Endovascular Repair of Abdominal Aortic Aneurysms
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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 |
- 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
- 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 |
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| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| 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