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

Peripheral arterial disease (PAD) is a common and potential life-threatening
disease, mainly caused by atherosclerotic
disease.ln case of severe PAD, revascularization therapy is frequently
necessary and can even lead to amputation in
some cases. Present-day conventional diagnostics might give an estimate of
macrovascular deviations but is not
accurate enough to asses tissue perfusion in the end-organ. In some patient
populations conventional diagnostics can
be fasely elevated or can not be measured when previous amputation is
performed. Therefore a dynamic, accurate
and non-invasive diagnostics modality for the assesment of tissueperfusion is
necessary. Indocyanine green NIRF is
considerd a potentional modality for accurate tissueperfusíon imaging used for
PAD diagnostics and in the prediction of
patency after revascularization and potential woundhealing.

The main objective of this study is to asses the applicability and validity of
ICG parameters in the diagnostic work-up in patients with peripheral arterial
disease. We will also asses the applicability of ICG-NIRF in intra-operative
assessment of the level of amputation.

A phase II single centre study. Patients will be divided into 4 groups
(including one controlgroup with healthy
participants).All patients will receive a dosis of ICG based upon weight (0.10
mg/kg) before NIRF measurements.
in the first and second group NIRF imaging will be done both before and after
non-/invasive therapy. In the amputation
group NIRF imaging will be done before, during and 3 days after amputation. The
control group wil undergo NIRF
imaging once. This group will not receive an extra dosis of ICG. We will only
place the fluorescence camera above the feet during or right before the
operation for which they will already receive a dosis of ICG.

Burden:
- On the day of NIRF imaging ICG (0.10 mg/kg) will be administered
intravenously.
- therefor an iv must be placed before every ICG-NIRF measurement (minimum of 1
till maximum of 3 times over a period of 6-7 months).
- NIRF imaging takes about 30 minutes in total. the patient must lay or be
positioned in a semi-seating position for a maximum of 15 minutes).

No additional visits tot the outpatient clinic are necessary.
After the NIRF-measurements are finished the patient can leave the hospital.

Risks:
The risk is estimated as a mediocre risk, this is due to the fact that a body
foreign solution is administered. There is extensive knowledge and experience
with the administration and use of ICG and NIRF within LUMC hospital.
ICG administration has a very low risk of adverse events wherefore treatment is
necessary (0.05-0.07%).