Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 9:44 PM
Study NCT ID:
NCT03898869
Status:
UNKNOWN
Last Update Posted:
2019-04-02
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Revascularization Effect Using NIRS in BTK Arteries
Sponsor:
Vilnius University
Organization:
Study Overview
Official Title:
Measurement of Revascularization Effect Using Near Infrared Spectroscopy in Below the Knee Arteries
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: