Aortic Arch Aneurysm, Aortic Arch Dissection, Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
Conditions
Keywords
aneurysm, aortic aneurysm
Brief summary
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.
Detailed description
This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development. Subjects will have been diagnosed with a bulge or aneurysm in their aortic arch and or 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 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 inside the aneurysm. The graft will be inserted through arteries in the groin (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent-graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will have a 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.
Interventions
DEVICECAAA and TAAA Arm
The Zenith Fenestrated-Branched System is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. 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 graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). One or more than one of the study devices including the Zenith® Fenestrated AAA Endovascular Graft, Zenith® t-Branch Endovascular Graft, Patient-Specific Thoracoabdominal Graft, Patient-Specific Distal Bifurcated Component, and Zenith® Branch Endovascular Graft-Iliac Bifurcation will be implanted. The arteries to the liver, intestine, and kidneys will have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
DEVICEAortic Arch Aneurysm Arm
The Zenith® Arch Branch Endovascular Graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively. The main aortic endovascular graft will be connected into the innominate artery, left common carotid artery and left subclavian artery using additional stents into the branch vessels.
Sponsors
Gustavo S Oderich
William Cook Australia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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. * 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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects who have died at 30 days post treatment | 30 days post treatment | Deaths 30 days after treatment |
| Number of subjects who experience a Major Adverse Event at 30 days post treatment | 30 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects who achieve treatment success | 12 months post treatment | Treatment success is defined by a composite endpoint, which includes all the following criteria: 1) technical success, defined as successful delivery and deployment of the custom-made endovascular graft with preservation of those branch vessels intended to be preserved; 2) freedom from type I or III endoleak; 3) freedom from stent-graft migration; 4) freedom from aneurysm enlargement \>5 mm; 5) freedom from aneurysm rupture or conversion to open repair. |
| Mean Quality of Life Measure at Various Time Points | Pre-procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | Subjects complete the Short-Form General Health Survey (SF-36) form which consists of an 11 question survey that is divided into 2 parts: physical and emotional. The scale scores range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable). |
Countries
United States
Contacts
CONTACTAndrea C Martinez, BS
CONTACTYing Huang, MD, PhD
PRINCIPAL_INVESTIGATORGustavo S. Oderich, MD
Baylor College of Medicine
Outcome results
None listed