Repair of Thoracoabdominal Aortic Aneurysms
ConditionThoracoabdominal Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Christ Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Patient is unwilling to comply with the follow-up schedule.
Trial design
Treatments tested in this trial
- Medtronic Valiant Thoracoabdominal Stent Graft System
Treatment groups
15 Participants
are divided into 2 treatment groupsSponsors and collaborators
The Christ Hospital
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov