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NCT03898869 Clinical Trial

Measurement of Revascularization Effect Using NIRS in BTK Arteries

Wound Heal Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03898869
Other study ID # BTK-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 29, 2019
Est. completion date January 2022

Study information
Verified date March 2019
Source Vilnius University
Contact Tomas Baltrunas
Phone +37052344519
Email tomas.baltrunas@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date January 2022
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 55 Years to 95 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Intraoperative NIRS monitoring
Near infrared spectroscopy non invasively used to register changes in tissue oxygen amount during endovascular revascularization

Locations
Country Name City State
Lithuania Vilniaus Miesto Klinikine hospital Vilnius

Sponsors (1)
Lead Sponsor Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Increase in oxygen amount sufficient for wound healing 12 months
Secondary Detection of early recoil after BTK revascularization 1 hour
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