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Endovascular Repair of Descending Thoracic Aortic Aneurysms

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00802984
First received: December 4, 2007
Last updated: December 12, 2008
Last verified: December 2008
  Purpose

The purpose of this study is to determine whether the system is safe and effective for the intended use of treating descending thoracic aortic aneurysms.


Condition Intervention Phase
Aortic Aneurysm, Thoracic
Device: Endovascular thoracic aortic aneurysm repair using TALENT TAA Stent Graft System
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endovascular Treatment of Thoracic Aortic Aneurysms Using the TALENT Stent Graft System

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Stent graft migration
  • Vessel Dissection or perforation
  • Stent graft occlusion
  • Collateral vessel occlusion
  • Aneurysm rupture
  • Aneurysm exclusion

Secondary Outcome Measures:
  • Technical success
  • Patency

Estimated Enrollment: 100
Study Start Date: January 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is a candidate for repair of a descending thoracic aortic aneurysm.
  2. Patient has one or more of the following:

    • Descending thoracic aneurysm, 5 cm in diameter or greater with proximal and distal neck suitable for stent graft placement.
    • Aneurysm is 4-5 cm in diameter but has increased in size by 0.5 cm in last 6 months.
    • Maximum diameter of aneurysm exceeds one and one-half times the transverse dimension of an adjacent normal aortic segment.
    • Post-traumatic pseudoaneurysm
    • Post-surgical pseudoaneurysm
    • Saccular aneurysm
    • Contained rupture
    • Penetrating ulcer
  3. Patient's vascular dimensions must be in the range that can be safely treated with the stent graft and extensions available to the physician at the time of the procedure.
  4. Patient has patent iliac or femoral arteries or acceptable retroperitoneal access via the abdominal aorta that allow endovascular access to the aneurysmal site with a 23F delivery catheter, typically used with a 25F introducer sheath
  5. Patient has a non-aneurysmal proximal and distal aortic neck diameter between 25 and 36 mm.
  6. Patient is American Society of Anesthesiology (ASA) grade 1 through 4.
  7. Patient has a stage of disease or condition where there is no comparable or satisfactory alternative device or therapy available for treatment; or the patient has an immediately life-threatening disease in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.
  8. Patient is able and willing to comply with 1 month, 6 month, and 1 year follow-up, and willing to comply with annual post-treatment follow-up requirements thereafter.
  9. Patient or patient's legal representative understands and has signed an Informed Consent.

Exclusion Criteria:

  1. The stent graft would have to be positioned such that there would be no flow to an artery, major branch artery or major branch arteries which supply the spinal cord.
  2. The patient has congenital abnormalities in which the placement of the stent graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated prior to treatment.
  3. Patient is pregnant.
  4. Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
  5. Patient has connective tissue disease.
  6. Patient has a hypercoagulability disorder.
  7. Patient is in acute renal failure.
  8. Patient has active systemic infection.
  9. Patient is less than 18 years old.
  10. Patient has less than a one-year life expectancy.
  11. Patient is participating in another research study involving an investigational agent for the treatment of Descending Thoracic Aortic Aneurysms.
  12. Patient has other medical, social or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
  13. Patient is unwilling or unable to return for or comply with follow-up visit schedules.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00802984

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Christopher K Zarins MD Stanford University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00802984     History of Changes
Other Study ID Numbers: SU-11092007-868, IRB Protocol Number 77836
Study First Received: December 4, 2007
Last Updated: December 12, 2008
Health Authority: United States: Food and Drug Administration
USA:External Monitoring Entity

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014