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Clinical Trials/NCT04016649
NCT04016649
Recruiting
Not Applicable

The Mechanical Characterisation of Human Saphenous and Popliteal Vein

University Hospital of Limerick1 site in 1 country50 target enrollmentJanuary 21, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Vascular Diseases
Sponsor
University Hospital of Limerick
Enrollment
50
Locations
1
Primary Endpoint
The identification of vein tissue mechanical distension and stretching properties.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Non-interventional study aiming to ascertain the mechanical properties of human saphenous and popliteal vein tissue.

Detailed Description

The aim of this study is to mechanically characterise saphenous and popliteal vein segments that have been deemed waste following varicose vein procedures, lower limb amputation and lower limb bypass surgery. By characterising the stress-stretch relationship of the vein vessel wall, treatment techniques can be better understood. Mechanical device design can be bteer informed and the the suitability of vein as a conduit for bypass and AVF procedures can be assessed.

Registry
clinicaltrials.gov
Start Date
January 21, 2019
End Date
March 21, 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital of Limerick
Responsible Party
Principal Investigator
Principal Investigator

Fiona Leahy

Professor Eamon Kavanagh Prinicipal Investigator

University Hospital of Limerick

Eligibility Criteria

Inclusion Criteria

  • Male or Female patients aged 18 years or older
  • Patients undergoing varicose vein procedures or;
  • Patients undergoing lower limb amputation or;
  • Patients undergoing lower limb bypass surgery

Exclusion Criteria

  • Patients unable to give informed consent
  • Seriously ill/unconscious patients

Outcomes

Primary Outcomes

The identification of vein tissue mechanical distension and stretching properties.

Time Frame: 2 years

Vein tissue will undergo inflation-extension testing and unilaxial testing. The vein tissue will be cross-sectioned and rings of venous tissue will be mechanically characterised according to the properties exhibited.

Study Sites (1)

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