NL-OMON55609
Recruiting
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- claudication
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 110
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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
Outcomes
Primary Outcomes
Not specified
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