Safety and Efficacy of Using HDH Device and Method - a Novel Sutureless Vascular Anastomosis
NCT ID: NCT00805831
Last Updated: 2010-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2008-10-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
Aortic anastomosis surgery will be conducted using HDH device.
HDH
sutureless vascular anastomosis
Interventions
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HDH
sutureless vascular anastomosis
Eligibility Criteria
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Inclusion Criteria
* 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'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/
18 Years
ALL
No
Sponsors
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HDH Medical Ltd
INDUSTRY
Responsible Party
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Qsite
Principal Investigators
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Boris Yofee, MD
Role: PRINCIPAL_INVESTIGATOR
Barzilai Medical Center, Ashkelon, Israel
Locations
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Barzilai Medical center
Ashkelon, , Israel
Countries
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Other Identifiers
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HDH -AAA-P-01
Identifier Type: -
Identifier Source: org_study_id
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