Thoracoabdominal Aneurysms
Conditions
Keywords
Thoracoabdominal Aneurysms, Endovascular, Ps-ide, Early Feasibility, Aneurysm, Aortic Aneurysm, Thoracic, Aortic Aneurysm, Aortic Diseases, Cardiovascular Diseases, Vascular Diseases, Pararenal aneurysm, Juxtarenal aneurysm, Aortic dissection, Short neck infrarenal aneurysm, Type 4 thoracoabdominal, TAAA
Brief summary
The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device to repair thoracoabdominal aortic aneurysms in patients having 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 of the clinical investigation Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary stent graft system to repair thoracoabdominal aortic aneurysms in patients having 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
Visceral Manifold and Thoracic Bifurcation Endovascular stent graft system
DEVICEUnitary Manifold
Unitary Manifold Endovascular stent graft system
Sponsors
Dakota Vascular
Sanford Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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: •≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) * 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 * Proximal landing zone for the unitary manifold stent graft: * Nonaneurysmal aortic segment including previously placed graft material (neck) with a minimum seal zone length of 3 cm * Diameter in the range of 19-32 mm * Iliac artery or aortic distal fixation site 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
General exclusion * Patient is a good candidate for and elects for open surgical repair * Can be treated in accordance with the instructions for use with a legally marketed * Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site * Unwilling to comply with the follow-up schedule * Inability or refusal to give informed consent * Urgent or emergent presentation * Patient is pregnant or breastfeeding * Patient has a contained rupture * Patient has a ruptured aneurysm * Patient has a dissection in the portion of the aorta intended to be treated * Obstructive stenting of any or all of the visceral vessels * Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular) Medical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from major adverse events (MAEs) at 30 days | 30 days | Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success and technical success at 1 year | 1 year | Treatment success is defined as a composite of technical success and freedom from the following: * Aneurysm enlargement * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure , and patency-related events |
| Treatment success at various timepoints | 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | Treatment success and the individual components of treatment success including freedom from the following: * Aneurysm enlargement * Aneurysm-related mortality * Aneurysm rupture * Conversion to open repair * Secondary intervention for migration, type I and III endoleaks, device integrity failure, and patency-related events. * Renal failure * All-cause mortality * Endoleaks * Device integrity failure * Patency-related events * Other device-related events |
Countries
United States
Outcome results
None listed