Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft

Not Applicable

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Procedure: Endovascular Repair of the abdominal aorta; Device: Cook Zenith Stent-Graft; Device: Talent Stent-Graft

• Registration Number: NCT00922454
• Lead Sponsor: Center for Vascular Awareness, Albany, New York

Brief Summary

The purpose of this study is to compare acute technical outcomes of the Talent AAA Stent Graft system versus Cook Zenith Endograft at two high volume institutions, Albany Medical Center and St. Peter's Hospital in Albany, NY.

The investigators are comparing the two devices as part of the evolution of endovascular repair (EVAR) for AAAs. The Zenith AAA Endovascular Graft received FDA approval on May 23, 2003, the Talent Abdominal Stent Graft System on April 15, 2008.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-06
• Study Start: 2009-06
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Last Update Submitted: 2009-06-16
• Study First Posted: 2009-06-17
• Last Update Posted: 2009-06-17
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• subject with abdominal aortic aneurysm, with or without iliac involvement
• iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories

Exclusion Criteria

• less than 18 years of age
• pregnant or lactating
• have contraindications for use of contrast medium or anticoagulation drugs
• are patients who have a condition that threatens to infect the graft
• are patients with sensitivities or allergies to the device materials

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Talent Stent-Graft	Endovascular Repair of the abdominal aorta	-
Cook Zenith Stent-Graft	Cook Zenith Stent-Graft	-
Cook Zenith Stent-Graft	Endovascular Repair of the abdominal aorta	-
Talent Stent-Graft	Talent Stent-Graft	-

Primary Outcome Measures

Name	Time	Method
Acute technical success, successful exclusion of the aneurysm	one year

Trial Locations

Locations (1)

Albany Medical Center, 47 New Scotland Ave.; 🇺🇸 Albany, New York, United States