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

Not Applicable

Completed

• Conditions: Vascular Disease; Atherosclerosis
• Interventions: Device: HDH

• Registration Number: NCT00805831
• Lead Sponsor: HDH Medical Ltd

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), 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-04
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	HDH	Aortic anastomosis surgery will be conducted using HDH device.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Time to complete the anastomosis	during the surgery

Trial Locations

Locations (1)

Barzilai Medical center; 🇮🇱 Ashkelon, Israel