Repair of Thoracoabdominal Aortic Aneurysms
Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)
The Christ Hospital
15 participants
Aug 1, 2017
INTERVENTIONAL
Conditions
Summary
The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.
Eligibility
Inclusion Criteria27
- A patient may be entered into the study if the patient has at least one of the following:
- 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
- aneurysm with a history of growth \> 0.5 cm in 6 months
- saccular aneurysm deemed at significant risk for rupture
- symptomatic aneurysm greater than 4.5 cm
- 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.
- Proximal landing zone for the thoracic bifurcation stent graft that has:
- ≥ 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.
- 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.
- Minimum branch vessel diameter ≥ 5 mm.
- 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.
- Patient is ≥ 18 years of age.
- Patient has a life expectancy \> 1 year.
- Patient that meets the criteria for inclusion in the primary study arm but has one or more of the following criteria which would exclude them from the primary study arm:
- Patient has a minimum branch vessel diameter less than 5 mm.
- Patients presents urgently or emergently.
- Patient has a contained rupture.
- Patient has a ruptured aneurysm.
- Patient has a type B dissection (subacute or chronic) in the portion of the aorta intended to be treated.
- Patient has poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular).
- Patient's baseline creatinine greater than 2.0 mg/dL.
- Patient's anatomy that would not allow for maintenance of at least one hypogastric artery.
- Patient's anatomy that would not allow for primary or assisted patency of the left subclavian artery.
- Or
- Patient that meets the criteria for inclusion in the primary study arm and:
- Would not be eligible for the primary study arm per a documented reason other than those outlined above, and
- Per the opinion of the Principal Investigator, with concurrence of the IRB, alternative therapies are unsatisfactory and the probable risk of using the investigational device is no greater than the probable risk from the disease or condition.
Exclusion Criteria25
- Patient is a good candidate for and elects open surgical repair.
- Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis.
- Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site.
- Patient is unwilling to comply with the follow-up schedule.
- Patient is unable or refuses to give informed consent.
- Urgent or emergent presentation.
- Patient is pregnant or breastfeeding.
- Patient has a contained rupture.
- Patient has a ruptured aneurysm.
- Patient has a dissection in the treated portion of the aorta.
- Obstructive stenting of any or all of the visceral vessels.
- Poor performance status including 2 major system failures (cardiovascular, renal, hepatobiliary, neuromuscular).
- Patient has 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.
- Patient has known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.
- Patient has an uncorrectable coagulopathy.
- Patient has a body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment.
- Patient has had a major surgical or interventional procedure. unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair.
- Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina).
- Patient has a systemic or local infection that may increase the risk of endovascular graft infection.
- Baseline creatinine greater than 2.0 mg/dL.
- History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome).
- Thrombus or excessive calcification within the neck of the aneurysm.
- Anatomy that would not allow maintenance of at least one patent hypogastric artery.
- Anatomy that would not allow primary or assisted patency of the left subclavian artery.
- Expanded Selection Criteria:
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Interventions
The Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components The system is comprised of two investigational devices that include the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.
Locations(1)
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NCT03111459