RECRUITING

Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

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Conditions

Aortic Aneurysm, ThoracoabdominalAortic Aneurysm, ThoracicAortic Dissection, ThoracoabdominalThoracoabdominalAneurysmEndovascularStent-GraftAortic ArchBEVARFEVARAortaAortic Dissection

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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

Prospective, nonrandomized, single-center, two-arm study to assess the feasibility and safety and to evaluate clinical outcomes of endovascular repair of complex aortic aneurysms (thoracoabdominal aortic aneurysms and aortic arch aneurysms) in patients at high risk for open surgery.

Official Title

Feasibility, Safety, and Clinical Outcomes of Endovascular Treatment of Thoracoabdominal Aortic Aneurysms and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts

Quick Facts

Study Start:2013-11
Study Completion:2033-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02323581

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. 1. Presence of TAAA in:
  2. 1. Men with TAAA greater than or equal to 6 cm in diameter
  3. 2. Women with TAAA greater than or equal to 5 cm in diameter
  4. 3. Men with TAAA larger than 5 cm in diameter and enlarging at a rate of more than 10mm/year
  5. 4. Women with TAAA larger than 4.5 cm in diameter and enlarging at a rate of more than 10mm/year or
  6. 5. Men or women with TAAA and an iliac artery aneurysm greater than or equal to 4 cm in diameter
  7. 2. Life expectancy more than 2 years
  8. 3. Ability to give informed consent, complete pre-treatment assessments and comply with the follow-up schedule per protocol
  9. 4. Suitable arterial anatomy for endovascular TAAA repair with "TAAA device":
  10. 1. Proximal aortic landing zone:
  11. * ≥ 20mm long
  12. * ≤ 40mm and ≥ 20mm diameter in parallel aorta
  13. * free from circumferential thrombus
  14. * ≤ 60 degrees angulation
  15. 2. Mesenteric/renal aortic diameter ≥ 20mm
  16. 3. Mesenteric arteries:
  17. * ≥ 10mm long segment of healthy artery for branch attachment
  18. * Diameter ≥ 4mm and ≤ 12mm
  19. * Absence of aberrant or early branching, aneurysm or dissection
  20. 4. Renal arteries:
  21. * ≥ 10mm long segment of healthy artery for branch attachment
  22. * Diameter ≥ 4mm and ≤ 8mm
  23. * Absence of aberrant or early branching, aneurysm or dissection
  24. 5. Iliac artery access:
  25. * ≥ 6mm diameter, and absence of severe calcification and tortuosity
  26. * Or, planned creation of surgical conduit for TAAA device delivery
  27. 6. For patients with associated common iliac artery aneurysms (\>20mm diameter), adequate internal and external iliac artery landing zones and common iliac artery luminal diameter (for iliac branch device use):
  28. * ≥ 10mm long segment of healthy internal iliac artery for branch attachment
  29. * Internal iliac diameter ≥ 5mm and ≤ 12mm
  30. * External iliac diameter ≥ 6mm diameter, and absence of severe calcification and tortuosity
  31. * Minimum common iliac artery luminal diameter ≥ 14mm
  32. * Or, in patients with bilateral common iliac artery aneurysms without suitable anatomy, planned surgical bypass to maintain patency of at least one internal iliac artery
  33. 5. Patients deemed high risk for open repair (meeting one, or more, of the following criteria):
  34. 1. Age ≥ 65 year
  35. 2. Cardiac disease:
  36. * CAD (history of MI or angina with positive stress test and not revascularizable)
  37. * LV Ejection fraction \< 40%
  38. * Symptomatic CHF (NYHC Class II, III, or IV)
  39. 3. Pulmonary disease:
  40. * Home oxygen therapy
  41. * FEV1 \< 1.2 l/s
  42. * Vital capacity \< 50% predicted
  43. * PaCO2 \> 45 mm Hg or \< 60 mm Hg
  44. 4. Renal disease:
  45. * ESRD on dialysis
  46. * eGFR \< 60
  47. 5. Prior aortic surgery
  48. 6. Hostile abdomen
  49. 7. Portal hypertension (ascites or varices)
  50. 8. Coagulopathy
  1. 1. Rupture, with hypotension (systolic bp \< 90).
  2. 2. Pregnancy or breastfeeding.
  3. 3. Unwillingness or inability to comply with the follow up schedule.
  4. 4. Serious systemic or groin infection.
  5. 5. Uncorrectable coagulopathy.
  6. 6. Age \< 18 years.
  7. 7. Mycotic aneurysm.
  8. 8. Known degenerative connective tissue disease, e.g., Marfan or Ehler-Danlos Syndrome (unless proximal implantation is into a previously placed surgical graft).
  9. 9. Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, urethane or gold.
  10. 10. Participation in another in another investigational device or drug study within 1 year of treatment.
  11. 11. Unrelated concomitant major surgical or interventional procedure(s) within 30 days of treatment date (with the exception of staged procedures planned as part of treatment)
  12. 12. Body habitus that would inhibit X-ray visualization of the aorta.
  13. 13. Acute aortic dissection
  14. 14. Patients able and willing to be treated with a commercially available device or a device being evaluated in a manufacturer-sponsored pivotal study

Contacts and Locations

Study Contact

Darren Schneider, MD
CONTACT
215-614-0243
Darren.Schneider@Pennmedicine.upenn.edu
Kiera Zehner
CONTACT
(412) 737-2572
kiera.zehner@pennmedicine.upenn.edu

Principal Investigator

Darren Schneider, MD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

New York Presbyterian Hospital
New York, New York, 10022
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Darren Schneider, M.D.

  • Darren Schneider, MD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

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 Date2013-11
Study Completion Date2033-12

Study Record Updates

Study Start Date2013-11
Study Completion Date2033-12

Terms related to this study

Keywords Provided by Researchers

  • Thoracoabdominal
  • Aneurysm
  • Endovascular
  • Stent-Graft
  • Aortic Arch
  • BEVAR
  • FEVAR
  • Aorta
  • Aortic Dissection

Additional Relevant MeSH Terms

  • Aortic Aneurysm, Thoracoabdominal
  • Aortic Aneurysm, Thoracic
  • Aortic Dissection, Thoracoabdominal