Zenith® Dissection Endovascular System

Status:	Active, not recruiting
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	December 2007
End Date:	February 2017

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.

Inclusion Criteria:

- Branch vessel obstruction/compromise

- Peri-aortic effusion/hematoma

- Resistant hypertension

- Persistent pain/symptoms

- Transaortic growth >5 mm within 3 months

- Transaortic diameter >40 mm.

Exclusion Criteria:

- 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.

We found this trial at

sites

University of Florida

Gainesville, Florida 32610

(352) 392-3261