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

This study has been completed.
Sponsor:
Information provided by:
HDH Medical Ltd
ClinicalTrials.gov Identifier:
NCT00805831
First received: December 9, 2008
Last updated: July 4, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Vascular Disease
Atherosclerosis
Device: HDH

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by HDH Medical Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Time to complete the anastomosis [ Time Frame: during the surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Aortic anastomosis surgery will be conducted using HDH device.
Device: HDH
sutureless vascular anastomosis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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/
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805831

Locations
Israel
Barzilai Medical center
Ashkelon, Israel, 78278
Sponsors and Collaborators
HDH Medical Ltd
Investigators
Principal Investigator: Boris Yofee, MD Barzilai Medical Center, Ashkelon, Israel
  More Information

No publications provided

Responsible Party: Dr. Hanna Levy, Clinical Study Consultant, Qsite
ClinicalTrials.gov Identifier: NCT00805831     History of Changes
Other Study ID Numbers: HDH -AAA-P-01
Study First Received: December 9, 2008
Last Updated: July 4, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by HDH Medical Ltd:
sutureless vascular bypass

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Vascular Diseases
Arterial Occlusive Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014