Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the use of an investigational device called the ValiantTM Visceral Manifold Thoracoabdominal Stent Graft System for the repair of thoracoabdominal aortic aneurysms (TAAA), which is a balloon-like bulge in the aorta (major artery leading away from your heart) that originates in your chest and extends to your abdomen and also includes the branch arteries that supply blood to the liver, spleen, intestine, kidneys and other organs in your abdomen. The word "investigational" means the device is still being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The primary objective of the clinical investigation is to assess the use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year). Additionally, the study will assess technical success and treatment success at each follow-up interval.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Valiant™Thoracoabdominal Stent Graft System The implantation of the Valiant™ Thoracoabdominal Stent Graft System is conducted under fluoroscopic/angiographic guidance |
Device: Valiant™Thoracoabdominal Stent Graft System
The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Proportion of subjects experiencing a major adverse event through 30 days [30 Days]
Proportion of the study subjects with treatment success at 1 year. The data will be presented as quality outcomes, with the number of study subjects who experience treatment success compared to the overall patient population.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
A patient may be entered into the study if the patient has at least one of the following:
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An aneurysm with a maximum diameter of > 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
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Aneurysm with a history of growth > 0.5 cm in 6 months
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Saccular aneurysm deemed at significant risk for rupture
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Symptomatic aneurysm greater than 4.5 cm
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Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
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Proximal landing zone for the thoracic bifurcation stent graft that has:
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≥ 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm
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Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold
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Minimum branch vessel diameter greater than or equal to 5 mm
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Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
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Life expectancy: > 1 year
Exclusion Criteria:
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Patient is a good candidate for and elects for open surgical repair
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Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
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Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
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Unwilling to comply with the follow-up schedule
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Inability or refusal to give informed consent
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Urgent or emergent presentation
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Patient is pregnant or breastfeeding
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Patient has a contained rupture
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Patient has a ruptured aneurysm
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Patient has a dissection in the portion of the aorta intended to be treated
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Obstructive stenting of any or all of the visceral vessels
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Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
Medical exclusion criteria
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Known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium), polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.
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Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
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Uncorrectable coagulopathy
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Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
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Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned < 30 days of the endovascular repair
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Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
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Systemic or local infection that may increase the risk of endovascular graft infection
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Baseline creatinine greater than 2.0 mg/dL
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History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)
Anatomical exclusion criteria
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Thrombus or excessive calcification within the neck of the aneurysm
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Anatomy that would not allow maintenance of at least one patent hypogastric artery
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Anatomy that would not allow primary or assisted patency of the left subclavian artery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York University School of Medicine | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Thomas Maldonado, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-01441