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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00805831

Enrollment

Registered

2008-12-10

Start date

2008-10-31

Completion date

2010-06-30

Last updated

2010-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Vascular Disease

Keywords

sutureless vascular bypass

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.

Interventions

DEVICEHDH

sutureless vascular anastomosis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Time to complete the anastomosis	during the surgery

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026