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Thoracoabdominal Aortic AneurysmTAMBENCT03728985

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

A study testing GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in people with Thoracoabdominal Aortic Aneurysm, run by W.L.Gore & Associates at 44 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Prospective, non-randomized, , multicenter study with two independent arms: Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Thoracoabdominal Aortic Aneurysm
What is being tested?
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
44 sitesin 2 countries
Study dates
17 Jun 2019to Jan 2030
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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
Show all 29Show fewer
  • No normal aorta between the upper extent of aneurysm and renal artery(s)
  • 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:
  • 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:
  • 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

Who cannot join

  • The patient is / has:
  • Prior open, aortic surgery of the ascending aorta or aortic arch
  • Ruptured or leaking aortic aneurysm
  • Aneurysmal dilatation due to chronic aortic dissection
  • Infected aorta
  • Mycotic aneurysm
Show all 19Show fewer
  • Life expectancy <2 years
  • Myocardial infarction or stroke within 1 year of treatment (staged or index procedure)
  • Systemic infection which may increase risk of endovascular graft infection
  • Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
  • 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
  • History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of treatment
  • Tortuous or stenotic iliac and / or femoral arteries and the inability to use a conduit for vascular access
  • 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
  • Known sensitivities or allergies to the device materials
  • Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
  • Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
  • Renal Insufficiency (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoing dialysis)
  • Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to require surgical intervention within one year of study treatment

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

United States42 sites

  • University of Michigan - Cardiac Surgery

    Ann Arbor, Michigan, 48109

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • St. David's Healthcare

    Austin, Texas, 78705

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Sanger Heart & Vascular Institute

    Charlotte, North Carolina, 28203

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Baylor Heart & Vascular Hospital

    Dallas, Texas, 75226

  • University of Texas Southwestern

    Dallas, Texas, 75352

  • Essentia Health

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • University of Florida - Gainesville

    Gainesville, Florida, 32610

  • Baylor College of Medicine

    Houston, Texas, 77030

  • The Methodist Hospital - Houston

    Houston, Texas, 77030

  • University of Texas Health Science Center

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46226

  • University of Tennessee -University Vascular Surgeons

    Knoxville, Tennessee, 37920

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Keck Medical Center of USC

    Los Angeles, California, 90033

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Wisconsin - Madison

    Madison, Wisconsin, 53792

  • Aurora Health Care, Metro Inc.

    Milwaukee, Wisconsin, 53215

  • Division of Vascular Surgery - Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Mount Sinai West

    New York, New York, 10019

  • Weill Cornell Medical Center

    New York, New York, 10065

  • Sentara Medical Group

    Norfolk, Virginia, 23507

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • UPP Heart and Vascular Institute

    Pittsburgh, Pennsylvania, 15213

  • Carilion Clinic Hospitals

    Roanoke, Virginia, 24014

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14627

  • Kaiser Permanente San Francisco Medical Center

    San Francisco, California, 94118

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • University of Washington

    Seattle, Washington, 98195

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University

    Stanford, California, 94305

  • University of South Florida

    Tampa, Florida, 33606

  • MedStar Health Research Institute - MedStar Washington Hospital

    Washington D.C., District of Columbia, 20010

Other trials in United States

United Kingdom2 sites

  • Guy's and St. Thomas' NHS Foundation Trust

    London, SEH 7EH

  • St. Mary's Hospital, Imperial College Healthcare, NHS Trust

    London, W2 1NY

Other trials in United Kingdom

About this study

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)

Being tested
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Medical subject headings
Aortic Aneurysm, Thoracoabdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GORE EXCLUDER Thoracoabdominal Branch EndoprosthesisDevice

    Also called TAMBE

    Endovascular Aortic Stent-Graft

Study groups in NCT03728985
Study groupRoleWhat they receive
Primary Study ArmActive comparatorTAAA requiring only TAMBE System. Crawford Type IV TAAA and Pararenal (n= 102)
Receives: Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Secondary Study ArmExperimentalTAAA requiring TAMBE System and CTAG Device(s). Crawford Type I-III (n= 20 - 100)
Receives: Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: From start of Index Procedure to 59 Days Post Procedure

  2. 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.

    Measured: 12 Months

Secondary outcomes (31)

  1. Percent of Subjects With Aneurysm-related Mortality

    Measured: 30 days

  2. Percent of Subjects With Stented Segment Aortic Rupture

    Measured: 30 days

  3. Percent of Subjects With Lesion Related Mortality

    Measured: 30 days

  4. Percent of Subjects With Permanent Paraplegia

    Measured: 30 days

  5. Percent of Subjects With Permanent Paraparesis

    Measured: 30 days of index procedure

  6. Percent of Subjects With New Onset Renal Failure Requiring Dialysis

    Measured: 30 days

  7. Percent of Subjects With Severe Bowel Ischemia

    Measured: 30 days

  8. 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)

    Measured: 120 days (30 Days for Initial Stroke, plus 90 Days for Followup MRS Score)

  9. Percent of Subjects With Access-Related Complications

    Measured: 30 days of index procedure

  10. Mean Procedural Blood Loss at Index Procedure

    Measured: Index Procedure

  11. Procedure Time

    Measured: Index Procedure

  12. Length of Hospital Stay

    Measured: 12 months

  13. 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.

    Measured: 30 days

  14. 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.

    Measured: 12 Months

  15. Percent of Subjects With Type II Endoleak

    Endoleak arising from a patent branch vessel perfusing the aneurysm, e.g., lumbar or inferior mesenteric branch.

    Measured: 12 Months

  16. 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

    Measured: 12 Months

  17. 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

    Measured: 12 Months

  18. 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

    Measured: 12 Months

  19. 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

    Measured: 12 Months

  20. 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

    Measured: 12 Months

  21. Percent of Subjects With Severe Distal Thromboembolic Events

    Measured: 12 Months

  22. Percent of Subjects With Aortic Rupture

    Measured: 12 Months

  23. Percent of Subjects With Device or Procedure-related Laparotomy

    Measured: 12 Months

  24. Percent of Subjects With Conversion to Open Repair

    Measured: 12 Months

  25. Percent of Subjects With Aortoiliac Device Limb Occlusion

    Measured: 12 Months

  26. 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

    Measured: 12 Months

  27. 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.

    Measured: 12 Months

  28. 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)

    Measured: 12 Months

  29. Percent of Subjects With Secondary Patency

    Blood flow through the device regardless of reinterventions performed (with or without occlusion) and freedom from surgical bypass

    Measured: 12 Months

  30. 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.

    Measured: 30 Days

  31. 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

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study start17 Jun 2019
  3. Primary completion4 Jan 2023
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This study contains two single arm substudies. A primary study arm and a secondary study arm.
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03728985
Sponsor's protocol ID
AAA 17-01
Acronym
TAMBE
Status last verified
Aug 2026
First submitted
28 Sep 2018
Last updated
2 Sep 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No
Expanded access
Available

Publications

  • 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.

    PubMed 40480617

  • 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.

    PubMed 38904579

Questions about this trial

What is this clinical trial studying?

A study testing GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis in people with Thoracoabdominal Aortic Aneurysm, run by W.L.Gore & Associates at 44 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent of Subjects With Uncomplicated Technical Success and Freedom From Procedural Safety Composite Event (time frame: From start of Index Procedure to 59 Days Post Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03728985, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

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