Recruiting

Talent vs. Cook

Sponsor:

Center for Vascular Awareness, Albany, New York

Code:

NCT00922454

Conditions

Abdominal Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endovascular Repair of the abdominal aorta

Cook Zenith Stent-Graft

Talent Stent-Graft

Study Details

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.

Conditions

Abdominal Aortic Aneurysm

Study ID

NCT00922454

Start date

Jun, 2009

Status verified date

Jun, 2009

Completion date

Jun, 2011

Anticipated

Primary completion date

Jun, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Intervention Model

Crossover

Interventions and Outcome Measures

Arms

experimental: Talent Stent-Graft

experimental: Cook Zenith Stent-Graft

Interventions

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.

Cook Zenith Stent-Graft

Cook Zenith AAA Endovascular Graft

Talent Stent-Graft

Talent AAA Abdominal Stent Graft System

Primary outcome measure

  • Acute technical success, successful exclusion of the aneurysm [ Time Frame: one year ]

Central Contacts and Locations

Central contacts

Deborah Hill, RN

518 45202198hilld@albanyvascular.com

Anita Suchdeve, RN

518 452-1263suchdevea@albanyvascular.com

Locations

Albany Medical Center, 47 New Scotland Ave.

Recruiting

Albany, New York, United States, 12208

Contacts

Anita Suchdeve, RN

518-452-1263suchdevea@albanyvascular.com

Deborah Hill, RN

(518) 452-1298hilld@albanyvascular.com

More Information

Sponsor

Center for Vascular Awareness, Albany, New York

Last update posted

Jun 17, 2009

Last verified

Jun, 2009

Keywords

  • patients will be matched based on AAA neck length and neck and iliac angulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Center for Vascular Awareness, Albany, New York on 2009-06-17.