- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03898869
Measurement of Revascularization Effect Using NIRS in BTK Arteries
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
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Tomas Baltrūnas
- Phone Number: +37052344519
- Email: tomas.baltrunas@gmail.com
Study Locations
-
-
-
Vilnius, Lithuania, LT-10207
- Recruiting
- Vilniaus Miesto Klinikinė hospital
-
Contact:
- Tomas Baltrūnas
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Sponsor
Investigators
- Principal Investigator: Tomas Baltrūnas, Vilnius University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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