Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA

  • STATUS
    Recruiting
  • End date
    Sep 26, 2029
  • participants needed
    20
  • sponsor
    David P. Kuwayama
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Updated on 26 April 2022
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Summary

The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.

Description

This study is a prospective, two-arm, traditional feasibility study of a physician modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft base device in adult patients meeting traditional size criteria for open surgical treatment of thoracoabdominal aortic aneurysms (TAAAs). Patients meriting surgical treatment of their aneurysm that also meet inclusion and exclusion criteria will be eligible for enrollment. Patients will be followed for 5 years post procedure. Major adverse events (MAEs) will also be recorded by the Sponsor-Investigator (S-I) and will be monitored by a locally appointed Data Monitoring Committee, Dartmouth-Hitchcock Health and the D-HH Human Research Protection Program IRB/IEC, and the FDA.

Details
Condition Aortic Aneurysm, Thoracoabdominal
Treatment Physician-modified aortic endograft
Clinical Study IdentifierNCT02989948
SponsorDavid P. Kuwayama
Last Modified on26 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Must be a man or woman 50 years of age or older by the date of informed consent
Must have a thoracic, thoracoabdominal, or abdominal aortic aneurysm that necessitates coverage of one or more visceral vessels (celiac, superior mesenteric, or renals) for establishment of proximal and/or distal seal
Must have an aneurysm size that meets standard size indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta); or, in the judgment of the S-I, has aneurysm characteristics that portend a high risk of near-term rupture
Must be considered, in the judgement of the S-I, to be a high risk candidate for open surgical repair
Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft
Patient must be able to provide informed consent
Must be able to comply with the five year study assessment schedule of events
Must have a non-aneurysm-related life expectancy, in the judgement of the S-I, of greater than 2 years

Exclusion Criteria

Known or suspected mycotic aneurysm
Ruptured aneurysm with hemodynamic instability
Known connective tissue disorder
Imaging demonstrating any of the following
Lack of 20 mm non-aneurysmal proximal seal zone (in either native aorta, elephant trunk graft, or aortic arch endograft)
Lack of 15 mm non-aneurysmal distal seal zone(s) (in either native aortoiliac vessels, prosthetic aortoiliac grafts, or aortoiliac endografts)
Branch vessel target (renal, superior mesenteric, or celiac) > 10 mm in average diameter
Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene
nitinol, or gold
Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
History of anaphylaxis to contrast, with inability to prophylax appropriately
Have uncorrectable coagulopathy
Have a body habitus that would inhibit X-ray visualization of the aorta
Known to be participating in any other clinical study which may affect performance of this device
Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
Contraindication to oral antiplatelet therapy
Prisoners or those on alternative sentencing
Known systemic infection with potential for endovascular graft infection
Anticipated need for MRI scanning within 3 months of insertion of investigational product
Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient
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