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

Running, not enrolling · Not applicable

Conditions studied: Thoracoabdominal Aortic Aneurysm

In brief

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)

Key facts

Study ID

NCT03728985

Run by

W.L.Gore & Associates

People needed

102

Starts

2019-06-17

Expected to finish

2030-01-01

Last updated by the study team

2026-06-05

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Keck Medical Center of USC — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Kaiser Permanente San Francisco Medical Center — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• MedStar Health Research Institute - MedStar Washington Hospital — Washington D.C., District of Columbia, United States
• University of Florida - Gainesville — Gainesville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan - Cardiac Surgery — Ann Arbor, Michigan, United States
• Essentia Health — Duluth, Minnesota, United States
• Division of Vascular Surgery - Minneapolis Heart Institute — Minneapolis, Minnesota, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Mount Sinai West — New York, New York, United States
• Weill Cornell Medical Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Sanger Heart & Vascular Institute — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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