Measurement of Revascularization Effect Using NIRS in BTK... | NCT03898869

Studies
Measurement of Revascularization Effect Using NIRS in BTK Arteries

NCT03898869

Sponsor

Vilnius University

Status

Unknown status

Last Update Posted

Apr 2, 2019Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Percutaneous Transluminal Angioplasty
Wound Heal
Ischemic Feet

Interventions

Intraoperative NIRS monitoring

Countries

Lithuania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2019Actual

Primary Completion Date

Jan 2021Estimated

Completion Date

Jan 2022Estimated

First Submitted Date

Mar 29, 2019

First Submission Date that Met QC Criteria

Mar 29, 2019

First Posted Date

Apr 2, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2019

Last Update Posted Date

Apr 2, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraoperative NIRS monitoring	Diagnostic Test	Near infrared spectroscopy non invasively used to register changes in tissue oxygen amount during endovascular revascularization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Increase in oxygen amount sufficient for wound healing		12 months

Secondary Outcomes

Measure	Description	Time Frame
Detection of early recoil after BTK revascularization		1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tomas Baltrūnas	Contact	+37052344519		tomas.baltrunas@gmail.com

Overall Officials

Name	Affiliation	Role
Tomas Baltrūnas	Vilnius University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vilniaus Miesto Klinikinė hospital	Recruiting	Vilnius		LT-10207	Lithuania