Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis

Atherosclerosis Clinical Trial

Official title:

Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00805831
• Other study ID #: HDH -AAA-P-01
• Status: Completed
• Phase: N/A
• First received: December 9, 2008
• Last updated: July 4, 2010
• Start date: October 2008
• Est. completion date: June 2010

Study information

• Verified date: July 2010
• Source: HDH Medical Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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), 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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/

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Vascular Disease
• Vascular Diseases

Intervention

Device:
• HDH
sutureless vascular anastomosis

Locations

Country	Name	City	State
Israel	Barzilai Medical center	Ashkelon

Sponsors (1)

Lead Sponsor	Collaborator
HDH Medical Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish safety of using the HDH device for creating sutureless aortic anastomosis. Safety will be established by lack of serious adverse events.		within 1 month	Yes
Secondary	Time to complete the anastomosis		during the surgery	No