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OpenTrials
Completed

NCT Number: NCT00805831

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.

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Key information

Conditions

Vascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barzilai Medical center

Ashkelon, 78278, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/

Treatment and study plan

HDH

Device

sutureless vascular anastomosis

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.

    Time frame: within 1 month

Secondary outcomes

  1. Time to complete the anastomosis

    Time frame: during the surgery

Sponsors and collaborators

Lead sponsor

HDH Medical Ltd

Industry

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 10, 2008
Registry last updated
Jul 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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