Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices

Not Applicable

Interventions: Device: Type I - III TAAA
Device: Arch cohort
Device: Fenestrated CMD

Brief Summary: The purpose of this study is to assess the clinical outcomes and radiation of the use of off-the-shelf and custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms in patients having appropriate anatomy. The study consists of three cohorts. The first 2 cohorts are the continuation of the current IDE study. The first cohort is aimed to assess the use of custom-made devices (CMDs) for the endovascular repair of juxtarenal, suprarenal and type IV thoracoabdominal aortic aneurysms in standard and high-risk patients having appropriate anatomy (Fenestrated-CMD cohort). The second cohort (Type I-III thoracoabdominal cohort) includes standard and high-risk patients with type I- III thoracoabdominal aneurysms that require the use of branched/fenestrated CMDs, or, in selected cases, the Zenith Thoracoabdominal Branch (Zenith® t-Branch™) device. Finally, the third cohort (the Arch cohort) will include 25 high-risk patients with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop

Detailed Description: This study is a prospective, single center, non-randomized, triple-cohort study. For the Fenestrated-CMD cohort a total of 350 patients will be enrolled. For the type I-III thoracoabdominal cohort, a total of 250 patients will be enrolled. For the Arch cohort, 25 patients will be enrolled. CMDs will be used primarily. Off-the-shelf devices will be used in urgent cases and when the waiting period for design and manufacturing of a CMD may not be considered acceptable. Staged endovascular repair will be used for type I, II and III TAAAs and for concurrent arch and TAAAs, unless the condition of the patient requires a single stage endovascular repair. A separate subgroup analysis of patients undergoing procedures with off-the-shelf devices will be performed.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Type I - III TAAA cohort	Type I - III TAAA	Patients enrolled in this arm will be implanted with the custom made/ off-the-shelfp branched devices. The device is aimed to treat type I-III TAAAs.
Arch cohort	Arch cohort	Patients enrolled in this arm will be implanted with patient-specific stent-grafts with one to three inner branches or a scallop.
Fenestrated CMD cohort	Fenestrated CMD	Patients enrolled in this arm will be implanted with the custom made fenestrated device. The device is aimed to treat complex abdominal aortic aneurysms including juxtarenal, suprarenal and type IV thoracoabdominal aneurysms.

Primary Outcome Measures

Name	Time	Method
Evaluate safety endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices.	30 days	Primary safety will be defined as the proportion of subjects who experience a major adverse event (MAE) at 30-days or during hospitalization if this exceeds 30 days.
Evaluate effectiveness endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices.	12-months	For primary effectiveness endpoint, treatment success will be analyzed as the proportion of patients to achieve treatment success at 12-months.

Secondary Outcome Measures

Name	Time	Method
Rate of Grafts deployed at intended site with successful and patent stenting of target vessels (technical success)	30 days	Technical success is defined as successful access of the aneurysm site and deployment of endovascular graft in the intended location. The endovascular graft and all vessels targeted with fenestrations must be patent at the time of deployment completion as evidenced by intraoperative angiography.
Number of Major adverse events	5 years	Major adverse events are defined as the occurrence of any of the following: death, aneurysm rupture, or conversion to open surgical repair; Q wave myocardial infarction (MI); cardiac ischemia requiring intervention; renal failure requiring dialysis; bowel obstruction or bowel ischemia requiring intensification of medical therapy or surgical therapy; aorto-enteric fistula; stroke; paralysis.
Number of participants with adverse events from the use of bare metal stents as a measure of safety	5 years	When bare metal balloon expandable or self-expandable stents are required to be used distally to covered stents, target vessel events (kink, stenosis or occlusion) will be analyzed separately at 30 days, 6 months and annually up to five years.

Locations (1): University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States