The physician modified endograft is intended for treating complex, pararenal, juxtarenal and thoracoabdominal aortic aneurysms requiring coverage of renal arteries, the superior mesenteric artery or the celiac trunk in high-risk patients who do not have an option for endovascular repair with an FDA approved endograft and have an appropriate anatomy. There will be one investigational site with a total of 40 subjects to be enrolled. Time to complete enrollment will be 24 months and the subject follow-up time will be five years from last subject enrollment.
The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at one year. The subjects will be followed at one month, six months, one year, and yearly thereafter for a total period of five years. Subjects will be followed up clinically for life. Clinical exam follow up may be phone or video visit with CT scan evaluation and duplex ultrasound as needed. The proportion of treatment group subjects that achieve and maintain treatment success annually to five years will be investigated.
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 is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form
Aortic aneurysm with diameter ≥ 5.5cm
Patient has a mycotic aneurysm
Patient has a ruptured aneurysm requiring urgent or emergent repair
Patient has a systemic or local infection that may increase the risk of graft infection
Patient has a body habitus that would inhibit X-ray visualization of the aorta.
Single group
Endovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).
DeviceModification * Deploy the graft on the sterile, surgical table * Mark out on the graft the locations of the fenestrations on the graft adjusting as necessary * Using handheld electrocautery, fashion the fenestration in the appropriate location on the moistened graft material in order to prevent inadvertent progression of the fenestration size * If the fenestration is going to remain as such, then a snare is used to fashion the marker on the fenestration with 5-0 stitch * If the fenestration is going to be made into a branch, then an appropriately sized, self-expanding stent is beveled and fashioned to be 15 mm long and sewn to the fenestration in addition to a snare with the 5-0 stitch * Two orientation markers are placed at the proximal edge and distal edge of the graft consisting of portions of the snare sewn to the anterior portion of the graft in a J fashion with a 5-0 stitch
The Primary Safety Endpoint (Freedom from major adverse events [MAE])
Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.
Primary effectiveness endpoint
Treatment success is defined as a composite of technical success and freedom from the following: * Aneurysm enlargement \[i.e., \>5mm as compared to any previous CT measure using orthogonal (i.e, perpendicular to the centerline) measurements\] * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events)
Technical success
Technical success and the individual components of technical success: * Successful delivery * Deployment at the intended implantation site * Patency of all endovascular graft and stent components * Absence of device deformations requiring unplanned placement of an additional device * Absence of inadvertent occlusion of aorta or aortic branch vessels * Successful withdrawal of delivery systems
The individual components of the primary safety endpoint at 30 days or during hospitalization if this exceeds 30 days
* All-cause mortality * Myocardial infarction * Respiratory failure requiring prolonged (\>24 hours from anticipated) mechanical ventilation or reintubation * Renal function decline resulting in \>50% reduction in baseline eGFR or new-onset dialysis * Bowel ischemia requiring surgical resection or not resolving with medical therapy * Major stroke * Paraplegia
Follow-up outcomes
The following at each follow-up interval: o Treatment success and the individual components of treatment success including freedom from the following: * Aneurysm sac changes (i.e enlargement, shrinkage, no change) * Aneurysm-related mortality * Aneurysm rupture * Conversion to open repair * Secondary intervention for migration, type I and III endoleaks, device integrity failure (i.e., fracture), and patency-related events (i.e., device stenosis or occlusion and embolic events). * Renal failure * All-cause mortality * Endoleaks * Device integrity failure (e.g., fracture) * Patency-related events (i.e., device stenosis or occlusion and embolic events) * Other device-related events
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
University of California, San Diego
Collaborator
