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Distal Venous Arterialisation of Ischemic Limb

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01211925
Recruitment Status : Unknown
Verified September 2010 by Clinical Centre of Serbia.
Recruitment status was:  Active, not recruiting
First Posted : September 30, 2010
Last Update Posted : September 30, 2010
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
Clinical Centre of Serbia

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

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Procedure: distal venous arterialisation Drug: Aspirin Phase 2 Phase 3

Detailed 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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Distal Venous Arterialisation in the Treatment of Critical Ischemia of Lower Limb
Study Start Date : September 2009
Actual Primary Completion Date : July 2010
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: critical ischemia Procedure: distal venous arterialisation
The investigators perform reverse revascularisation of the ischemic limb with arterial blood supply from patent in flow artery to the superficial dorsal venous arch.
Other Name: Venous arterialisation, arteriovenous reversal

No Intervention: Control
Best medical treatment
Drug: Aspirin
100 mg per day continuous




Primary Outcome Measures :
  1. limb salvage [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. lactate level in the blood of deep venous system [ Time Frame: 1 year ]
    The investigators measure metabolic changes in the patients after distal venous arterialisation



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211925


Locations
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Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Sponsors and Collaborators
Clinical Centre of Serbia
University of California, Los Angeles
Investigators
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Principal Investigator: Predrag Vl Djoric, MD Clinical Center of Serbia in Belgrade, Clinic for Vascular and Endovascular Surgery

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Responsible Party: Clinic for Vascular and Endovascular Surgery, Clinical Center of Serbia, Belgrade
ClinicalTrials.gov Identifier: NCT01211925    
Other Study ID Numbers: 440/III-3
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: September 30, 2010
Last Verified: September 2010
Keywords provided by Clinical Centre of Serbia:
unreconstructable peripheral arterial disease
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics