Thoracoabdominal Aortic Aneurysm
Conditions
Brief summary
The primary objective of this study is to assess the use of the thoracic bifurcation and the visceral manifold devices in the repair thoracoabdominal aortic aneurysms in patients with appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Detailed description
The primary objective is to assess the use of the thoracic bifurcation and the visceral manifold stent graft system to repair thoracoabdominal aortic aneurysms in patients with appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year). Additionally, the study will assess technical success and treatment success at each follow-up interval.
Interventions
DEVICEValiant Thoracoabdominal Stent Graft System
This system of devices works to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments in patients with thoracoabdominal aneurysms.
Sponsors
Medtronic
NAMSA
Sanford Health
Matthew Eagleton
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Arm 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 or equal to 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 nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) and a diameter in the range of 26-42 mm * Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold * Iliac artery or aortic 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 * Age: ≥ 18 years old * Life expectancy: \> 1 year
Exclusion criteria
Primary Arm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from MAEs (at 30 Days) | 30 Days post- procedure | Major Adverse Events include: all-cause mortality within 30 days of the procedure, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke. |
| Preliminary Effectiveness (treatment and technical success) | 1- year post-procedure | Treatment success is defined as a composite of technical success and freedom from the following: * Aneurysm enlargement i.e., \>5mm as compared to any previous CT measure using orthogonal (i.e., perpendicular to the centerline) measurements * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | at each follow-up interval (five years) | Technical success and the individual components of technical success include: * Successful delivery * Deployment at the intended implantation site * Patency of all endovascular graft and stent components * Absence of device deformations requiring unplanned placement of an additional device * Absence of inadvertent covering of aortic branch vessels * Successful withdrawal |
| Treatment Success | at each follow-up interval (five years) | Treatment success and the individual components of treatment success including freedom from the following at each follow-up interval: * Aneurysm enlargement * Aneurysm-related mortality * Aneurysm rupture * Conversion to open repair * Secondary intervention for migration, type I and III endoleaks, device integrity failure (i.e., fracture), and patency-related events (i.e., device stenosis or occlusion and embolic events). * Renal failure * All-cause mortality * Endoleaks * Device integrity failure (e.g., fracture) * Patency-related events (i.e., device stenosis or occlusion and embolic events) * Other device-related events |
Countries
United States
Outcome results
None listed