Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms With Physician-Modified Fenestrated and Branched Stent Grafts
University of Southern California
Summary
The primary objective of this single arm, prospective feasibility study, Impact of Frailty on Clinical Outcomes of Patients Treated for Thoracoabdominal and Complex Abdominal Aortic Aneurysms with Physician-Modified Fenestrated and Branched Stent Grafts, is to assess the use of the physician-modified fenestrated/branched endografts to repair thoracoabdominal and complex aortic aneurysms in subjects having appropriate anatomy, at high risks for open repairs. 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 3 months, 6 months, 12 months, and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success). Additionally, this study will assess the degree of patient frailty before and after the aneurysm repair, as well as the association between the preoperative baseline frailty and clinical outcomes detailed above. This will help improve subject selection in identification of high risk patients who would not only suffer poor clinical outcomes, but also experience decline in their functional status.
Description
Device Description Two types of commercially approved thoracic aortic stent-grafts will be modified under the aegis of a physician-sponsored IDE protocol (G200159). The Cook (Bloomington, IN) Zenith Alpha proximal tapered mainbody thoracic stent-grafts and the Cook Zenith TX2 proximal tapered mainbody will be modified to form the fenestrated/branched aortic components. The Alpha thoracic stent-grafts are constructed of woven polyester graft sewn to discrete rows of self-expanding Nitinol Z stents. The most proximal sealing stent is located internally with fixation barbs that protrude through…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients may be included in the study if the patient has at least one of the following indications and are anatomically appropriate for treatment with fenestrated/branched stent grafts. 1. Pararenal, paravisceral, and type I to IV thoracoabdominal aortic aneurysms or chronic post-dissection aneurysms with a diameter 5cm or 2 times the normal aortic diameter. 2. Aneurysm with a history of growth ≥ 0.5cm per year. 3. Saccular aneurysms deemed at significant risk for rupture based on physician interpretation. 4. Symptomatic aneurysm without hemodynamic instability…
Interventions
- DevicePhysician Modified Endografts
Modification procedure Description of modified device is detailed in Section 3.5 of IDE. In summary, the steps involved in modification of the Zenith Alpha thoracic stent grafts are; 1. Unsheathing of the stent graft 2. Retrieval of a trigger wire from the inner cannula of the delivery system 3. Rerouting of the trigger wire along the stent graft 4. Removal of proximal barbs. 5. Creation of fenestrations and/or branch cuffs 6. Placement of radiopaque markers around the fenestrations/ branch cuffs 7. Placement of temporary and/or permanent diameter constraining ties 8. (Optional) Placement of preloaded wires through the fenestrations/branch cuffs
Location
- Keck Hospital of University of Southern CaliforniaLos Angeles, California