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Experimental Study of the Vascular Prosthesis Manufactured by Electrospinning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255188
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : September 8, 2017
Sponsor:
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation

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.

Condition or disease Intervention/treatment
ARTERIAL OCCLUSIVE DISEASE Procedure: blood sampling procedure

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluate Hemocompatibility Vascular Prosthesis to Prevent Its Thrombosis
Study Start Date : October 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Graft type - PCL
PCL - polycaprolactone
Procedure: blood sampling procedure
30 ml of venous blood will be collected from all voluteers using a special vacuum tubes after informed consent. Blood sampling is carried out from an arm vein. All subsequent studies will be executed in the laboratory diagnostic division of Novosibirsk Research Institute of Circulation Pathology and the presence of the donors is unnecessary

Graft type - PCL/ gelatin
polycaprolactone/ gelatin/poorly permeable layer;
Procedure: blood sampling procedure
30 ml of venous blood will be collected from all voluteers using a special vacuum tubes after informed consent. Blood sampling is carried out from an arm vein. All subsequent studies will be executed in the laboratory diagnostic division of Novosibirsk Research Institute of Circulation Pathology and the presence of the donors is unnecessary

Graft type - PLGA/PCL/gelatin
PLGA/PCL/gelatin - polylactide-co-glycolide / polycaprolactone / gelatin/poorly permeable layer
Procedure: blood sampling procedure
30 ml of venous blood will be collected from all voluteers using a special vacuum tubes after informed consent. Blood sampling is carried out from an arm vein. All subsequent studies will be executed in the laboratory diagnostic division of Novosibirsk Research Institute of Circulation Pathology and the presence of the donors is unnecessary

Graft type - nylon 6 Procedure: blood sampling procedure
30 ml of venous blood will be collected from all voluteers using a special vacuum tubes after informed consent. Blood sampling is carried out from an arm vein. All subsequent studies will be executed in the laboratory diagnostic division of Novosibirsk Research Institute of Circulation Pathology and the presence of the donors is unnecessary




Primary Outcome Measures :
  1. Number of participants (blood samples) having a higher degree of aggregation of platelets after interaction with the prosthesis, as a sign of thrombosis. (with ristomycin, adrenaline, collagen, ADP) [ Time Frame: during the day ]
    percentage


Secondary Outcome Measures :
  1. Platelet count [ Time Frame: during the day ]
    cells / L

  2. Prothrombin time [ Time Frame: during the day ]
    seconds


Other Outcome Measures:
  1. International Normalised Ratio [ Time Frame: during the day ]
  2. activated partial thromboplastin time [ Time Frame: during the day ]
    seconds

  3. prothrombin Quick [ Time Frame: during the day ]
  4. thrombin time [ Time Frame: during the day ]
    seconds

  5. soluble fibrin monomer complexes [ Time Frame: during the day ]
    0-4mg/100ml

  6. free hemoglobin [ Time Frame: during the day ]
    g / l

  7. P- selectin concentrations [ Time Frame: during the day ]
    ng / ml

  8. Adhesion of blood cells on the surface of the prosthesis [ Time Frame: during the day ]
    microscopy



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
volunteers, donors
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255188


Locations
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Russian Federation
popova Irina
Novosibirsk, Novosibirskay obl., Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
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Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT02255188    
Other Study ID Numbers: 16.01.2014 № 2
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: July 2015
Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Haemostas, prosthesis
Additional relevant MeSH terms:
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Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases