Distal Venous Arterialisation of Ischemic Limb

Clinical Centre of Serbia

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Critical Limb Ischemia

Treatments: Drug: Aspirin; Procedure: distal venous arterialisation

Study type: Interventional

Funder types: Other

Identifiers

NCT01211925

440/III-3

Details and patient eligibility

About

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

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

critical ischemia

Experimental group

Treatment:

Procedure: distal venous arterialisation

Control

No Intervention group

Description:

Best medical treatment

Treatment:

Drug: Aspirin