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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|