The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A physician modified Terumo Treo abdominal stent-graft system will be used during repair surgery for type II, III and IV thoracoabdominal aortic aneurysms.
Mayo Clinic
Jacksonville, Florida, United States
RECRUITINGProportion of study subjects with treatment success at 1 year
Treatment success is defined as freedom from the following: * Aneurysm enlargement: \>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) * Graft infection * Disabling Stroke * Permanent dialysis Results are reported as a percentage
Time frame: 1 year
Proportion of procedures that achieve technical success
Technical success is defined as: * Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits * Successful delivery and Deployment at the intended implantation site * Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels. * Successful withdrawal of the delivery system * Patency of all endovascular graft and stent components * Absence of device deformations requiring unplanned placement of an additional device * Absence of Type I and III endoleaks at completion angiography that extends beyond 30 days by confirmatory imaging (CTA, MRA or duplex ultrasound) Results are reported as a percentage
Time frame: 1 year
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