Status:
COMPLETED
Endovascular Repair of Abdominal Aortic Aneurysms
Lead Sponsor:
Stanford University
Conditions:
Aortic Aneurysm, Abdominal
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ane...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT00803075
Start Date
February 1 2002
End Date
December 1 2005
Last Update
October 8 2020
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305