PMEG for Repair of Pararenal and Thoracoabdominal Aortic Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKonstantinos Dean Arnaoutakis, MD
About this trial
The primary objective is to evaluate the safety and effectiveness of surgeon modified endografts for the treatment of pararenal and thoracoabdominal aortic pathology in patients who are not candidate for traditional open repair due to comorbid issues and their anatomy is not amenable to commercially available endografts.
Eligibility criteria
Qualifiers
Provision of signed and dated informed consent form
Male or female, aged ≥18 years
Expected survival beyond 1 year following successful aneurysm repair
Anatomy that would require coverage of the celiac artery, superior mesenteric artery (SMA), and/or renal arteries if conventional, FDA-approved endograft were implanted to obtain adequate sealing zone length
Disqualifiers
Moderate-to-severe aortic neck calcification, thrombus, or tortuosity
Severe iliac stenosis, calcification, or tortuosity with no ability to perform a conduit
Proximal landing within zone 0 or 1
Inability to maintain at least one patent hypogastric artery
Trial design
Treatments tested in this trial
- PMEG
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Konstantinos Dean Arnaoutakis, MD
Lead sponsor
University of South Florida
Sponsor institution
Source ClinicalTrials.gov