Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-21 @ 9:03 AM
Study NCT ID:
NCT02337920
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2014-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal
Sponsor:
University Hospital, Caen
Organization:
Study Overview
Official Title:
Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
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:
TEA-NIRS
Brief Summary:
Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need complementary stenting of revascularization procedures within the 2 years after the primary surgery because of a poor blood supply in their lower limb extremity. The Near infrared spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and provide information on the quality of the local oxygen supply. The aim of our observational study is to correlate the intraoperative NIRS variations at the calf and the soles and the one-year evolution of the arteritis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: