Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
Primary Purpose
Vascular Disease, Atherosclerosis
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
HDH
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Disease focused on measuring sutureless vascular bypass
Eligibility Criteria
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/
Sites / Locations
- Barzilai Medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Aortic anastomosis surgery will be conducted using HDH device.
Outcomes
Primary Outcome Measures
To establish safety of using the HDH device for creating sutureless aortic anastomosis. Safety will be established by lack of serious adverse events.
Secondary Outcome Measures
Time to complete the anastomosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00805831
Brief Title
Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
Official Title
Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
HDH Medical Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Disease, Atherosclerosis
Keywords
sutureless vascular bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Aortic anastomosis surgery will be conducted using HDH device.
Intervention Type
Device
Intervention Name(s)
HDH
Intervention Description
sutureless vascular anastomosis
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Time to complete the anastomosis
Time Frame
during the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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/
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris Yofee, MD
Organizational Affiliation
Barzilai Medical Center, Ashkelon, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barzilai Medical center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
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