Status:
COMPLETED
Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
Lead Sponsor:
HDH Medical Ltd
Conditions:
Vascular Disease
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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), inv...
Eligibility Criteria
Inclusion
- Patient age above 18 (men and woman)
- Patient suffers from infrarenal abdominal aortic or Aorto-iliac aneurysm
- Aneurysm diameter is larger than 5cm/ its annual growth is more than 0.5cm/or iliac aneurysm size is larger than 2.5cm
- The abdominal aneurysm neck is longer than 1.5 cm
- Patient's physical condition allows performing general anesthesia
- Patient is willing to sign the informed consent and follow the study protocol.
Exclusion
- Patient Age under 18 years
- Patient's physical condition dose not allows to perform general anesthesia
- Patient's with terminal disease and life expectancy of less than 3 months
- Patient objects to the treatment or study protocol
- Anesthesiologist or personal care physician object
- Patient suffer from Supra/infrarenal AAA
- The abdominal aneurysm neck is smaller than 1.5 cm
- Aneurysm diameter is smaller than 5cm/ its annual growth is less than 0.5cm/
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00805831
Start Date
October 1 2008
End Date
June 1 2010
Last Update
July 7 2010
Active Locations (1)
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1
Barzilai Medical center
Ashkelon, Israel, 78278