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

NCT ID: NCT01014377

Last Updated: 2010-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Vascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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VascuActive

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VascuActive LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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VascuActive LTD

Locations

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Asaf Harofe Medical Center

Zrifin, , Israel

Site Status

Countries

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Israel

Other Identifiers

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VAS-01

Identifier Type: -

Identifier Source: org_study_id

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