Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrate… (NCT02266719) | Clinical Trial Compass
By InvitationNot Applicable
Clinical Outcomes and Radiation Safety After Endovascular Repair of Complex AAAs Using Fenestrated- Branched Devices
United States625 participantsStarted 2014-12-01
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Juxtarenal or suprarenal AAA, type I-IV thoracoabdominal aortic aneurysms or aortic arch aneurysms or dissections with diameter ≥5.0 cm in diameter or 2 times the normal aortic diameter;
✓. Aneurysm with history of growth ≥0.5 cm/year;
✓. Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation.
✓. Patients that are not eligible for treatment with commercially available endografts.
✓. Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.
Exclusion criteria
✕. Age \<18 years;
✕. Life expectancy \<2 years;
✕. Pregnant, breast-feeding, or planning on becoming pregnant within 60 months;
✕. Inability or refusal to give informed consent by the patient or a legally authorized representative;
What they're measuring
1
Evaluate safety endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices.
Timeframe: 30 days
2
Evaluate effectiveness endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices.
Timeframe: 12-months
Trial details
NCT IDNCT02266719
SponsorUniversity of Texas Southwestern Medical Center
✕. Unwilling or unable to comply with the follow-up schedule;
✕. Prior surgical or interventional procedure within 30 days of the anticipated date of the fenestrated procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, thoracic endovascular aortic aneurysm repair for proximal aneurysms, elephant trunk repair), to facilitate the procedure by allowing open reparation of a target artery not amenable to revascularization with the investigational device, such us an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement and alignment side stents, or to treat proximal aortic aneurysms.
✕. Participation in another clinical or device trial, with the exception of observational studies, participation in another investigational endovascular endograft protocol, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and/or use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be performed remotely from the fenestrated/branched repair (\>30 days). Participation in medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated/branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair.
✕. Patients with ruptured aortic aneurysm requiring urgent or emergent repair, with the exception of patients with contained, stable ruptures with anatomy suitable for an off-the-shelf design.