A Study of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms Involving the Visceral Branch Vessels
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-002850
NCT ID: NCT02528500
Sponsor Protocol Number: AAA 13-02
About this study
The purpose of this study is to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of aortic aneurysms involving the visceral branch vessels.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- 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
- Additional inclusion criteria may apply
Exclusion Criteria
- 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
- Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta
- Renal Insufficiency
- Additional exclusion criteria may apply
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bernardo Mendes, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available