Gore Excluder Research
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
About
Protocol Description
This is a prospective, non-randomized, multicenter study with two independent arms to assess the safety and effectiveness of the TAMBE Device in the treatment of thoracoabdominal and pararenal aortic aneurysms. The two arms include patients that require the TAMBE system only and those requiring the TAMBE system and a CTAG device.
Eligibility Criteria
Inclusion Criteria
- 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)
- An Informed Consent Form signed by subject or legal representative
- 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
Exclusion Criteria
- Prior open, aortic surgery of the ascending aorta or aortic arch
- Myocardial infarction or stroke within 1 year of treatment (staged or index procedure)
- Previous instance of heparin-induced thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
- Renal insufficiency (creatinine value >1.8 mg/dL, GFR <30 or patient undergoing dialysis)
Primary Investigator
Dr. Esmaeel Reza Dadashzadeh is a dual board-certified vascular surgeon with a strong background in both clinical care and research. He’s currently the interim director of the Carilion Clinic Aortic Center and interim section chief of Aortic and Endovascular Surgery. In addition to his clinical roles, he’s an assistant professor of Aortic and Endovascular Surgery at Virginia Tech Carilion School of Medicine.
Dr. Dadashzadeh completed his vascular surgery fellowship at Washington University in St. Louis and his general surgery residency at the University of Pittsburgh Medical Center. He also holds a master’s in biomedical informatics from the University of Pittsburgh.
Contact Information
Yili Zhong, Ph.D.
Clinical Research Coordinator
