Endovascular Repair With Fenestrated TREO Stent-Graft System in AAA
ConditionAbdominal Aortic Aneurysms (AAA)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBolton Medical
About this trial
The goal of this clinical trial is to learn if the Fenestrated TREO Stent-Graft System works to treat abdominal aneurysms in adults. An abdominal aneurysm is a bulge in the main blood vessel (the aorta) which carries blood from the heart, through the chest and abdomen. It will also learn about the safety of Fenestrated TREO Stent-Graft System.
The main question it aims to answer is: Can the the Fenestrated TREO Stent-Graft System be used to treat participants with a specific type of abdominal aneurysm called a juxtarenal abdominal aortic aneurysm?
Participants will: Have the the Fenestrated TREO Stent-Graft System implanted via an endovascular surgical procedure and visit the hospital for a follow up period of 5 years, for checkups, tests and imaging scans.
Eligibility criteria
Qualifiers
18 years or older at the time of consent
Life expectancy is greater than 2 years
Maximum aneurysm diameter of ≥5.5 cm for male ( ≥5.0 cm for female) or
Maximum AAA diameter exceeding two times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements (or saccular aneurysm that warrants treatment in the opinion of the investigator) or
Disqualifiers
Pregnant or lactating
Existing endovascular graft in the treated segment intended to be repaired with the Fenestrated TREO Stent-Graft System
Dissection in abdominal aorta, ruptured aneurysm, or symptomatic aneurysm (as determined by treating physician)
Implant procedure as planned does not allow for at least one patent hypogastric artery left intact, unless both are occluded on pre-op imaging.
Trial design
Treatments tested in this trial
- Fenestrated TREO Stent Graft System
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov