New stent aims to fix dangerous aortic bulges without major surgery

NCT ID NCT03728985

Disease control Sponsor: W.L.Gore & Associates Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests a special stent device (GORE EXCLUDER) to treat thoracoabdominal and pararenal aortic aneurysms—bulges in the main artery that can rupture. About 102 people will receive the stent through a minimally invasive procedure. Researchers will check if the device is placed safely and if it prevents serious complications like rupture or paralysis within 30 days and beyond.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (a stent-graft device)
What this could lead to: If successful, this device could offer a less invasive way to repair complex aortic aneurysms, reducing the need for open surgery and lowering the risk of rupture.
What could go wrong: This is an early-stage study with only 102 participants, so results may not apply to everyone. The procedure carries risks like paralysis, kidney failure, or stroke.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

102 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic aneurysm Aortic Aneurysm, Thoracoabdominal thoracic aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thoracoabdominal aortic aneurysm

Contacts and locations

Locations

Aurora Health Care, Metro Inc.

Milwaukee, Wisconsin, 53215, United States
Baylor College of Medicine

Houston, Texas, 77030, United States
Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States
Carilion Clinic Hospitals

Roanoke, Virginia, 24014, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Cleveland Clinic

Cleveland, Ohio, 44195, United States
Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States
Division of Vascular Surgery - Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Emory University Hospital

Atlanta, Georgia, 30322, United States
Essentia Health

Duluth, Minnesota, 55805, United States
Guy's and St. Thomas' NHS Foundation Trust

London, SEH 7EH, United Kingdom
Indiana University

Indianapolis, Indiana, 46226, United States
Kaiser Permanente San Francisco Medical Center

San Francisco, California, 94118, United States
Keck Medical Center of USC

Los Angeles, California, 90033, United States
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States
Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States
MedStar Health Research Institute - MedStar Washington Hospital

Washington D.C., District of Columbia, 20010, United States
Mount Sinai West

New York, New York, 10019, United States
Northwestern University

Chicago, Illinois, 60611, United States
Sanger Heart & Vascular Institute

Charlotte, North Carolina, 28203, United States
Sentara Medical Group

Norfolk, Virginia, 23507, United States
St. David's Healthcare

Austin, Texas, 78705, United States
St. Mary's Hospital, Imperial College Healthcare, NHS Trust

London, W2 1NY, United Kingdom
Stanford University

Stanford, California, 94305, United States
The Methodist Hospital - Houston

Houston, Texas, 77030, United States
The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States
UPP Heart and Vascular Institute

Pittsburgh, Pennsylvania, 15213, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States
University of Florida - Gainesville

Gainesville, Florida, 32610, United States
University of Maryland Medical Center

Baltimore, Maryland, 21201, United States
University of Michigan - Cardiac Surgery

Ann Arbor, Michigan, 48109, United States
University of North Carolina

Chapel Hill, North Carolina, 27599, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
University of Rochester

Rochester, New York, 14627, United States
University of South Florida

Tampa, Florida, 33606, United States
University of Tennessee -University Vascular Surgeons

Knoxville, Tennessee, 37920, United States
University of Texas Health Science Center

Houston, Texas, 77030, United States
University of Texas Southwestern

Dallas, Texas, 75352, United States
University of Washington

Seattle, Washington, 98195, United States
University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States
Washington University School of Medicine

St Louis, Missouri, 63110, United States
Weill Cornell Medical Center

New York, New York, 10065, United States

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