A Single-Arm, Single-Center, Non-Randomized, Prospective Clinical Study to Evaluate the Safety and Effectiveness of Physician Modified Endograft for Complex Abdominal and Thoracoabdominal Aortic Aneurysm Repair
University of California, Davis
Summary
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.
Description
The devices that will be used are Cook Medical © devices designed and approved for thoracic aortic and perivisceral aortic disease. These devices are all constructed of full-thickness woven polyester fabric sewn to self-expanding stainless steel or nitinol Cook-Z stents with braided polyester and monofilament polypropylene suture. The grafts are available in a straight or tapered configuration, both of which are fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. These include Zenith TX2 Dissection Endovascular Grafts, The Zeni…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
---Inclusion criteria--- 1. Patient is \> 18 years of age 2. 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) 3. Patient is able and willing to sign an Institutional Review Board (IRB) approved Informed Consent Form 4. Patient has a complex, juxtarenal, pararenal or thoracoabdominal abdominal aortic aneurysm (Extent I-V) that meets at least one of the following: * Aortic aneurysm with diameter ≥ 5.5cm * Aortic aneurysm with a history of growth ≥0.5cm in the last 6 months * Symptom…
Interventions
- DeviceEndovascular Treatment of Complex abdominal or Thorocoabdominal aneurysms (TAAA).
Modification * 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
Location
- University of California San DiegoSan Diego, California