The purpose of this study is to assess the effects of a physician-modified endovascular graft (PMEG) for juxtarenal aortic aneurysms by collecting data on its performance. Participants in the study will undergo surgery to repair their juxtarenal aortic aneurysm using the PMEG device. After the surgery, participants will attend several follow-up visits to monitor their recovery and the device's effectiveness. These follow-up visits will take place at hospital discharge, then at 1 month, 6 months, 12 months, and once a year for up to 5 years after surgery.
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
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
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).
Single group
Endovascular Aneurysm Repair with Physician Modified Endograft
DeviceThe surgeon will make an incision to access the femoral artery and insert a thin wire to guide the catheter to the juxtarenal aortic aneurysm. The main graft will be modified by hand to match the participant's anatomy, then reloaded and guided through the artery to the aorta. Once in place, the graft will be deployed, and additional stents will be inserted into vital arteries that supply the kidneys and bowels. Two smaller grafts will be placed into the iliac arteries.This allows blood to flow to the target organs and legs, protecting the aneurysm from rupture. All catheters will then be removed, leaving the graft in place, and the incisions will be closed.
All Cause Mortality
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including all-cause mortality.
Myocardial Infarction
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including myocardial infarction.
Stroke
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including stroke.
Renal Failure
The primary safety endpoint is defined as the proportion of subjects who experience a Major Adverse Event (MAE) within 30 days of the index procedure, including renal failure.
Mortality
Secondary safety endpoints will be evaluated at 30 days, 6 months, \& 12 months following the initial implant procedure and annually through 5 years, including mortality.
Aneurysm related mortality
Secondary safety endpoints will be evaluated at 30 days, 6 months, \& 12 months following the initial implant procedure and annually through 5 years, including aneurysm related mortality.
Aneurysm Rupture
Secondary safety endpoints will be evaluated at 30 days, 6 months, \& 12 months following the initial implant procedure and annually through 5 years, including aneurysm rupture.
Major Adverse Events (MAE)
Secondary safety endpoints will be evaluated at 30 days, 6 months, \& 12 months following the initial implant procedure and annually through 5 years, including major adverse events.
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Cali Johnson
Lead sponsor
University of Utah
Sponsor institution
