ear-infrared fluorescence with indocyanine green for intra-procedural assessment of foot perfusion following endovascular revascularizatio

Recruiting

• Conditions: blood flow of lower leg; Lower extremity tissue perfusion; 10003184; 10003216

• Registration Number: NL-OMON56820
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Adult (>18 years).
2. Rest pain or wounds due to LEAD
3. Scheduled for lower extremity endovascular revascularization.
4. Able to understand the information and implication of participation in the
study.

Exclusion Criteria

1. Allergy to ICG, iodine or sodium iodide.
2. Allergy to shellfish.
3. Hyperthyroidism.
4. Autonomous thyroid adenoma.
5. Previous hypersensitivity to ICG.
6. Pregnancy or breastfeeding.
7 Kidney failure (eGFR <10 ml/min/1.73m2).
8. Any condition that the investigator considers to be potentially jeopardizing
the patient*s well-being or the study objectives.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main outcome parameter is the difference between quantified fluorescence in<br /><br>the foot, before - and after the endovascular intervention.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- usability score of the technique by vascular surgeon or interventional<br /><br>radiologist<br /><br>- correlation between quantified fluorescence parameters, judged effect by<br /><br>angiography and duplex ultrasound measurement</p><br>