Zenith Stent Graft for Aortic Aneurysms and Dissections
This study is testing the safety and effectiveness of the Zenith Fenestrated-Branched System and the Zenith Arch Branch Endovascular Graft. These devices are tubular grafts made of fabric and metal stents, designed to repair bulges (aneurysms) or tears (dissections) in your aorta, the main blood vessel in your body. The grafts are inserted through arteries in your leg or groin. The study is looking at how many people die or experience major problems within 30 days after treatment. You may be able to join if you have a large aortic aneurysm or one that is growing quickly. The study aims to gather initial information for future research or product development.
- Study design
- This is an interventional study planning to enroll 760 participants. It is a feasibility study designed to gather preliminary safety and effectiveness information.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 30 days after treatment to assess death and major adverse events.
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NCT02089607
CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft
Recruiting
NAAges 18+InterventionalTreatmentGustavo S OderichInvestigator-initiated
~760 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:CAAA and TAAA ArmAortic Arch Aneurysm Arm
At a glance
Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of subjects who have died at 30 days post treatment
Measured over 30 days post treatment
+1 more outcome measured
Conditions
Where it's being run
3 sites across 2 statesTexas2
Minnesota1
Study leadership
- Gustavo S. Oderich, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.
Aneurysm with a history of growth ≥ 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 ≥ 3.0-cm or saccular morphology with no suitable landing zone proximal to iliac bifurcation.
Proximal aortic fixation zone: a. Native aorta or surgical graft; b. Diameter: 20-42mm; c. Proximal neck length ≥ 20mm; d. Ascending aortic length ≥50mm; 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 fixation zone:; a. Native aorta or surgical graft; b. Diameter: 20-42mm; c. Distal neck length ≥20mm
In the setting of an aortic dissection the following criteria must exist: a. Access into the true lumen from the groin and at least one supra-aortic trunk vessel; b. A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen; c. A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen, or surgically created; d. A true lumen size large enough to deploy the device and still gain access into the target branches
In the setting of more distal disease: a. The repair may be coupled with a thoracoabdominal branched device, infrarenal device, and/or internal iliac branch device.
Iliac anatomy must allow for the delivery of the arch branch device which is loaded within a 20F-24F sheath. Thus the iliac requirements are no different than the standard thoracic protocol. Conduits to the iliac vessels or aorta may be used if deemed necessary.
Exclusion
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.
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.
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
What this trial measures
- Number of subjects who have died at 30 days post treatment30 days post treatment
Deaths 30 days after treatment
- Number of subjects who experience a Major Adverse Event at 30 days post treatment30 days post treatment
A Major Adverse Event includes any of the following: bowel ischemia, myocardial infarction (heart attack), paraplegia, renal failure, respiratory failure, stroke, or blood loss greater than 1000 ml.