Measurement of Revascularization Effect Using NIRS in BTK Arteries
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|ClinicalTrials.gov Identifier: NCT03898869|
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
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|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||30 participants|
|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|
- Diagnostic Test: Intraoperative NIRS monitoring
Near infrared spectroscopy non invasively used to register changes in tissue oxygen amount during endovascular revascularization
- Increase in oxygen amount sufficient for wound healing [ Time Frame: 12 months ]
- Detection of early recoil after BTK revascularization [ Time Frame: 1 hour ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898869
|Contact: Tomas Baltrūnasemail@example.com|
|Vilniaus Miesto Klinikinė hospital||Recruiting|
|Vilnius, Lithuania, LT-10207|
|Contact: Tomas Baltrūnas|
|Principal Investigator:||Tomas Baltrūnas||Vilnius University|