This trial is active, not recruiting.

Condition critical limb ischemia
Treatments distal venous arterialisation, aspirin
Phase phase 2/phase 3
Sponsor Clinical Centre of Serbia
Collaborator University of California, Los Angeles
Start date September 2009
End date July 2010
Trial size 30 participants
Trial identifier NCT01211925, 440/III-3


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
distal venous arterialisation Venous arterialisation, arteriovenous reversal
The investigators perform reverse revascularisation of the ischemic limb with arterial blood supply from patent in flow artery to the superficial dorsal venous arch.
(No Intervention)
Best medical treatment
100 mg per day continuous

Primary Outcomes

limb salvage
time frame: 1 year

Secondary Outcomes

lactate level in the blood of deep venous system
time frame: 1 year

Eligibility Criteria

Male or female participants from 20 years up to 95 years old.

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

Additional Information

Official title Distal Venous Arterialisation in the Treatment of Critical Ischemia of Lower Limb
Principal investigator Predrag Vl Djoric, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by Clinical Centre of Serbia.