se of the Zenith; Dissection Endovascular System in the Treatment of Patients with Acute, Complicated Type B Aortic Dissectio
- Conditions
- Acute, Complicated Type B Aortic Dissection
- Registration Number
- JPRN-UMIN000009113
- Lead Sponsor
- Cook Research Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 67
Not provided
General Exclusion Criteria 1)Age < 18 years; 2)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); 3)Pregnant, breast-feeding, or planning on becoming pregnant within 60 months; 4)Unwilling or unable to comply with the follow-up schedule; 5)Inability or refusal to give informed consent; or 6)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.) *Additionally, there is Medical Exclusion Criteria and Anatomical Exclusion Criteria, too.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary safety endpoint will be rate of freedom from major adverse events at 30 days. The primary effectiveness endpoint will be the survival rate at 30 days.
- Secondary Outcome Measures
Name Time Method ability to deliver and deploy the device(s), clinical utility measures, major adverse events, retrograde progression of dissection, changes in true and false lumen sizes, presence of and sources for false lumen flow, extent of false lumen thrombosis, reinterventions, and device integrity