Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)
The Christ Hospital
Summary
The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System 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.
Description
Patients diagnosed with TAAA have a poor medical history and require surgical intervention to extend life. Several repair techniques have been developed, but each carry risk. Open repairs are durable but have substantial perioperative mortality and postoperative morbidity. Endovascular techniques are plagued by high procedural complexity and poor branch vessel patency. Parallel techniques may have poor seal and may be prone to endoleak. In contrast, the manifold approach has circumferential seal at the proximal end of the system. It has relatively simple case planning and it has virtually no i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. A patient may be entered into the study if the patient has at least one of the following: 1. 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 2. aneurysm with a history of growth \> 0.5 cm in 6 months 3. saccular aneurysm deemed at significant risk for rupture 4. symptomatic aneurysm greater than 4.5 cm 2. Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devic…
Interventions
- DeviceMedtronic Valiant Thoracoabdominal Stent Graft System
The Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components The system is comprised of two investigational devices that include the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.
Location
- The Christ HospitalCincinnati, Ohio