Clinical Outcomes and Quality of Life Measures in Patients Treated for Thoracoabdominal Aortic Aneurysms with Fenestrated and Branched Stent Grafts
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 13-009409
NCT ID: NCT02089607
Sponsor Protocol Number: 13-009409
About this study
Subjects for this study will have been diagnosed with a bulge or aneurysm in their abdominal aorta, which is the blood vessel in the abdomen (belly) that supplies blood to most of the lower body including major organs and the legs.
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 the aneurysm.
The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of blood with a high risk of death and other serious complications. To avoid this risk the aneurysm will be repaired by putting a graft in place of the aneurysm. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm.
The upper portion of the graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches) that allow the graft to be located above the renal arteries without blocking blood flow to them. These small holes or branches are the investigational part of this research study. This is needed when there is not enough healthy aorta below the renal arteries. At least one artery may also be treated with an alignment stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches. The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft will be referred to as the Zenith Fenestrated-Branched System.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
General Inclusion Criteria:
- 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.
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), 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 or percutaneous aortic valve protocol, not encompassed by the IDE protocol and 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.
- 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, polytetrafluoroethylene (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.
- 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 diameter measured outer wall to outer wall of no greater than 38mm and no less than 21 mm;
- 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 physician-specified stent-graft due to excessive occlusive disease or small size not amenable to stent graft placement
- Unsuitable distal iliac artery fixation site and anatomy:
- 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
- Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) >21 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft
- Iliac artery distal fixation site <10 mm in length
- Inability to preserve at least one hypogastric artery
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.