The Mechanical Characterisation of Human Saphenous and Popliteal Vein

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

Study Overview

• Status: Recruiting
• Conditions: Peripheral Vascular Diseases

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Fiona Leahy, CNM Research; Phone Number: 061588394; Email: fionac.leahy@hse.ie

Study Locations

• Ireland
  • Limerick, Ireland
    • Recruiting
    • University Hospital Limerick
    • Contact: Fiona Leahy, CNM Research; Phone Number: 061588394; Email: fionac.leahy@hse.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Study population will consist of individuals under the care of a Vascular Consultant. Patients will be asked to participate if they are going for a procedure in which there will be vein tissue waste that would usually be discarded in the operating theatre. The procedures of interest are Varicose Vein Procedures, Lower Limb Amputation and Lower Limb Bypass Surgery.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The identification of vein tissue mechanical distension and stretching properties.	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.	2 years

Collaborators and Investigators

• Sponsor: University Hospital of Limerick
• Collaborators: University of Limerick
• Investigators: Principal Investigator: Eamon Kavanagh, MD FRCSI, University Hospital of Limerick

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Estimated): January 21, 2025
• Study Completion (Estimated): March 21, 2025

Study Registration Dates

• First Submitted: July 4, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: DVS004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Vein Tissue will be shared with research collaborators at the Univeristy of Limerick for the purpose of mechanical characterisation.

Patient data will not leave the site of origin. No patient identifiable data will be shared. Vein tissue sample will be labelled with a study number and dated. No patient identifiable data will be labelled on the specimen container.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No