Zenih TX2; Low Profile TAA Endovascular Graft Clinical Study
Not Applicable
- Conditions
- fusiform or saccular aneurysms
- Registration Number
- JPRN-UMIN000005576
- Lead Sponsor
- Cook Japan Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
<General Exclusion Criteria> 1) Less than 20 years of age 2) Life expectancy less than 2 years 3) Pregnant or breastfeeding or planning on becoming pregnant within 60 months 4) Unwilling to company with the follow-up schedule 5) Inability or refusal to give informed consent 6) Less than 30 days beyond primary endpoint for other investigative drug or device 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 Device success, Procedural time, Condit usage during the procedure, Clinical utility measures, Morbidity, including the composite rate of major adverse events, Endleak, change in aneurysm size, migration, device patency, device integrity
- Secondary Outcome Measures
Name Time Method