Aortic Dissection
Conditions
Keywords
Aorta, Thoracic, Aortic dissection, Type B, DeBakey type III, Endovascular
Brief summary
The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.
Interventions
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.
Sponsors
Cook Research Incorporated
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Countries
United States
Outcome results
None listed