NCT03898869

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

1.8 years

First QC Date

March 29, 2019

Last Update Submit

March 29, 2019

Conditions

Percutaneous Transluminal AngioplastyWound HealIschemic Feet

Outcome Measures

Primary Outcomes (1)

  • Increase in oxygen amount sufficient for wound healing

    12 months

Secondary Outcomes (1)

  • Detection of early recoil after BTK revascularization

    1 hour

Interventions

Intraoperative NIRS monitoringDIAGNOSTIC_TEST

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

Eligibility Criteria

Age55 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All-comers meeting eligibility criteria in VMK hospital, Vascular surgery department.

You may qualify if:

  • Critical limb ischemia Rutherford V-VI
  • At least one artery below the knee is planned to revascularize

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilniaus Miesto Klinikinė hospital

Vilnius, LT-10207, Lithuania

RECRUITING

Study Officials

  • Tomas Baltrūnas

    Vilnius University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomas Baltrūnas

CONTACT

+37052344519tomas.baltrunas@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Tomas Baltrūnas

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 2, 2019

Study Start

March 29, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

April 2, 2019

Record last verified: 2019-03

Locations

LI(1)