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

HDH Medical

Status: Completed

Conditions: Vascular Disease; Atherosclerosis

Treatments: Device: HDH

Study type: Interventional

Funder types: Industry

Identifiers

NCT00805831

HDH -AAA-P-01

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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/

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

A

Experimental group

Description:

Aortic anastomosis surgery will be conducted using HDH device.

Treatment:

Device: HDH