Distal Venous Arterialisation of Ischemic Limb | NCT01211925

Studies
Distal Venous Arterialisation of Ischemic Limb

NCT01211925

Sponsor

Clinical Centre of Serbia

Status

Unknown status

Last Update Posted

Sep 30, 2010Estimated

Enrollment

30Actual

Phase

Phase 2Phase 3

Conditions

Critical Limb Ischemia

Interventions

distal venous arterialisation
Aspirin

Countries

Serbia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2011Estimated

First Submitted Date

Sep 16, 2010

First Submission Date that Met QC Criteria

Sep 29, 2010

First Posted Date

Sep 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2010

Last Update Posted Date

Sep 30, 2010Estimated

Name	Class
University of California, Los Angeles	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
critical ischemia	Experimental		Procedure: distal venous arterialisation
Control	No Intervention	Best medical treatment	Drug: Aspirin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
lactate level in the blood of deep venous system	The investigators measure metabolic changes in the patients after distal venous arterialisation	1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Predrag Vl Djoric, MD	Clinical Center of Serbia in Belgrade, Clinic for Vascular and Endovascular Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Center of Serbia		Belgrade	Serbia	11000	Serbia

Condition Browse Module

MeSH Terms

ID	Term
D000089802	Chronic Limb-Threatening Ischemia

Ancestor Terms

ID	Term
D058729	Peripheral Arterial Disease
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001241	Aspirin

Ancestor Terms

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided