Endovascular Repair of Abdominal Aortic Aneurysms

Stanford University

Status and phase: Completed; Phase 4

Conditions: Aortic Aneurysm, Abdominal

Treatments: Device: Endovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA Stent Graft System

Study type: Interventional

Funder types: Other

Identifiers

NCT00803075

SU-11092007-864

IRB Protocol 78033

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.
 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.

  7. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)