Anatomical mapping and assessment of tissue perfusion using indocyanine green near-infrared fluorescence in patients with peripheral arterial disease.

Phase 2

Recruiting

• Conditions: claudication; peripheral occlusive disease; 10003184; 10003216

• Registration Number: NL-OMON55609
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

- 18 years or older
- patients with peripheral vascular disease catagorized wit at least fontaine
2A classification
- Abscence of any psychological, familial, sociological or geographical
condition potentially hampering
compliance with the study protocol and follow-up schedule; those conditions
should be discussed with the patient before registration in the trial.
- Before patient registration, written consent must be given according to
ICH/GCP, national and local
regulations.

Exclusion Criteria

- hisory of allergy to iodine, shellfish or ICG
- patients with hyperthyroidism
- pregnant or lactating woman
- any condition that in the opinion of the investigator could potentially
jeopardize the health status of the patient.
- patients with severe liver failure

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>primairy outcome:<br /><br>Peripheral tissue perfusion of the lower limb expressed in drainage ratio:<br /><br>Drainage ratio = (fluorescence on 5 min after injection/maximum fluorescence) *<br /><br>100</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>none</p><br>