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Clinical Trials in the USA / NCT03728985
Active, not recruiting Not applicable

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

NCT03728985 · tracked via the Priya Life Science USA tracker
Sponsor
W.L.Gore & Associates
Phase
Not applicable
Started
2019-06-17
Last updated
2026-09-02

Condition(s) studied

Thoracoabdominal Aortic Aneurysm

Investigational drug(s) / intervention(s)

GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: Endovascular Aortic Stent-Graft

Study summary

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)

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (44)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Mayo Clinic Arizona Scottsdale Arizona
Keck Medical Center of USC Los Angeles California
Cedars-Sinai Medical Center Los Angeles California
Kaiser Permanente San Francisco Medical Center San Francisco California
Stanford University Stanford California
MedStar Health Research Institute - MedStar Washington Hospital Washington D.C. District of Columbia
University of Florida - Gainesville Gainesville Florida
University of South Florida Tampa Florida
Emory University Hospital Atlanta Georgia
Northwestern University Chicago Illinois
Indiana University Indianapolis Indiana
University of Maryland Medical Center Baltimore Maryland
Massachusetts General Hospital Boston Massachusetts
University of Michigan - Cardiac Surgery Ann Arbor Michigan
Essentia Health Duluth Minnesota
Division of Vascular Surgery - Minneapolis Heart Institute Minneapolis Minnesota
Mayo Clinic - Rochester Rochester Minnesota
Washington University School of Medicine St Louis Missouri
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
Mount Sinai West New York New York
Weill Cornell Medical Center New York New York
University of Rochester Rochester New York
University of North Carolina Chapel Hill North Carolina
Sanger Heart & Vascular Institute Charlotte North Carolina
Duke University Medical Center Durham North Carolina
Cleveland Clinic Cleveland Ohio
The Ohio State University Wexner Medical Center Columbus Ohio
University of Pennsylvania Philadelphia Pennsylvania
UPP Heart and Vascular Institute Pittsburgh Pennsylvania
University of Tennessee -University Vascular Surgeons Knoxville Tennessee
St. David's Healthcare Austin Texas
Baylor Heart & Vascular Hospital Dallas Texas
University of Texas Southwestern Dallas Texas
Baylor College of Medicine Houston Texas
The Methodist Hospital - Houston Houston Texas
University of Texas Health Science Center Houston Texas
Sentara Medical Group Norfolk Virginia
Carilion Clinic Hospitals Roanoke Virginia
University of Washington Seattle Washington

+ 4 more sites — see the full list on the official registry below.

More W.L.Gore & Associates trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03728985 on ClinicalTrials.gov ↗ ← All trials in the USA