Repair of Thoracoabdominal Aortic Aneurysms

  • STATUS
    Recruiting
  • End date
    May 23, 2024
  • participants needed
    15
  • sponsor
    The Christ Hospital
Updated on 23 January 2021

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.

Description

Patients diagnosed with TAAA have a poor medical history and require surgical intervention to extend life. Several repair techniques have been developed, but each carry risk. Open repairs are durable but have substantial perioperative mortality and postoperative morbidity. Endovascular techniques are plagued by high procedural complexity and poor branch vessel patency. Parallel techniques may have poor seal and may be prone to endoleak. In contrast, the manifold approach has circumferential seal at the proximal end of the system. It has relatively simple case planning and it has virtually no ischemic time. Due to these advantages, the Investigator believes the novel proposed technique may overcome some of the current clinical risks with other approaches.

Patients who participate in this study may benefit from having a less invasive procedure compared to open repair of their thoracoabdominal aortic aneurysm. The Investigator expects the amount of discomfort, total blood loss, recovery time, and overall hospital stay to be less than open repair. Many of the patients presenting with a thoracoabdominal aneurysm are not candidates for open repair due to existing comorbidities. With the progressive nature of the disease, these patients have limited options for medical intervention and are willing to assume a higher amount of risk.

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 two custom main body grafts are the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. For a Type I or II thoracoabdominal aneurysm the proximal seal is in zone 3, for Type III and V the device seals in zone 4. 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. The smaller 16 mm limb of the thoracic bifurcation extends to the infrarenal segment to either seal in zone 9 for a Type I and V and in zone 10 for Type II and III. All other connections in the device make use of sizes that are modular and independent of patient anatomy.

The Medtronic Valiant Thoracoabdominal Stent Graft works to bifurcate aortic flow upstream of the target visceral vessels. This bifurcation has a two-fold benefit. First it allows for aortic flow to be compartmentalized into a visceral segment and an infrarenal segment providing for uninterrupted flow to the visceral vessels as well as the infrarenal segment throughout the procedure. If any of the connections cannot be made or the patient status declines during the procedure, then it can be staged and the connections can be made at a later date. Second, the upstream bifurcation encourages more favorable flow conditions in the bridging stents and target vessels which may prevent target vessel occlusion. This is due to the fact that the bifurcations are upstream providing a sweeping transition into the renal arteries that is smooth providing for relatively laminar flow conditions. The design demonstrates that more central aortic flow is obtained with this design increasing flow rates in the visceral vessels to potentially increase target vessel patency.

The device can be used as an off-the-shelf system, negating the need for lead times associated with custom-built devices. The critical sizing will need to be done with the proximal end of the thoracic bifurcation, distal landing zone in the aorta or iliac arteries, and the bridging stents. The proximal end of the thoracic bifurcation can be sized by choosing any of the available sizes of the Medtronic TAAA thoracic bifurcation stent grafts, and the sizes of the bridging stents can be manipulated by choosing any of the commercially available sizes of the Atrium iCast. The Atrium iCasts are added to the system in-vivo and connected with passive fixation which negates the need to size the main body components based on the target vessel sizes. All other connections in the device make use of sizes that are the same, independent of patient anatomy.

The deployment of this device is also independent of device alignment. Angular alignment of the thoracic bifurcation and the visceral manifold has very little impact on the outcome of the case. Longitudinal alignment is more important, but a safety factor has been built-in by calling for the distal ends of the visceral manifold to be deployed above their target vessels by 1-2 cm. The longitudinal landing should be optimized so that the graft is not landed too low that the connection with the visceral vessels is challenging to make.

Patients included in the study will undergo follow-up at one month, six months, twelve months and then annually for five years.

Details
Condition Thoracoabdominal Aneurysm
Treatment Medtronic Valiant Thoracoabdominal Stent Graft System
Clinical Study IdentifierNCT03111459
SponsorThe Christ Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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)
Medical Exclusion Criteria
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)
Anatomical Exclusion Criteria
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
Subjects who fail to meet inclusion criteria for the primary study arm may be
enrolled under an expanded selection arm if they meet the following criteria
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