Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endovascular Repair of Abdominal Aortic Aneurysms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00803075
Recruitment Status : Completed
First Posted : December 5, 2008
Last Update Posted : December 22, 2008
Sponsor:
Information provided by:
Stanford University

Brief Summary:
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 or disease Intervention/treatment Phase
Aortic Aneurysm, Abdominal Device: Endovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA Stent Graft System Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TALENT Endoluminal Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
Study Start Date : February 2002

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Delivery success
  2. Deployment success
  3. Stent graft migration
  4. Aneurysm exclusion
  5. Stent graft patency
  6. Device integrity
  7. Major morbidity and mortality
  8. Vessel perforation
  9. Stent graft occlusion
  10. Collateral vessel occlusion
  11. Aneurysm rupture

Secondary Outcome Measures :
  1. Technical success
  2. Patency


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803075


Locations
Layout table for location information
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Christopher K Zarins MD Stanford University
Sub-Investigator: Jason T. Lee Stanford University

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00803075     History of Changes
Other Study ID Numbers: SU-11092007-864
IRB Protocol 78033
First Posted: December 5, 2008    Key Record Dates
Last Update Posted: December 22, 2008
Last Verified: December 2008

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