Use of Indocyanine Green Angiography in Critical Limb Ischemia (FLUORESCENCE)

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Unknown; Phase 3

Conditions: Peripheral Arterial Disease

Treatments: Device: fluorescence angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT02820467

38RC15.212

Details and patient eligibility

About

Investigators conduct a monocentric pilot study with the objective to determine the hemodynamic parameter of fluorescence angiography (slope, amplitude, saturation time ) best correlated with toe pressure in patients with suspicion of critical limb ischemia.

Full description

Critical limb ischemia, defined as the presence of chronic ischemic rest pain, ulcers or gangrene attributable to objectively proven arterial occlusive disease, is associated with the appalling prospect that approximately 30% will lose their leg and 25% will die at one year. Despite the progress of therapeutics these statistics haven't changed. Critical limb ischemia is a clinical diagnosis but should be supported by objective tests. None of theses tests (toe blood pressure (TBP), transcutaneous oxygen pressure (TcPO2) and skin perfusion pressure (SPP)) have proven to be enough specific or sensitive, more so they are time consuming, can be subject to several artifacts and may be in some cases discordant making diagnosis difficult. Fluorescence angiography has long been used in ophthalmology for the evaluation of the microcirculation of the retina. Infracyanine remains within the intravascular space allowing the visualization of the vasculature to a depth of 10 mm. With the Fluobeam system, images to a maximal width of 20 cm can be obtained therefore allowing the evaluation of the tissue perfusion of the entire foot.

Method: Fluorescence angiography is performed in the laboratory in the same time as TCPO2, TP and SPP. Infracyanine is injected in an antecubital vein and visualization and signal acquisition carried out using a specific camera device (Fluoptic SAS, France) producing the time course of hemodynamic parameters (slope, amplitude, saturation time).

30patients will be evaluated with correlation between data obtained by fluorescence angiography and too blood pressure

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with peripheral artery disease and suspicion of critical limb ischemia

Exclusion criteria

• pregnant women

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

patients with suspicion of CLI

Experimental group

Description:

patients presenting with peripheral artery disease and suspicion of critical limb ischemia as assessed by TASK II consensus 30 patients will be enrolled and will benefit of measures of TcPO2, too systolic blood pressure and skin perfusion pressure and in the same time angiography with fluorescence (Indocyanine grey 0.05 mg/kg by intravenous injection

Treatment:

Device: fluorescence angiography