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The primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Full description
The primary objective of this clinical investigation is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms. While surgery remains a standard treatment for complex abdominal and thoracoabdominal aneurysms (TAAA), the tolerance of some patients to recover from such extensive and invasive open aortic reconstructions is poor. Endovascular repair may offer the opportunity to reduce patient risk with less invasive approaches, improve quality of life, and serve to reduce the cost burden. The primary technical safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.
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Inclusion and exclusion criteria
Inclusion Criteria:
Modified Inclusion Criteria
A patient may be entered into the study if the patient has at least one of the following:
Other inclusion criteria:
Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
Proximal landing zone for the thoracic bifurcation stent graft that has:
Minimum branch vessel diameter greater than 5 mm
Iliac artery distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
Patency of the four major visceral vessels (SMA, celiac, right renal, left renal)
Age: ≥ 18 years old
Life expectancy: > 1 year
Exclusion Criteria
General exclusion
Medical exclusion criteria
Anatomical exclusion criteria
Primary purpose
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2 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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