The Zenith® Dissection extended study is to collect confirmatory safety and effectivenessdata on the Zenith® Dissection Endovascular System in the treatment of acute, complicateType B aortic dissection.
Device: Endovascular Treatment (Zenith)
Instead of making a large incision in the chest, the physician makes a small incision
near each hip to insert, and guides the study device(s) into place in the aorta.
Other Name: Endovascular graft,Endovascular stent,Stent-graft
Exclusion Criteria:
- < 18 years of age
- Other medical condition(e.g., cancer, congestive heart failure) that may cause the
patient to be non-compliant with the protocol, confound the results, or is
associated with limited life expectancy (i.e., < 2 years)
- Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
- Unwilling to unable to comply with the follow-up schedule
- Inability or refusal to give informed consent
- 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)
Cooper University Hospital
Camden, New Jersey, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States