Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic Aneurysms: An Investigator-Initiated Study
University of Washington
Summary
An investigator-initiated, prospective, consecutively enrolling, non-randomized single institution clinical evaluation of the safety and effectiveness of branched and fenestrated-branched endovascular stent grafts to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic aneurysms. The study evaluates non-FDA-approved off the shelf and custom made branched and fenestrated-branched stent grafts manufactured by Cook Medical. The primary objectives of this study are to determine whether fenestrated-branched and branched endovascular grafts are a safe and effective method of treating patients with thoraco-abdominal aortic aneurysms.
Description
A branched thoracic endograft is a commercially manufactured endograft that has reinforced fenestrations or branches in the graft through which covered stent grafts can be deployed to preserve blood flow into visceral branch vessels. The branched stent graft is deployed to reline the peri-visceral abdominal aorta. Proximal and distal fixation and seal can be achieved using the branched device, additional Cook Alpha Thoracic devices and/or the Cook Zenith® Flex® device depending on the aortic anatomy. Once the aortic stent grafts are deployed, the branches are then created. Wires and catheter…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study: 1. Patient is \> 18 years of age 2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study) 3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form 4. Patient is considered by the treating physician to be at high risk of open surgical repair due to one or more major medical co-morbidities (i.e. CAD,…
Interventions
- DeviceB-TEVAR device
Implantation of the Branched Thorcoabdominal aortic anerysm device
Location
- University of Washington/Harborview Medical CenterSeattle, Washington