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

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

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55609

Enrollment

110

Registered

2018-12-12

Start date

2019-02-13

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

claudication peripheral occlusive disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
primairy outcome: Peripheral tissue perfusion of the lower limb expressed in drainage ratio: Drainage ratio = (fluorescence on 5 min after injection/maximum fluorescence) * 100	—

Secondary

Measure	Time frame
none	—

Countries

Netherlands

Outcome results