Endovascular Grafts for Aortic Aneurysm
Trial Summary
What is the purpose of this trial?
The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Complex Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be high risk candidates for open surgical repair, have limited or no other options for on label treatment with an FDA approved device, and having appropriate anatomy.
Eligibility Criteria
This trial is for high-risk patients with complex aortic aneurysms who can't undergo open surgery and lack other FDA-approved treatment options. Eligible participants must have signed consent, be at risk of rupture or symptomatic, have accessible arteries for the procedure, and meet specific aneurysm size criteria.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms
Initial Follow-up
Participants are monitored for major adverse events and treatment success at 30 days post-procedure
Extended Follow-up
Participants are monitored for safety and effectiveness at 6 months, 12 months, and annually up to 5 years
Treatment Details
Interventions
- Physician Modified Aortic Endograft
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Who Is Running the Clinical Trial?
Akhilesh Jain
Lead Sponsor