Endovascular Repair of Abdominal Aortic Aneurysms

Phase 4

Completed

• Conditions: Aortic Aneurysm, Abdominal

• Registration Number: NCT00803075
• Lead Sponsor: Stanford University

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 aneurysm repair.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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.

  5. 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.

  6. Patient or patient's legal representative understands and has signed an Informed Consent.


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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.

2. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Major morbidity and mortality
Deployment success
Aneurysm rupture
Delivery success
Stent graft migration
Aneurysm exclusion
Stent graft occlusion
Stent graft patency
Device integrity
Collateral vessel occlusion
Vessel perforation

Secondary Outcome Measures

Name	Time	Method
Patency
Technical success

Trial Locations

Locations (1)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States