Measurement of Revascularization Effect Using NIRS in BTK Arteries

Vilnius University

Status: Unknown

Conditions: Wound Heal; Ischemic Feet; Percutaneous Transluminal Angioplasty

Treatments: Diagnostic Test: Intraoperative NIRS monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT03898869

BTK-01

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 55 to 95 years old

Volunteers: No Healthy Volunteers

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