Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms

  • STATUS
    Recruiting
  • End date
    Dec 23, 2024
  • participants needed
    100
  • sponsor
    Sanford Health
Updated on 23 January 2021

Summary

The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device 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

The primary objective of the clinical investigation Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary stent graft system 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.

Details
Condition Thoracoabdominal Aneurysms
Treatment Visceral Manifold and Thoracic Bifurcation, Unitary Manifold
Clinical Study IdentifierNCT02294435
SponsorSanford Health
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
Minimum branch vessel diameter less than 5 mm
Urgent or emergent presentation
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
Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
Baseline creatinine greater than or equal to 2.0 mg/dL
Anatomy that would not allow for maintenance of at least one hypogastric artery
Anatomy that would not allow for primary or assisted patency of the left subclavian artery
Prior aneurysm repair that would involve relining of the previously placed graft material requiring placement of the investigational system in the a landing zone that expands beyond any limits of the previously placed graft material
Obstructive stenting of any or all of the visceral vessels
OR
Patient that meets 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

General exclusion
Patient is a good candidate for and elects for open surgical repair
Can be treated in accordance with the instructions for use with a legally marketed
Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
Unwilling to comply with the follow-up schedule
Inability or refusal 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 portion of the aorta intended to be treated
Obstructive stenting of any or all of the visceral vessels
Poor performance status including two major system failures (cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
Medical exclusion criteria
Known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel:Titanium), polyester, platinum-iridium, polytetrafluoroethylene (PTFE)
Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
Uncorrectable coagulopathy
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
Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
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)
Prior aneurysm repair that would involve relining of the previously placed graft material requiring placement of the investigational system in a landing zone that expands beyond any limits of the previously placed graft material
Anatomical exclusion criteria
Minimum branch vessel diameter less than 5 mm
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
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