Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections

APPROVED_FOR_MARKETING

Conditions studied: Aortic Dissection

In brief

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.

Key facts

Study ID

NCT02464943

Run by

Cook Research Incorporated

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• < 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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