Physician Modified Endovascular Grafts
ConditionAbdominal Aortic Aneurysms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
The primary objectives of this study are to determine whether physician modified endovascular grafts (PMEG) and specified company manufactured investigational devices are a safe and effective method of treating patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to have limited or no other options for treatment. Secondary objectives include the validation of a patient-specific, 3-D printed aortic template as a surgical planning tool for fenestrated endografting.
Eligibility criteria
Qualifiers
Patient is > 18 years of age
Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)
Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form
Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following: Abdominal aortic aneurysm >5.5 cm in diameter, Aneurysm has increased in size by 0.5 cm in last 6 months, Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment
Disqualifiers
Patient has a mycotic aneurysm or has an active systemic infection
Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
Patient has a major surgical or interventional procedure planned within +/- 30 days of the AAA repair.
Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
Trial design
Treatments tested in this trial
- Fenestrated Endovascular Graft or Company Manufactured Terumo Aortic Fenestrated TREO Endovascular Graft
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov