Prospective Evaluation of Physician Modified Endografts for Aortic Disease
ConditionAortic Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorMayo Clinic
About this trial
The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.
Eligibility criteria
Qualifiers
An aneurysm with a maximum diameter of >5.5cm in males and >5.0cm in females in 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
Disqualifiers
Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
Unwilling to comply with the follow-up schedule
Inability or refusal to give informed consent by subject or legal representative
Trial design
Treatments tested in this trial
- Physician-Modified Terumo Treo Abdominal Stent-Graft System
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov