Clinical trial NCT00803075: Endovascular Repair of Abdominal Aortic Aneurysms
Official title: TALENT Endoluminal Stent Graft System for the Treatment of Abdominal Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Aneurysm, Abdominal
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

  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.

Primary outcomes:
measure: Delivery success
measure: Deployment success
measure: Stent graft migration
measure: Aneurysm exclusion
measure: Stent graft patency
measure: Device integrity
measure: Major morbidity and mortality
measure: Vessel perforation
measure: Stent graft occlusion
measure: Collateral vessel occlusion
measure: Aneurysm rupture
Secondary outcomes:
measure: Technical success
measure: Patency
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Christopher K Zarins MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Jason T. Lee
role: SUB_INVESTIGATOR
References: