Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms (NCT06657794) | Clinical Trial Compass
RecruitingNot Applicable
Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms
United States15 participantsStarted 2025-02-17
Plain-language summary
The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device:
* acutely (i.e., treatment success and technical success);
* at 30 days (i.e., the rate of major adverse events (MAE)); and
* at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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:
✓. An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) 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
Exclusion criteria
✕. Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular 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, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
✕. Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).
✕. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
✕. Patient has known allergy or intolerance to stainless steel, nitinol or gold (gold-coated tungsten).
✕. Patient has a body habitus that would inhibit X-ray visualization of the aorta
✕. Patient has a limited life expectancy of less than 1 year