Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
The HDH device is intended for creating sutureless vascular anastomosis in various blood vessels. The HDH device consists of four parts: an elastic tube (graft), docking head (anastomotic device), inversion device (connects the vascular graft to HDH) and measuring device. This study was design in order to evaluate the safety and efficacy of using HDH device and method an innovative anastomotic device for sutureless aortic anastomosis in patient diagnosed with abdominal aneurysm or Aorto-iliac aneurysm.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis|
- To establish safety of using the HDH device for creating sutureless aortic anastomosis. Safety will be established by lack of serious adverse events. [ Time Frame: within 1 month ] [ Designated as safety issue: Yes ]
- Time to complete the anastomosis [ Time Frame: during the surgery ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Aortic anastomosis surgery will be conducted using HDH device.
sutureless vascular anastomosis