Distal Venous Arterialisation of Ischemic Limb

NCT01211925 | Unknown Phase 2

• 1 other identifier: 440/III-3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Critical Limb Ischemia

Keywords

unreconstructable peripheral arterial disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• lactate level in the blood of deep venous system

  1 year

Study Arms (2)

critical ischemia

EXPERIMENTAL

Procedure: distal venous arterialisation

Control

NO INTERVENTION

Best medical treatment

Drug: Aspirin

Interventions

distal venous arterialisation 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.

Also known as: Venous arterialisation, arteriovenous reversal

critical ischemia

Aspirin DRUG

100 mg per day continuous

Control

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• advanced lower limb ischemia
• venous insufficiency of lower limb

Sponsors & Collaborators

• Clinical Centre of Serbia: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

Clinical Center of Serbia

Belgrade, Serbia, 11000, Serbia

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Predrag Vl Djoric, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 30, 2010
• Study Start: September 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2011
• Last Updated: September 30, 2010

Record last verified: 2010-09

Locations

SE (1)