Zenith® Dissection Clinical Trial

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 acute, complicate Type B aortic dissection.

Key facts

Study ID

NCT01568320

Run by

Cook Research Incorporated

People needed

73

Starts

2012-08-01

Expected to finish

2020-01-27

Last updated by the study team

2021-03-16

Who can join

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

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 Clinical Investigation Plan, 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 60 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

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Florida — Gainesville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Indiana Heart Hospital — Indianapolis, Indiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• University of Michigan Hospital — Ann Arbor, Michigan, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• New York University Hospital — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• The Methodist Hospital — Houston, Texas, United States
• Scott and White Hospital — Temple, Texas, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States
• Sentara Vascular Specialists — Norfolk, Virginia, United States
• University of Washington-Harborview Medical Center — Seattle, Washington, United States
• Jikei University School of Medicine — Tokyo, Japan

Full record on ClinicalTrials.gov

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