Endovascular Repair of Abdominal Aortic Aneurysms

Not Recruiting

Trial ID: NCT00803075


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.

Official Title

TALENT Endoluminal Stent Graft System for the Treatment of Abdominal Aortic Aneurysms

Stanford Investigator(s)

Jason T. Lee, MD
Jason T. Lee, MD

Professor of Surgery (Vascular Surgery)

E. John Harris Jr.
E. John Harris Jr.

Professor of Surgery (Vascular), Emeritus


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

   - 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

   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.


device: Endovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA Stent Graft System

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christopher Zarins