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

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Acute Technical Outcomes of the Talent AAA Stent -Graft vs. Cook Zenith Stent- Graft: A Case-Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00922454
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2009
• Last updated: June 16, 2009
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2009
• Source: Center for Vascular Awareness, Albany, New York
• Contact: Deborah Hill, RN
• Phone: 518 45202198
• Email: hilld[@]albanyvascular.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Procedure:
• Endovascular Repair of the abdominal aorta
Patients will undergo or have undergone endovascular aneurysm repair which is minimally invasive approach using endoluminal placement of a stent graft. EVAR, CTA imaging, 1, 6 12 months post treatment.

Device:
• Cook Zenith Stent-Graft
Cook Zenith AAA Endovascular Graft
• Talent Stent-Graft
Talent AAA Abdominal Stent Graft System

Locations

Country	Name	City	State
United States	Albany Medical Center, 47 New Scotland Ave.	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Center for Vascular Awareness, Albany, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute technical success, successful exclusion of the aneurysm		one year	Yes