Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
- Conditions
- Aorto-iliac AneurysmsIliac AneurysmsAbdominal Aortic Aneurysms
- Interventions
- Device: Zenith(R) Low Profile AAA Endovascular Graft
- Registration Number
- NCT00833924
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
- Vessels suitable for endovascular access and aneurysm repair
- Less than 18 years of age
- Inability or refusal to give informed consent
- Disease considerations that would compromise patient safety or study outcomes
- Unsuitable arterial anatomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Zenith(R) Low Profile AAA Endovascular Graft Treatment with Endovascular Graft
- Primary Outcome Measures
Name Time Method Patients With Device Failures 12-month Device success at 12-month is defined as:
Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.Patients With Major Adverse Events (MAE) 30-day MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Yale New Haven School of Med., Dept. of Vascular Surgery
🇺🇸New Haven, Connecticut, United States
University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC
🇺🇸San Francisco, California, United States
University of Michigan Hospital
🇺🇸Ann Arbor, Michigan, United States
University of Florida, Vascular Surgery
🇺🇸Gainesville, Florida, United States
Spectrum Health Butterworth
🇺🇸Grand Rapids, Michigan, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital
🇺🇸Saint Louis, Missouri, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
New York University Hospital
🇺🇸New York, New York, United States
University of Rochester, Strong Memorial Hospital
🇺🇸Rochester, New York, United States
New York Presbyterian Hospital - Cornell
🇺🇸New York, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Fairfax Inova Hospital
🇺🇸Falls Church, Virginia, United States
St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
CELT Hospital
🇷🇺Moscow, Russian Federation
St. Franziskus Hospital
🇩🇪Munster, Germany
Malmo University Hospital
🇸🇪Malmo, Sweden
Queen Mary Hospital
🇨🇳Hong Kong, China
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States