Peripheral Artery Disease Clinical Trial
Official title:
Investigation of the Arterial Effects of the Veinoplus(r) Stimlator Device.
Stimulation of arterial inflow to the lower limb is important to obtain functional
improvement in peripheral artery diseased (PAD) patients with claudication. The clinical
effect of muscle stimulation to increase arterial inflow and the direct evaluation of the
regional blood flow impairment (RBFI) in the area of stimulation, have not been evaluated in
PAD patients.
Fifteen adult patients with stable arterial claudication will participate. Recruitment will
be performed among patients referred for exercise oxymetry (treadmill: 3.2km.h-1, 10% slope)
After two minutes of rest, the gastrocnemius will be stimulated for 20 minutes at an
increasing frequency rate with 5 min steps (1 Hz, 1.25 Hz, 1.5 Hz and 1.75 Hz) on the most
symptomatic side.
The investigators record the tcpo2 value, arterial blood inflow with ultrasound of the
femoral artery, and near infra-red spectrometry (NIRS) on both sides.
Patients will be instructed to report eventual contraction-induced pain in the stimulated
calf.
Investigations are conducted in an air-conditioned 22+/-2 °C room, with the patient
comfortably seated on an armchair.
Measured ware started at rest and performed throughout the period pf stimulation and for 10
minutes after the end of the stimulation
Muscle stimulation:
We apply a series of 20 minutes of stimulation with the Veinoplus® device. The device
delivers a stimulation of incremental rate with 5 minutes intervals, with 1 Hz, 1.25 Hz, 1.5
Hz and 1.75 Hz and then stops automatically.
Ultrasound measurements The Diameter of the superficial femoral artery was measured at rest
on both sides before each study. The VTI of 3 cardiac cycles (three peaks systolic velocity)
will be measured by duplex ultrasound imaging, to calculate the arterial inflow to the leg.
Results will be expressed in l /min.
Tcpo2 recording TcpO2 is measured at the chest and on both calves with TCM 400 (Radiometer,
DK). Results are expressed in DROP index(mmHg) values.
Near Infra-red spectroscopy (NIRS) We use the ARTinis NIRS device (ARTinis; NL) to estimate
tissue saturation (StO2) on both gastrocnemius muscles of the leg.
Systemic hemodynamic parameters
Systemic and diastolic arterial pressures and heart rate are recorded every two minutes
using Dinamap V100 (GE france).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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