Distal Venous Arterialisation of Ischemic Limb
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
time frame: 1 year
lactate level in the blood of deep venous system
time frame: 1 year
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
|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.|
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