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Clinical Trials/NCT03898869
NCT03898869
Unknown
Not Applicable

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

Vilnius University1 site in 1 country30 target enrollmentMarch 29, 2019
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ConditionsPercutaneous Transluminal AngioplastyWound HealIschemic Feet

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Percutaneous Transluminal Angioplasty
Sponsor
Vilnius University
Enrollment
30
Locations
1
Primary Endpoint
Increase in oxygen amount sufficient for wound healing
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 29, 2019
End Date
January 2022
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tomas Baltrūnas

Tomas Baltrūnas

Vilnius University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Increase in oxygen amount sufficient for wound healing

Time Frame: 12 months

Secondary Outcomes

  • Detection of early recoil after BTK revascularization(1 hour)

Study Sites (1)

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