Carlos Timaran
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
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 t…
General Inclusion Criteria A patient is deemed suitable for inclusion in the study if the patient has at least one of the following: 1. Juxtarenal or suprarenal AAA, type I-IV thoracoabdominal aortic aneurysms or aortic arch aneurysms or dissections with a diameter ≥5.0 cm in diameter or 2 times the normal aortic diameter 2. Aneurysm with a history of growth ≥0.5 cm/year 3. Saccular aneurysm with an aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation. 4. Patients who are not eligible for treatment with…
The CMD that will be used in this IDE is structurally the same as the commercially available Zenith Fenestrated AAA Endovascular Graft. In general, the Zenith® Fenestrated AAA Endovascular Graft is a modular system constructed of full- thickness woven polyester fabric sewn to self-expanding stainless steel z-stents with braided polyester and monofilament polypropylene sutures. In this study, fenestrated grafts with up to 4 fenestrations may be used. Device implantation will be performed using standardized endovascular techniques used in the treatment of abdominal aortic aneurysms.
Device implantation will be performed using standardized endovascular techniques used in the treatment of abdominal aortic aneurysms. Devices will be implanted in patients with type I-III thoracic abdominal aneurysms. The branches in this study will be constructed as internal/external cuffs, axially oriented and either caudally or cranially directed, as necessary. The branch position will be determined by the anatomic location of the target vessels using a consistent craniocaudal and circumferential cuff position.
Arch branched devices may be designed using one of two configurations: (1) Zone 0 device with two inner antegrade branches for the innominate artery and the left common carotid artery with or without a retrograde left subclavian artery branch and (2) Zone 1-2 device with a single retrograde subclavian artery branch with double or triple wide scallop for the left common carotid artery. These devices are designed for a of proximal landing/fixation zone of at least 20 mm of healthy aortic segment or a previous graft.