic Assessment |
| |
| Carcinoma in situ of breast ductal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Systematic Assessment |
| |
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Systematic Assessment |
| |
| Malignant neoplasm of pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 26.0 | Systematic Assessment |
| |
| Alzheimer's disease | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Brain lesion | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Spinal cord ischemia | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Subarachnoid hemorrhage | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| TIA | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Transient ischemic attack | Nervous system disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| End stage renal failure | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Kidney atrophy | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Renal artery dissection | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Renal artery occlusion | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Renal artery stenosis | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Renal artery thrombosis | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Renal infarction | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Acute on chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Aspiration pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Basilar atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease exacerbation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Respiratory insufficiency | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Unilateral pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Surgical emphysema | Skin and subcutaneous tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Aortic rupture | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Atheroembolism | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hemorrhagic shock | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Popliteal artery thrombosis | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Type A aortic dissection | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Type B aortic dissection | Vascular disorders | MedDRA Version 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Stent-graft endoleak type II | General disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 26.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 26.0 | Systematic Assessment |
| |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA Version 26.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rizwan Afzal | W.L. Gore and Associates | 1-623-234-5408 | rafzal@wlgore.com |
| Feb 27, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Failure of Successful and Accurate Deployment(During Index Procedure) |
|
| Deployment/Kink/Twist/Obst/planned location(During Index Procedure) |
|
| Unplanned Placement of Non-TAMBE(During Index Procedure) |
|
| Use of Non-TAMBE to correct Iatrogenic(During Index Procedure) |
|
| Failure of Successful Withdrawal(During Index Procedure) |
|
| Procedural Safety Events (Index Procedure to 59 Days) |
|
| Stented Segment Aortic Rupture (Index Procedure to 59 Days) |
|
| Lesion Related Mortality(Index Procedure to 59 Days) |
|
| Permanent Paraplegia(Index Procedure to 59 Days) |
|
| Permanent Paraparesis(Index Procedure to 59 Days) |
|
| New Onset Renal Failure Requiring Dialysis(Index Procedure to 59 Days) |
|
| Severe Bowel Ischemia(Index Procedure to 59 Days) |
|
| Disabling Stroke(Index Procedure to 59 Days) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Title | Denominators | Categories |
|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|