This trial is active, not recruiting.

Condition thoracoabdominal aortic aneurysm
Treatment gore® excluder® thoracoabdominal branch endoprosthesis
Sponsor W.L.Gore & Associates
Start date November 2015
End date June 2016
Trial size 10 participants
Trial identifier NCT02528500, AAA 13-02


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
gore® excluder® thoracoabdominal branch endoprosthesis
Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)

Primary Outcomes

Absence of the following procedural safety events: Death, Stroke, Myocardial Infarction, Bowel Ischemia, Paraplegia, Respiratory Failure, Renal Failure, Procedural Blood Loss ≥1000 mL
time frame: Absence of procedural safety events through 30 days post procedure

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Aortic aneurysm involving the visceral vessels requiring treatment 2. Adequate access for TAMBE Device components 3. Appropriate aortic anatomy to receive the TAMBE Device 4. Age ≥ 18 years at the time of informed consent signature 5. Male or infertile female 6. The patient is considered high risk for open 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 Note: Additional Inclusion Criteria may apply Exclusion Criteria: 1. Prior aortic surgery 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 6 weeks of treatment 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 another drug or medical device study within 1 year of study enrollment 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. Known sensitivities or allergies to the device materials 14. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin 15. Patient has body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta 16. Renal Insufficiency Note: Additional Exclusion Criteria may apply

Additional Information

Official title Early Feasibility Assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms Involving the Visceral Branch Vessels
Principal investigator Michel Makaroun, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by W.L.Gore & Associates.