Effect of VascuActive Device on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With PVD & Limb Ischemia

Assessment of the Safety of the VascuActive™ Device and Its Preliminary Efficacy on Foot Perfusion, Hemodynamics and Exercise Capacity in Patients With Peripheral Vascular Disease and Limb Ischemia

The purpose of this study is to assess the safety and the immediate effect of the VascuActive device on patients with peripheral vascular disease and limb ischemia.

Inclusion Criteria:

• Leg Ischemia, Fontaine grade IIa and IIb, i.e.: pain free walking distance in the range of 50 - 100 meters.
• Absent pulses in the two foot arteries (Anterior Tibial a., Posterior Tibial a.)
• ABI < 0.7 by Doppler, in at least one of the two foot arteries

Exclusion Criteria:

• Absent femoral pulses
• Venous insufficiency by Duplex
• Pregnancy
• Infectious disease
• Malignant disease
• Severe cardiac disease, e.g., CHF grade 3 or higher
• Acute MI within last 3 months
• CABG within last 3 months
• Other severe systemic disease