Distal Venous Arterialisation of Ischemic Limb

Critical Limb Ischemia Clinical Trial

Official title:

Distal Venous Arterialisation in the Treatment of Critical Ischemia of Lower Limb

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01211925
• Other study ID #: 440/III-3
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: September 16, 2010
• Last updated: September 29, 2010
• Start date: September 2009
• Est. completion date: July 2011

Study information

• Verified date: September 2010
• Source: Clinical Centre of Serbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia

Intervention

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.

Drug:
• Aspirin
100 mg per day continuous

Locations

Country	Name	City	State
Serbia	Clinical Center of Serbia	Belgrade

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Centre of Serbia	University of California, Los Angeles

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	Yes
Secondary	lactate level in the blood of deep venous system	The investigators measure metabolic changes in the patients after distal venous arterialisation	1 year	Yes