Abdominal Aortic Aneurysm
Conditions
Keywords
patients will be matched based on AAA neck length and neck and iliac angulation
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.
Interventions
PROCEDUREEndovascular 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.
DEVICECook Zenith Stent-Graft
Cook Zenith AAA Endovascular Graft
DEVICETalent Stent-Graft
Talent AAA Abdominal Stent Graft System
Sponsors
Center for Vascular Awareness, Albany, New York
Study design
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute technical success, successful exclusion of the aneurysm | one year |
Countries
United States
Contacts
Primary ContactDeborah Hill, RN
Backup ContactAnita Suchdeve, RN
Outcome results
None listed