Endovascular Repair of Abdominal Aortic Aneurysms
This study has been completed.
Information provided by:
First received: December 4, 2007
Last updated: December 18, 2008
Last verified: December 2008
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.
Aortic Aneurysm, Abdominal
Device: Endovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA Stent Graft System
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||TALENT Endoluminal Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
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
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803075
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
||Christopher K Zarins MD
||Jason T. Lee
No publications provided
History of Changes
|Other Study ID Numbers:
||SU-11092007-864, IRB Protocol 78033
|Study First Received:
||December 4, 2007
||December 18, 2008
||United States: Food and Drug Administration
USA:External Monitoring Entity
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Aortic Aneurysm, Abdominal