Endovascular Repair of Abdominal Aortic Aneurysms

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

TALENT Endoluminal Stent Graft System for the Treatment of Abdominal Aortic Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803075
• Other study ID #: SU-11092007-864
• Secondary ID: IRB Protocol 780
• Status: Completed
• Phase: Phase 4
• Start date: February 2002
• Est. completion date: December 2005

Study information

• Verified date: October 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery success
Primary	Deployment success
Primary	Stent graft migration
Primary	Aneurysm exclusion
Primary	Stent graft patency
Primary	Device integrity
Primary	Major morbidity and mortality
Primary	Vessel perforation
Primary	Stent graft occlusion
Primary	Collateral vessel occlusion
Primary	Aneurysm rupture
Secondary	Technical success
Secondary	Patency