Peripheral arterial occlusive disease
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients: - Written informed consent - Rutherford class 4-6 - Occlusion at the level of the iliac or femoral arteries - Unilateral disease. Control leg must have an ABI >= 0.8, no rest pain, and no ulcers
Exclusion criteria
Exclusion criteria: - Insufficient knowledge of the Dutch language, illiteracy, or language barrier. - Lower leg fracture within the past 12 months. - (Partial) amputation of one of the feet and/or legs. - Known hypersensitivity to indocyanine green or to sodium iodide. - Hyper-thyroidism and autonomic thyroid adenomas. - Renal insufficiency. - Concomitant use of the following: anticonvulsants, bisulphite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphium, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, cyclopropane, probenecid, and rifamycin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success of skin perfusion measurements of lower limb tissue with continuous ICG-VA in PAOD patients (Rutherford class 4-6). Success is defined as the ability to detect hypo perfusion in the diseased leg in comparison with the patient's contralateral control leg with continuous ICG-VA in at least half the patients with good signal quality and sufficient sound to noise ratio. Good signal quality defined as: anatomy of interest identifiable and centred in the camera's field of view; no interference from natural lights (e.g. daylight); no rapid movements of camera relative to anatomy of interest; no change in distance from camera to anatomy of interest. Good SNR defined as: change in fluorescent (ICG) intensity following each ICG bolus is larger than 5x the noise level at baseline (before any ICG is injected). | — |
Secondary
| Measure | Time frame |
|---|---|
| - To develop a standardized measurement protocol for continuous ICG-VA measurements, the dose and injection rate will be determined based on: good signal quality, sufficient sound to noise ratio, and no presence of saturation in the QUEST camera (Quest Medical Imaging BV, Middenmeer, The Netherlands). Good signal quality defined as: anatomy of interest identifiable and centred in the camera's field of view; no interference from natural lights (e.g., daylight); no rapid movements of camera relative to anatomy of interest; no change in distance from camera to anatomy of interest. Good SNR defined as: change in fluorescent (ICG) intensity following each ICG bolus is larger than 5x the noise level at baseline (before any ICG is injected). - To investigate the ability of continuous ICG-VA to detect reperfusion after endovascular revascularisation, the Bland-Altman method will be used to analyze the agreement between the continuous ICG-VA measurements and TcPO2 and ABI tests before and after the procedure. - To test the agreement between continuous ICG-VA and toe pressure measurements before the procedure using the Bland-Altman method | — |
Countries
Netherlands
Outcome results
None listed