Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Thoracoabdominal Aortic Aneurysm
• Intervention / Treatment: Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SEH 7EH
    • Guy's and St. Thomas' NHS Foundation Trust
  • London, United Kingdom, W2 1NY
    • St. Mary's Hospital, Imperial College Healthcare, NHS Trust
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90033
      • Keck Medical Center of USC
    • San Francisco, California, United States, 94118
      • Kaiser Permanente San Francisco Medical Center
    • Stanford, California, United States, 94305
      • Stanford University
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Health Research Institute - MedStar Washington Hospital
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida - Gainesville
    • Tampa, Florida, United States, 33606
      • University Of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46226
      • Indiana University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan - Cardiac Surgery
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Essentia Health
    • Minneapolis, Minnesota, United States, 55407
      • Division of Vascular Surgery - Minneapolis Heart Institute
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic - Rochester
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai West
    • New York, New York, United States, 10065
      • Weill Cornell Medical Center
    • Rochester, New York, United States, 14627
      • University of Rochester
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Sanger Heart & Vascular Institute
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPP Heart and Vascular Institute
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee -University Vascular Surgeons
  • Texas
    • Austin, Texas, United States, 78705
      • St. David's Healthcare
    • Dallas, Texas, United States, 75226
      • Baylor Heart & Vascular Hospital
    • Dallas, Texas, United States, 75352
      • University of Texas Southwestern
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center
    • Houston, Texas, United States, 77030
      • The Methodist Hospital - Houston
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Medical Group
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic Hospitals
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin - Madison
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Health Care, Metro Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Primary Study Arm; TAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)	Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis; Endovascular Aortic Stent-Graft; Other Names: TAMBE
Experimental: Secondary Study Arm; TAAA requiring TAMBE System and CTAG Device(s). Crawford Type I-III (n= 20 - 100)	Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis; Endovascular Aortic Stent-Graft; Other Names: TAMBE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Procedural Blood Loss at Index Procedure		Index Procedure
Procedure Time		Index Procedure
Length of Hospital Stay		12 months
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	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; No significant disability. Able to carry out all usual activities, despite some symptoms; Slight Disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; Moderate Disability. Requires some help, but able to walk unassisted; Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; Severe Disability. Requires constant nursing care and attention, bedridden, incontinent; 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)	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
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; 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.	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.; 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	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: 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	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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Mark Farber, MD, University of North Carolina

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Actual): January 4, 2023
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Aortic Aneurysm, Thoracoabdominal
• Other Study ID Numbers: AAA 17-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes