Sutureless Vascular Anastomosis Using HDH Device and Method: Comparison With Sutured Anastomosis - Full Text View

Sponsored by:	HDH Medical Ltd
Information provided by:	HDH Medical Ltd
ClinicalTrials.gov Identifier:	NCT00805831

Purpose

The HDH device is intended for creating sutureless vascular bypass 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 vascular bypass.

Condition	Intervention
Vascular Disease Atherosclerosis	Device: HDH

MedlinePlus related topics: Vascular Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Sutureless Vascular Anastomosis Using HDH Device and Method: Comparison With Sutured Anastomosis

Further study details as provided by HDH Medical Ltd:

Primary Outcome Measures:

To establish safety of using the HDH device for creating sutureless aortic bypass. 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:	30
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Aortic bypass surgery will be conducted using HDH device.	Device: HDH sutureless vascular bypass

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
The size of the aneurysm is larger than 4cm/ its annual growth is larger than 0.5cm/or the size of iliac aneurysm 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 12 months
Patient objects to the treatment or study protocol.
Anesthesiologist or personal care physician object

Contacts and Locations

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

Contacts

Contact: Hanna Levy, Dr.

(972)-4-638-8837

hanna@qsitemed.com

Locations

Israel
Barzilai Medical center	Recruiting
Ashkelon, Israel, 78278
Contact: Hanna Levy, Dr. (972)-4-638-8837 hanna@qsitemed.com
Principal Investigator: Boris Yofee, MD

Sponsors and Collaborators

HDH Medical Ltd

Investigators

Principal Investigator:

Boris Yofee, MD

Barzilai Medical Center, Ashkelon, Israel

More Information

Responsible Party:	Qsite ( Dr. Hanna Levy, Clinical Study Consultant )
Study ID Numbers:	HDH -AAA-P-01
Study First Received:	December 9, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00805831
Health Authority:	Israel: Ministry of Health

Keywords provided by HDH Medical Ltd:

sutureless vascular bypass

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Arteriosclerosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009