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Distal Venous Arterialisation of Ischemic Limb

Primary Purpose

Critical Limb Ischemia

Status
Unknown status
Phase
Phase 2
Locations
Serbia
Study Type
Interventional
Intervention
distal venous arterialisation
Aspirin
Sponsored by
Clinical Centre of Serbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Limb Ischemia focused on measuring unreconstructable peripheral arterial disease

Eligibility Criteria

20 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Clinical Center of Serbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

critical ischemia

Control

Arm Description

Best medical treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

lactate level in the blood of deep venous system
The investigators measure metabolic changes in the patients after distal venous arterialisation

Full Information

First Posted
September 16, 2010
Last Updated
September 29, 2010
Sponsor
Clinical Centre of Serbia
Collaborators
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01211925
Brief Title
Distal Venous Arterialisation of Ischemic Limb
Official Title
Distal Venous Arterialisation in the Treatment of Critical Ischemia of Lower Limb
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Clinical Centre of Serbia
Collaborators
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Limb Ischemia
Keywords
unreconstructable peripheral arterial disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
critical ischemia
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Best medical treatment
Intervention Type
Procedure
Intervention Name(s)
distal venous arterialisation
Other Intervention Name(s)
Venous arterialisation, arteriovenous reversal
Intervention Description
The investigators perform reverse revascularisation of the ischemic limb with arterial blood supply from patent in flow artery to the superficial dorsal venous arch.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
100 mg per day continuous
Primary Outcome Measure Information:
Title
limb salvage
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
lactate level in the blood of deep venous system
Description
The investigators measure metabolic changes in the patients after distal venous arterialisation
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Predrag Vl Djoric, MD
Organizational Affiliation
Clinical Center of Serbia in Belgrade, Clinic for Vascular and Endovascular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

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Distal Venous Arterialisation of Ischemic Limb

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