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

Center for Vascular Awareness, Albany, New York

Status: Unknown

Conditions: Abdominal Aortic Aneurysm

Treatments: Device: Talent Stent-Graft; Procedure: Endovascular Repair of the abdominal aorta; Device: Cook Zenith Stent-Graft

Study type: Interventional

Funder types: Other

Identifiers

NCT00922454

001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Talent Stent-Graft

Experimental group

Treatment:

Procedure: Endovascular Repair of the abdominal aorta

Device: Talent Stent-Graft

Cook Zenith Stent-Graft

Experimental group

Treatment:

Device: Cook Zenith Stent-Graft

Procedure: Endovascular Repair of the abdominal aorta