Repair of Thoracoabdominal Aortic Aneurysms (NCT03111459) | Clinical Trial Compass
RecruitingNot Applicable
Repair of Thoracoabdominal Aortic Aneurysms
United States15 participantsStarted 2017-08-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 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 that has:
✓. ≥ 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.
Exclusion criteria
✕. Patient is a good candidate for and elects open surgical repair.
✕. Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis.
✕. Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site.
✕
What they're measuring
1
Proportion of subjects free from major adverse events