Near-infrared fluorescence with indocyanine green for intra-procedural assessment of foot perfusion following endovascular revascularization

Near-infrared fluorescence with indocyanine green for intra-procedural assessment of foot perfusion following endovascular revascularization - INFLOW

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56820

Enrollment

Registered

2024-06-12

Start date

2024-08-12

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood flow of lower leg Lower extremity tissue perfusion

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The main outcome parameter is the difference between quantified fluorescence in the foot, before - and after the endovascular intervention.	—

Secondary

Measure	Time frame
- usability score of the technique by vascular surgeon or interventional radiologist - correlation between quantified fluorescence parameters, judged effect by angiography and duplex ultrasound measurement	—

Countries

Netherlands

Outcome results