Measurement of Revascularization Effect Using NIRS in BTK Arteries

March 29, 2019 updated by: Tomas Baltrūnas, Vilnius University

Measurement of Revascularization Effect Using Near Infrared Spectroscopy in Below the Knee Arteries

Patient with occluded below the knee arteries and chronic limb ischemia Rutherford class V-VI are enrolled.

During endovascular recanalisation procedure changes in tissue oxygen amount is recorded using near infrared spectroscopy (NIRS).

Primary hypothesis - NIRS can be used to determine sufficient amount of blood reaching the ulcered ishemic area.

Secondary hypothesis - NIRS can be useful in detecting early recoil after BTK recanalisation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lithuania
      • Vilnius, Lithuania, LT-10207
        • Recruiting
        • Vilniaus Miesto Klinikinė hospital
        • Contact:
          • Tomas Baltrūnas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All-comers meeting eligibility criteria in VMK hospital, Vascular surgery department.

Description

Inclusion Criteria:

  • Critical limb ischemia Rutherford V-VI
  • At least one artery below the knee is planned to revascularize

Exclusion Criteria:

  • Blood oxygen saturation below 85% because of any comorbidities
  • Life expectancy less than 12 months
  • Unavoidable amputation above ankle
  • Skin diseases preventing the use of NIRS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increase in oxygen amount sufficient for wound healing
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Detection of early recoil after BTK revascularization
Time Frame: 1 hour
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vilnius University

Investigators

  • Principal Investigator: Tomas Baltrūnas, Vilnius University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

March 29, 2019

First Submitted That Met QC Criteria

March 29, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 29, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • BTK-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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