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Measurement of Revascularization Effect Using NIRS in BTK Arteries

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03898869
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Information provided by (Responsible Party):
Tomas Baltrūnas, 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.

Condition or disease Intervention/treatment
Percutaneous Transluminal Angioplasty Wound Heal Ischemic Feet Diagnostic Test: Intraoperative NIRS monitoring

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Measurement of Revascularization Effect Using Near Infrared Spectroscopy in Below the Knee Arteries
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Intervention Details:
  • Diagnostic Test: Intraoperative NIRS monitoring
    Near infrared spectroscopy non invasively used to register changes in tissue oxygen amount during endovascular revascularization

Primary Outcome Measures :
  1. Increase in oxygen amount sufficient for wound healing [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Detection of early recoil after BTK revascularization [ Time Frame: 1 hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All-comers meeting eligibility criteria in VMK hospital, Vascular surgery department.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03898869

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Contact: Tomas Baltrūnas +37052344519

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Vilniaus Miesto Klinikinė hospital Recruiting
Vilnius, Lithuania, LT-10207
Contact: Tomas Baltrūnas         
Sponsors and Collaborators
Vilnius University
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Principal Investigator: Tomas Baltrūnas Vilnius University
Additional Information:

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Responsible Party: Tomas Baltrūnas, Vilnius University Identifier: NCT03898869    
Other Study ID Numbers: BTK-01
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No