Distal Venous Arterialisation of Ischemic Limb

Study Overview
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Brief Summary
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Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible peripheral arterial occlusive disease.

Detailed Description
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The aim of this study was to estimate validity of distal venous arterialisation (DVA) as a limb salvage procedure. This prospective randomized study reported early results of 30 unreconstructible patients with critical limb ischemia (CLI) treated during 2009 year at Clinic for vascular surgery, Clinical Center of Serbia in Belgrade. Patients were divided in two groups, 10 treated with DVA and 20 conservatively (CT) using antiplatelet drugs.

Official Title
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Distal Venous Arterialisation in the Treatment of Critical Ischemia of Lower Limb

Conditions
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Critical Limb Ischemia

Intervention / Treatment
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* Procedure: distal venous arterialisation
* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Absence of any possibility for direct revascularisation due to extensive occlusive disease of crural and pedal arteries Sufficient deep venous system and usable great saphenous vein as a graft for in situ bypass surgery according duplex scanning localized infective of necrotic process up to the metatarsal level Satisfactory general patient condition Exclusion Criteria: advanced lower limb ischemia venous insufficiency of lower limb

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: critical ischemia<br> | Procedure: distal venous arterialisation<br>* The investigators perform reverse revascularisation of the ischemic limb with arterial blood supply from patent in flow artery to the superficial dorsal venous arch.<br>* Other names: Venous arterialisation, arteriovenous reversal;|
| No Intervention: Control<br>Best medical treatment | Drug: Aspirin<br>* 100 mg per day continuous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| limb salvage | The investigators will estimate clinical improvement in patients with critical limb ischemia underwent of distal venous arterialisation. Comparative group consist patients treated with antiplatelet drugs. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lactate level in the blood of deep venous system | The investigators measure metabolic changes in the patients after distal venous arterialisation | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unreconstructable peripheral arterial disease