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โ† Trials
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CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft

RecruitingNAAges 18 Years - anyAllGustavo S Oderich
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
General Inclusion Criteria: * Thoracoabdominal aortic aneurysm with a diameter โ‰ฅ 5.5 cm or 2 times the normal aortic diameter. * Aneurysm with a history of growth โ‰ฅ 0.5 cm per year. * Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation. * Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria. * Presence of thoracoabdominal aortic aneurysm meeting one of the above-mentioned criteria with unilateral or bilateral common iliac artery aneurysm with diameter โ‰ฅ 3.0-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation. General Exclusion Criteria: * Less than 18 years of age * Unwilling to comply with the follow-up schedule * Inability or refusal to give informed consent by the patient or a legally authorized representative * Pregnant or breastfeeding * Life expectancy \< 2 years * Prior open surgical or interventional procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac conduit, cervical debranching, elephant trunk repair), to facilitate the procedure by allowing open revascularization of a target artery not amenable to revascularization with the investigational device, such as an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement of alignment side stents. * Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft 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 procedure (\> 30 days). Examples include remote (\>30 days) participation in a thoracic, abdominal or iliac branch device trial, or participation in a percutaneous aortic valve trial. 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 aneurysms requiring urgent or emergent repair, with the exception of patients with contained, stable ruptures with anatomy suitable for an off-the-shelf design. Medical Exclusion Criteria: * Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, PTFE, urethane or gold * History of anaphylactic reaction to contrast material that cannot be adequately pre-medicated * Leaking or ruptured aneurysm associated with hypotension * Uncorrectable coagulopathy * Mycotic aneurysm or patients with evidence of active systemic infection. * History of connective tissue disorder (e.g vascular Ehlers Danlos, Marfans syndrome), with the exception of those patients who had prior open surgical aortic replacement, where a surgical graft would serve as landing zone for the investigational stent-graft, those who are deemed prohibitive risk for open surgical repair or connective tissue disorders with no effect of vascular system (e.g non-vascular forms of Ehlers Danlos). * Body habitus that would inhibit X-ray visualization of the aorta and its branches. Anatomical Exclusion Criteria: * Inadequate femoral or iliac access compatible with the required delivery systems. * Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral/iliac access. * Absence of a non-aneurysmal aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with: a. A diameter measured outer wall to outer wall of no greater than 42mm and no less than 21 mm; b. Parallel aortic wall with \<20% diameter change and without significant calcification and/or thrombus in the selected area of seal zone * Visceral vessel anatomy not compatible with Zenith t-Branch or patient-specific stent-graft due to excessive occlusive disease or small size not amenable to stent graft placement * Unsuitable distal iliac artery fixation site and anatomy for iliac limb extension or iliac branch device: a. Common iliac artery fixation site diameter, measured outer wall to outer wall on a sectional image (CT) \<8.0 mm with inability to perform open surgical conduit ; b. Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) \>20 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft ; c. Non-aneurysmal external liac artery distal fixation site \<10 mm in length ; d. Non-aneurysmal internal iliac artery main trunk or branch segment with length \<10mm or with inner wall diameter \<4 or \>14mm; e. Unsuitable anatomy due to inability to preserve at least one hypogastric artery Additional anatomical inclusion criteria for aortic arch devices: * Proximal aortic fixation zone: a. Native aorta or surgical graft; b. Diameter: 20-42mm; c. Proximal neck length โ‰ฅ 20mm; d. Ascending aortic length โ‰ฅ50mm; e. Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion * Distal aortic fixati
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What it tests

  • CAAA and TAAA Arm
  • Aortic Arch Aneurysm Arm
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Where

3 sites
Mayo Clinic
Rochester, United States
Baylor College of Medicine
Houston, United States
University of Texas Health Science Center at Houston
Houston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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