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Distal Venous Arterialisation of Ischemic Limb

NCT ID: NCT01211925

Last Updated: 2010-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Critical Limb Ischemia

Keywords

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unreconstructable peripheral arterial disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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critical ischemia

Group Type EXPERIMENTAL

distal venous arterialisation

Intervention Type PROCEDURE

The investigators perform reverse revascularisation of the ischemic limb with arterial blood supply from patent in flow artery to the superficial dorsal venous arch.

Control

Best medical treatment

Group Type NO_INTERVENTION

Aspirin

Intervention Type DRUG

100 mg per day continuous

Interventions

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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.

Intervention Type PROCEDURE

Aspirin

100 mg per day continuous

Intervention Type DRUG

Other Intervention Names

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Venous arterialisation, arteriovenous reversal

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

Clinical Centre of Serbia

OTHER

Sponsor Role lead

Responsible Party

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Clinical Center of Serbia, Belgrade

Principal Investigators

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Predrag Vl Djoric, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Center of Serbia in Belgrade, Clinic for Vascular and Endovascular Surgery

Locations

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Clinical Center of Serbia

Belgrade, Serbia, Serbia

Site Status

Countries

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Serbia

Other Identifiers

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440/III-3

Identifier Type: -

Identifier Source: org_study_id