Official Title
Zenith® Dissection Endovascular System in the Treatment of Patients With Acute, Complicated Type B Aortic Dissections
Brief Summary

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.

Approved for marketing
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

Eligibility Criteria

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)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

Cook Research Incorporated
NCT Number
Keywords
Aorta
Thoracic
Aortic dissection
Type B
DeBakey type III
Endovascular
MeSH Terms
Aortic Dissection