Measurement of Revascularization Effect Using NIRS in BTK Arteries

• Conditions: Ischemic Feet; Wound Heal; Percutaneous Transluminal Angioplasty

• Registration Number: NCT03898869
• Lead Sponsor: Vilnius University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-03
• Study Start: 2019-03-29
• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-03-29
• Last Update Submitted: 2019-03-29
• Study First Posted: 2019-04-02
• Last Update Posted: 2019-04-02
• Primary Completion: 2021-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in oxygen amount sufficient for wound healing	12 months

Secondary Outcome Measures

Name	Time	Method
Detection of early recoil after BTK revascularization	1 hour

Trial Locations

Locations (1)

Vilniaus Miesto Klinikinė hospital; 🇱🇹 Vilnius, Lithuania