Measurement of Revascularization Effect Using NIRS in BTK Arteries

Vilnius University30 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Percutaneous Transluminal Angioplasty Wound Heal Ischemic Feet

Interventions

Intraoperative NIRS monitoringDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 55 YearsMax age: 95 Years

Medical Language ↔ Plain English

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

Locations (1)

Vilniaus Miesto Klinikinė hospital

Vilnius, Lithuania

RECRUITING

Outcomes

Primary Outcomes

Increase in oxygen amount sufficient for wound healing

Time frame: 12 months

Secondary Outcomes

Detection of early recoil after BTK revascularization

Time frame: 1 hour

Central Contacts

Tomas Baltrūnas

CONTACT

+37052344519 tomas.baltrunas@gmail.com

Data from ClinicalTrials.gov

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