Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA)
Phase 3
Completed
- Conditions
- Abdominal Aortic Aneurysm
- Registration Number
- NCT00233688
- Lead Sponsor
- Cordis Corporation
- Brief Summary
The objective of this clinical study is to assess the safety and effectiveness of the Cordis Endovascular Quantum LP™ Stent Graft System.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To compare the aneurysm-related one-year mortality rates of the stent graft patients to open surgery patients. The purpose of having an aneurysm surgically or endovascularly repaired is to prevent death from AAA. One year To compare the one-year procedure-related severe adverse event rates of the stent graft patients to open surgery patients. These events exclude aneurysm-related deaths. The endpoint for this objective will be the occurrence of any serious adverse eve One year
- Secondary Outcome Measures
Name Time Method To evaluate the occurrence of severe device-related adverse events as they relate to the cause of aneurysm exclusion failures (i.e., Type I and III endoleaks, significant AAA growth, or AAA rupture). 30 days, 6 mo, and annually up to five years To compare the rate and amount of blood products used in the stent graft procedure to open surgery. At procedure
Trial Locations
- Locations (1)
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Newark Beth Israel Medical Center🇺🇸Newark, New Jersey, United States