Measurement of Revascularization Effect Using NIRS in BTK Arteries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-29

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Intraoperative NIRS monitoring

Near infrared spectroscopy non invasively used to register changes in tissue oxygen amount during endovascular revascularization

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No