GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms

Completed · Not applicable

Conditions studied: Thoracoabdominal Aortic Aneurysm

In brief

This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.

Key facts

Study ID

NCT02528500

Run by

W.L.Gore & Associates

People needed

10

Starts

2015-11-01

Expected to finish

2023-02-01

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aortic aneurysm involving the visceral vessels requiring treatment
• Adequate access for TAMBE Device components
• Appropriate aortic anatomy to receive the TAMBE Device
• Age ≥ 18 years at the time of informed consent signature
• Male or infertile female
• The patient is considered high risk for open 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 Note: Additional Inclusion Criteria may apply

You may not qualify if…

• Prior aortic surgery
• 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 6 weeks of treatment
• Systemic infection which may increase risk of endovascular graft infection
• Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
• Participation in another drug or medical device study within 1 year of study enrollment
• 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
• 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 Note: Additional Exclusion Criteria may apply

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• The Mount Sinai Medical Center — New York, New York, United States
• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
• UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.