Aortic Aneurysm, Abdominal, Thoracic Aneurysm
Conditions
Keywords
Aortic Aneurysm, Abdominal [C14.907.055.239.075], Thoracic Aneurysm
Brief 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
Detailed description
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 the patient requires a single stage endovascular repair. A separate subgroup analysis of patients undergoing procedures with off-the-shelf devices will be performed.
Interventions
DEVICEFenestrated CMD
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.
DEVICEType I - III TAAA
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.
DEVICEArch cohort
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.
Sponsors
Carlos Timaran
Cook Research Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is divided into three groups, as follows: Patients with complex abdominal aortic aneurysms, including juxtarenal, suprarenal, and type IV thoracoabdominal aneurysms, will be enrolled in the fenestrated-CMD group. Patients with type I-III thoracoabdominal aneurysms will be enrolled in the type I-III TAAAs groups and will be eligible for custom-made/ off-the-shelf branched devices. Patients with high surgical risk with aortic arch aneurysms treated by patient-specific stent-grafts with one to three inner branches or a scallop.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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 commercially available endografts. 5. Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria. General
Exclusion criteria
A patient must be excluded from the clinical investigation if any of the following are true: 1. Age \<18 years 2. Life expectancy \<2 years 3. Pregnant, breastfeeding, or planning on becoming pregnant within 60 months; 4. Inability or refusal to give informed consent by the patient or a legally authorized representative; 5. Unwilling or unable to comply with the follow-up schedule 6. Prior surgical or interventional procedure within 30 days of the anticipated date of the fenestrated procedure, except for 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. 7. Participation in another clinical or device trial, except 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 a 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. 8. Patients with ruptured aortic aneurysm requiring urgent or emergent repair, except patients with contained, stable ruptures with anatomy suitable for an off-the-shelf design. 9. Patients who meet anatomical criteria for commercially available aortic stent-grafts according to the proposed instructions for use of these devices. Medical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate safety endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices. | 30 days | Primary safety will be defined as the proportion of subjects who experience a major adverse event (MAE) at 30-days or during hospitalization if this exceeds 30 days. |
| Evaluate effectiveness endovascular treatment of juxtarenal, suprarenal, thoracoabdominal and arch aortic aneurysms using fenestrated/branched investigational devices. | 12-months | For primary effectiveness endpoint, treatment success will be analyzed as the proportion of patients to achieve treatment success at 12-months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Grafts deployed at intended site with successful and patent stenting of target vessels (technical success) | 30 days | Technical success is defined as successful access of the aneurysm site and deployment of endovascular graft in the intended location. The endovascular graft and all vessels targeted with fenestrations must be patent at the time of deployment completion as evidenced by intraoperative angiography. |
| Number of Major adverse events | 5 years | Major adverse events are defined as the occurrence of any of the following: death, aneurysm rupture, or conversion to open surgical repair; Q wave myocardial infarction (MI); cardiac ischemia requiring intervention; renal failure requiring dialysis; bowel obstruction or bowel ischemia requiring intensification of medical therapy or surgical therapy; aorto-enteric fistula; stroke; paralysis. |
| Number of participants with adverse events from the use of bare metal stents as a measure of safety | 5 years | When bare metal balloon expandable or self-expandable stents are required to be used distally to covered stents, target vessel events (kink, stenosis or occlusion) will be analyzed separately at 30 days, 6 months and annually up to five years. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCarlos H. Timaran, MD
Emory University
Outcome results
None listed