Endovascular Repair of Abdominal Aortic Aneurysms

Study Overview
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Brief Summary
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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
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TALENT Endoluminal Stent Graft System for the Treatment of Abdominal Aortic Aneurysms

Conditions
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Aortic Aneurysm, Abdominal

Intervention / Treatment
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* Device: Endovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA Stent Graft System


Participation Criteria
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Eligibility Criteria
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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.&#xA; 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Endovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA Stent Graft System|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success |  |  | 
| Patency |  |  |