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

NCT00805831 | Completed

• 1 other identifier: HDH -AAA-P-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Disease; Atherosclerosis

Keywords

sutureless vascular bypass

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to complete the anastomosis

  during the surgery

Study Arms (1)

A

EXPERIMENTAL

Aortic anastomosis surgery will be conducted using HDH device.

Device: HDH

Interventions

HDH DEVICE

sutureless vascular anastomosis

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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/

Sponsors & Collaborators

• HDH Medical Ltd: lead

Study Sites (1)

Barzilai Medical center

Ashkelon, 78278, Israel

Location

MeSH Terms

Conditions

Vascular Diseases; Atherosclerosis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Boris Yofee, MD

  Barzilai Medical Center, Ashkelon, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 9, 2008
• First Posted: December 10, 2008
• Study Start: October 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 7, 2010

Record last verified: 2010-07

Locations

IL (1)