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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Medtronic Valiant Thoracoabdominal Stent Graft System
DeviceThe 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.
Treatment groups
15 Participants
are divided into 2 treatment groupsGroup A: Primary Study ArmExperimental treatment 1 intervention
Group B: Expanded Selection ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of subjects free from major adverse events
major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Time frame
30 daysSecondary outcomes
1
Treatment Success at follow-up intervals
Treatment success includes freedom from: aneurysm enlargement, aneurysm related mortality, aneurysm rupture, conversion to open repair, secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency related events, renal failure, all-cause mortality, endoleaks, device integrity failure, patency related events and other device related events.
Time frame
1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Christ Hospital
Lead sponsor
Medtronic
Collaborator
Source ClinicalTrials.gov