RECRUITING

Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms, thoracoabdominal aneurysms and aortic arch aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.

Official Title

Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

Quick Facts

Study Start:2014-03
Study Completion:2030-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02050113

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * A patient may be suitable for inclusion in the study if the patient has at least one of the following:
  2. 1. Aortic or aortoiliac aneurysm with diameter ≥5.5 cm
  3. 2. Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms
  4. 1. Cannot be treated with a currently available non-modified approved device
  5. 2. Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device
  6. 3. At least 18 years of age
  7. 4. Not pregnant or breastfeeding
  8. 5. Willing and able to comply with five years of follow-up
  9. 6. Willing and able to provide informed consent prior to enrollment
  10. 7. No systemic or local infection that may increase the risk of endovascular graft infection
  11. 8. High risk for open surgical repair based on any of the factors below:
  1. * Exclusion Criteria Medical Exclusion Criteria
  2. 1. Cultural objection to receipt of blood or blood products
  3. 2. Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol
  4. 3. Anaphylactic reaction to contrast that cannot be adequately pre-medicated
  5. 4. Uncorrectable coagulopathy
  6. 5. Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
  7. 6. Patient has active malignancy with life expectancy of less than 2 years
  8. 7. Patient has life expectancy less than two years
  9. 1. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
  10. 2. Proximal neck length ≤25 mm
  11. 3. Proximal neck, measured outer wall to outer wall on a sectional image (CT)
  12. 1. For use of Zenith Flex: diameter \>32 mm or \<18 mm
  13. 2. For use of Zenith TX2: diameter \>38 mm or \<24 mm (for proximal and distal neck diameter)
  14. 4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
  15. 5. Proximal neck diameter change over the length of the proximal seal zone \>4 mm
  16. 6. Proximal seal site with a circumferential thrombus/atheroma
  17. 7. Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) \<7.0 mm at any point along access length (prior to deployment)
  18. 8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) \>21 mm at distal fixation site
  19. 9. Iliac artery distal fixation site \<10 mm in length
  20. 10. Non-bifurcated segment of any artery to be stented \< 15 mm in length
  21. 11. Artery to be stented with a maximum diameter \<3 mm or \>10 mm at the vessel ostium
  22. 12. Inability to maintain at least one patent hypogastric artery

Contacts and Locations

Study Contact

Shauneen Valliere, MSN, NP
CONTACT
508-856-1767
shauneen.valliere@umassmed.edu
Andres Schanzer, MD
CONTACT
508-856-5599
andres.schanzer@umassmemorial.org

Principal Investigator

Andres Schanzer, MD
PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester

Study Locations (Sites)

UMass Memorial Health Care - University Campus
Worcester, Massachusetts, 01655
United States

Collaborators and Investigators

Sponsor: Andres Schanzer

  • Andres Schanzer, MD, PRINCIPAL_INVESTIGATOR, University of Massachusetts, Worcester

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 Date2014-03
Study Completion Date2030-03

Study Record Updates

Study Start Date2014-03
Study Completion Date2030-03

Terms related to this study

Keywords Provided by Researchers

  • Complex Aortic Aneurysms
  • Thoracoabdominal Aneurysms
  • Pararenal Aortic Aneurysms
  • Juxtarenal Renal Aneurysms
  • Endovascular Branch Graft
  • Fenestrated Stent Graft
  • Abdominal Aortic Aneurysm
  • Endovascular
  • Aortic Dissection
  • Aortic Arch Aneurysms

Additional Relevant MeSH Terms

  • Complex Aortic Aneurysms
  • Thoracoabdominal Aneurysms
  • Pararenal Aneurysms
  • Juxtarenal Aneurysms
  • Marfan Syndrome
  • Ehlers-Danlos Syndrome
  • Loeys-Dietz Syndrome
  • Aortic Arch Aneurysm