Status:
COMPLETED
Experimental Study of the Vascular Prosthesis Manufactured by Electrospinning
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
ARTERIAL OCCLUSIVE DISEASE
Eligibility:
All Genders
18-50 years
Brief Summary
The purpose of this study is to determine whether the Vascular prosthesis manufactured by Electrospinning is safe with respect to the development of thrombosis.
Detailed Description
To test the influence of the prostheses to hemostasis blood will be pumped through the vascular prosthesis or control silicone tube (both with identical inner diameter 1,7 mm) during 20 minutes at a l...
Eligibility Criteria
Inclusion
- Male or female aged from 18 to 50 years at the date of the informed consent signing;
- Patients without atherosclerosis
- Patients without blood pathology
Exclusion
- Patient did not sign the informed consent.
- Early postoperative period.
- Concomitant diseases such as atherosclerosis, blood pathology, venous thrombosis, malignancy, terminal cancer, infectious - inflammatory disease at the time of the study.
- Patients after implantation of a cardioverter-defibrillator; prior prosthetic heart valves or other implants, which can lead to mechanical damage to the blood cells.
- Receiving anticoagulants, antiplatelet, antibacterial drugs, NSAIDs.
- Myocardial infarction less than 3 months ago.
- Irreversible failure of major organs with an expected survival time of less than 1 year
- Pregnancy, lactation.
- Age above 50 years.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02255188
Start Date
October 1 2014
End Date
November 1 2015
Last Update
September 8 2017
Active Locations (1)
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1
popova Irina
Novosibirsk, Novosibirskay Obl., Russia, 630055