Critical Limb IschemiaPhase 2/3NCT01211925
Distal Venous Arterialisation of Ischemic Limb
A Phase 2/3 study testing distal venous arterialisation and Aspirin in people with Critical Limb Ischemia, run by Clinical Centre of Serbia at 1 site in Serbia.
Trial summary
Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible peripheral arterial occlusive disease. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- distal venous arterialisation and Aspirin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSerbia
- Study dates
- Sep 2009to Jul 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- advanced lower limb ischemia
- venous insufficiency of lower limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distal Venous Arterialisation in the Treatment of Critical Ischemia of Lower Limb
Distal venous arterialisation (DVA) improve outcome in patients with nonreconstructible peripheral arterial occlusive disease.
Read the 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.
- Conditions
- Critical Limb Ischemia
- Being tested
- distal venous arterialisation, Aspirin
- Keywords
- unreconstructable peripheral arterial disease
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distal venous arterialisationProcedure or surgery
Also called Venous arterialisation, arteriovenous reversal
The investigators perform reverse revascularisation of the ischemic limb with arterial blood supply from patent in flow artery to the superficial dorsal venous arch.
AspirinDrug
100 mg per day continuous
| Study group | Role | What they receive |
|---|---|---|
| critical ischemia | Experimental | Not described Receives: Procedure: distal venous arterialisation |
| Control | No intervention | Best medical treatment Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
lactate level in the blood of deep venous system
The investigators measure metabolic changes in the patients after distal venous arterialisation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startSep 2009
- Primary completionJul 2010
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Centre of Serbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Investigators
- Predrag Vl Djoric, MD, Principal investigator, Clinical Center of Serbia in Belgrade, Clinic for Vascular and Endovascular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211925
- Sponsor's protocol ID
- 440/III-3
- Status last verified
- Sep 2010
- First submitted
- 16 Sep 2010
- Last updated
- 30 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Venous Arterialisation in the Treatment of Critical Ischemia of Lower Limb
- ClinicalTrials.gov ID
- NCT01211925
- Acronym / sponsor ID
- 440/III-3
- Conditions
- Critical Limb Ischemia
- Keywords
- unreconstructable peripheral arterial disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Clinical Centre of SerbiaUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| critical ischemia | Experimental | Procedure: distal venous arterialisation |
| Control | No intervention | Drug: AspirinBest medical treatment |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- advanced lower limb ischemia
- venous insufficiency of lower limb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| distal venous arterialisationAlso: Venous arterialisation, arteriovenous reversalThe investigators perform reverse revascularisation of the ischemic limb with arterial blood supply from patent in flow artery to the superficial dorsal venous arch. | Procedure or surgery | critical ischemia |
| Aspirin100 mg per day continuous | Drug | Control |
Primary outcome
limb salvage
Time frame: 1 year
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 secondary outcome
lactate level in the blood of deep venous system
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2010.
Related trials for Critical Limb Ischemia
RecruitingObservational study
miRNAs in Critical Limb Ischemia (miRNACLI)
Critical Limb Ischemia
Active, not recruitingObservational study
Laser Atherectomy and Sirolimus-eluting Balloon Angioplasty for CLTI
Chronic Limb Threatening Ischemia
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Predrag Vl Djoric, MD principal investigator
Clinical Center of Serbia in Belgrade, Clinic for Vascular and Endovascular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing distal venous arterialisation and Aspirin in people with Critical Limb Ischemia, run by Clinical Centre of Serbia at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
limb salvage (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2010.