A Study of the Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thoracoabdominal Aortic Aneurysm
- Sponsor
- Johns Hopkins University
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Freedom From Major Adverse Events (MAEs) at 30 Days
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Modified Inclusion Criteria
- •A patient may be entered into the study if the patient has at least one of the following:
- •An aneurysm with a maximum diameter of \> 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
- •Aneurysm with a history of growth \> 0.5 cm in 6 months
- •Saccular aneurysm deemed at significant risk for rupture
- •Symptomatic aneurysm greater than 4.5 cm
- •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:
- •≥ 2.5 cm of healthy/nondiseased tissue (including previously placed graft material) (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Freedom From Major Adverse Events (MAEs) at 30 Days
Time Frame: 30 days
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Secondary Outcomes
- Treatment Success at 1 Year(1 year)