se-results survey of Matsudaito
Not Applicable
- Conditions
- Thoracic aorta aneurism or dissection
- Registration Number
- JPRN-UMIN000047562
- Lead Sponsor
- Sanyo Chemical Industries, Ltd.
- Brief Summary
<Efficacy verification> 95.6% of anastomotic sites showed hemostatic effect, and 66.7% of anastomotic sites didn't need additional hemostatic procedure, suggesting excellent hemostatic effect. <Safety verification> 94 patients defects/adverse events (incidence rate:16.3%) were reported. Without specificity on the types and occurrence/severity of the AEs, no AEs considered specific to the product. <Summary> Hydrofit is effective and safe, with no problems with the safety and efficacy in real use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 576
Inclusion Criteria
Not provided
Exclusion Criteria
not determined
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of defects and adverse events during 1 year follow-up
- Secondary Outcome Measures
Name Time Method Hemostatic effect during surgical procedure, and presence/absence of additional hemostatic procedures