Endovascular Repair of Abdominal Aortic Aneurysms

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00803075
First received: December 4, 2007
Last updated: December 18, 2008
Last verified: December 2008
  Purpose

The purpose of this study is to determine if it is safe and effective to use the TALENT AAA Stent Graft System as a treatment for AAAs in patients who are also candidates for conventional surgical aneurysm repair.


Condition Intervention Phase
Aortic Aneurysm, Abdominal
Device: Endovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA 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: TALENT Endoluminal Stent Graft System for the Treatment of Abdominal Aortic Aneurysms

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Delivery success
  • Deployment success
  • Stent graft migration
  • Aneurysm exclusion
  • Stent graft patency
  • Device integrity
  • Major morbidity and mortality
  • Vessel perforation
  • Stent graft occlusion
  • Collateral vessel occlusion
  • Aneurysm rupture

Secondary Outcome Measures:
  • Technical success
  • Patency

Estimated Enrollment: 200
Study Start Date: February 2002
  Eligibility

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

Inclusion Criteria:1. Patient has one of the following:

  • Aneurysm >4 cm in diameter, or an aneurysm that has increased in size by 0.5 cm in the last 6-months
  • Aneurysm is 1.5 times larger than the diameter of the normal infrarenal aorta or symptomatic
  • Aneurysm is saccular
  • Penetrating ulcer 2. Patient's vascular dimensions must be in the range that can be safely treated with the stent graft available to the physician at the time of the procedure.

    3. Patient has endovascular access to the aneurysmal site with the Introducer Sheath or Delivery Catheter of the appropriate ize device chosen for treatment.

    4. Patient has anatomic characteristics suitable for endovascular repair. 5. Patient has an immediate life-threatening disease of the abdominal aorta 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.

    6. Patient is American Society of Anesthesiology (ASA) grade 1 through 4. 7. Patient is able and willing to comply with 3 month, 6 month, 1 year and every year thereafter post treatment follow-up requirements.

    8. Patient or patient's legal representative understands and has signed an Informed Consent.
 Exclusion Criteria:1. Patient is pregnant or nursing. 2. Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.

    3. Patient has connective disease. 4. Patient is hypercoagulable. 5. Patient has active systemic infection. 6. Patient is less than 18 years old. 7. Patient has less than a one-year life expectancy. 8. Patient is unwilling or unable to return for follow-up visits.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803075

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
Sub-Investigator: Jason T. Lee Stanford University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00803075     History of Changes
Other Study ID Numbers: SU-11092007-864, IRB Protocol 78033
Study First Received: December 4, 2007
Last Updated: December 18, 2008
Health Authority: United States: Food and Drug Administration
USA:External Monitoring Entity

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

ClinicalTrials.gov processed this record on May 21, 2013