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Aortic Aneurysm Abdominal Clinical Trial
Have you or your loved ones been diagnosed with aortic aneurysm abdominal?
You may be eligible to participate in a aortic aneurysm abdominal clinical trial.
Have you or your loved ones been diagnosed with aortic aneurysm abdominal? You may be eligible to participate in a aortic aneurysm abdominal clinical trial.
Active not recruiting
Male & Female
18 Years +
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
Details for the study
Brief Title
Zenith® p-Branch® Endovascular Graft Pivotal Study
Official Title
Zenith® p-Branch® Pivotal Study
Brief Summary
The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety <br /> and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium <br /> iCAST™ covered stents in the treatment of abdominal aortic aneurysms.
Treatments and/or Procedures
Zenith® p Branch® in combination with the Atrium iCAST™ covered stents
Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Treatment Success Proportion
Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications
Study Criteria
Inclusion Criteria:
- Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
- Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
- Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic
diameter that is deemed to be at risk for rupture based upon physician interpretation
Exclusion Criteria:
- Age <18 years
- Life expectancy <2 years
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
- Inability or refusal to give informed consent by the patient or a legally authorized
representative
- Unwilling or unable to comply with the follow-up schedule
- Simultaneously participating in another investigative device or drug study. (The
patient must have completed the primary endpoint of any previous study at least 30
days prior to enrollment in this study.)
- Additional medical restrictions as specified in the Clinical Investigation Plan
- Additional anatomical restrictions as specified in the Clinical Investigation Plan