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.
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
5
sites
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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