Zenith® Dissection Endovascular System

Completed · Not applicable

Conditions studied: Aortic Dissection

In brief

The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of patients with aortic dissection.

Key facts

Study ID

NCT02094300

Run by

Cook Group Incorporated

People needed

26

Starts

2007-12-01

Expected to finish

2016-11-01

Last updated by the study team

2017-02-06

Who can join

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

You may qualify if…

• Branch vessel obstruction/compromise
• Peri-aortic effusion/hematoma
• Resistant hypertension
• Persistent pain/symptoms
• Transaortic growth >5 mm within 3 months
• Transaortic diameter >40 mm.

You may not qualify if…

• Age <18 years;
• 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., less than 2 years)
• Pregnant, breast-feeding, or planning on becoming pregnant within 24 months;
• Unwilling or 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.)
• Additional medical restrictions as specified in the Clinical Investigation Plan, or
• Additional anatomical restrictions as specified in the Clinical Investigation Plan.

Where it is running

• University of Florida — Gainesville, Florida, United States
• Massachusetss General Hospital — Boston, Massachusetts, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Thomas Jefferson University Hospital — Philadephia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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