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

VascuActive

Status: Completed

Conditions: Peripheral Vascular Diseases

Treatments: Device: VascuActive

Study type: Interventional

Funder types: Industry

Identifiers

NCT01014377

VAS-01

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)