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 Overview

• Status: Completed
• Conditions: Atherosclerosis; Vascular Disease
• Intervention / Treatment: Device: HDH

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ashkelon, Israel, 78278
    • Barzilai Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Aortic anastomosis surgery will be conducted using HDH device.	Device: HDH; sutureless vascular anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Time to complete the anastomosis	during the surgery

Collaborators and Investigators

• Sponsor: HDH Medical Ltd
• Investigators: Principal Investigator: Boris Yofee, MD, Barzilai Medical Center, Ashkelon, Israel

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: December 9, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (ESTIMATE): December 10, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 7, 2010
• Last Update Submitted That Met QC Criteria: July 4, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: sutureless vascular bypass
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis
• Other Study ID Numbers: HDH -AAA-P-01