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Recruiting NCT04016649

The Mechanical Characterisation of Human Saphenous and Popliteal Vein

Observational Peripheral Vascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Peripheral Vascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ireland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • The identification of vein tissue mechanical distension and stretching properties. [Time frame: 2 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Ireland · 1 center
  • University Hospital Limerick — Limerick

Identifiers

NCT: NCT04016649 · DVS004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗