RECRUITING

Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

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Conditions

Aortic Aneurysm

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Study Overview

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Description

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.

Official Title

Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

Quick Facts

Study Start:2024-12-10
Study Completion:2031-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06501872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 95 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must be a man or woman 50 years of age or older by the date of informed consent
  2. * Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.
  3. * Must have an aneurysm size that meets standard 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)
  4. * Must be considered, in the judgement of the Investigator, to be a high- risk candidate for open surgical repair
  5. * Must commit to comply with the five-year study assessment schedule of events
  6. * Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, of greater than 2 years
  1. * Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection
  2. * Ruptured or acutely symptomatic aortic aneurysm
  3. * Known connective tissue disorder
  4. * Imaging demonstrating any of the following:
  5. * Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition)
  6. * Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac)
  7. * Branch vessel target (renal, superior mesenteric, or celiac) \< 5 mm or \> 10 mm in average diameter
  8. * Untreated left subclavian artery stenosis or occlusion
  9. * Untreated unilateral or bilateral hypogastric artery occlusion
  10. * Signs that the inferior mesenteric artery is indispensable
  11. * Have branching, duplication, aneurysm, or untreatable stenosis of the celiac, superior mesenteric artery, or renal arteries that would preclude implantation of the investigational devices
  12. * Known allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
  13. * History of anaphylaxis to contrast, with inability to prophylax appropriately.
  14. * Have uncorrectable coagulopathy
  15. * Have unstable angina
  16. * Have a body habitus that would inhibit X-ray visualization of the aorta
  17. * Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair
  18. * Known to be participating in any other clinical study which may affect performance of this - Ability to bear children
  19. * Contraindication to oral antiplatelet therapy
  20. * Prisoners or those on alternative sentencing
  21. * Known systemic infection with potential for endovascular graft infection
  22. * Anticipated need for MRI scanning within 3 months of insertion of investigational product
  23. * Candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft
  24. * Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution.

Contacts and Locations

Study Contact

Amirsadreddin Kazzazi
CONTACT
603-650-6379
Amirsadreddin.Kazzazi@hitchcock.org
Caren Saunders
CONTACT
6033-650-7985
caren.h.saunders@hitchcock.org

Principal Investigator

Bjoern D Suckow, MD
PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center

Study Locations (Sites)

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
United States

Collaborators and Investigators

Sponsor: Bjoern D. Suckow

  • Bjoern D Suckow, MD, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-10
Study Completion Date2031-09

Study Record Updates

Study Start Date2024-12-10
Study Completion Date2031-09

Terms related to this study

Keywords Provided by Researchers

  • Aortic Aneurysm

Additional Relevant MeSH Terms

  • Aortic Aneurysm