Endovascular Repair of Abdominal Aortic Aneurysms

NCT00803075 | Completed Phase 4

• 2 other identifiers: SU-11092007-864IRB Protocol 78033
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm, Abdominal

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (2)

• Technical success

• Patency

Interventions

Endovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA Stent Graft System DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Patient has endovascular access to the aneurysmal site with the Introducer Sheath or Delivery Catheter of the appropriate ize device chosen for treatment.
• \. 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.
• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Christopher K Zarins MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jason T. Lee

  Stanford University

  SUB INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2007
• First Posted: December 5, 2008
• Study Start: February 1, 2002
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

US (1)