Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections
- Conditions
- Aortic Dissection
- Registration Number
- NCT02464943
- Lead Sponsor
- Cook Research Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Not provided
Exclusion Criteria
- < 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)
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
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