Critical Limb IschemiaNCT04760119
Drug-Eluting Balloon Angioplasty Versus Bypass Surgery as First-Line Strategies in Infrageniculate Arterial Disease for Critical Limb Ischemia in Type 2 Diabetic Pacients: a Randomised Controlled Clinical Trial
A study testing Vein bypass surgery first strategy and Endovascular treatment first (drug coated balloon angioplasty) strategy in people with Critical Limb Ischemia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The aim of this study is to evaluate the outcomes of drug-eluting balloon angioplasty and vein bypass surgery in diabetic patients with critical limb ischemia due to infrapopliteal arterial disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- Vein bypass surgery first strategy and Endovascular treatment first (drug coated balloon angioplasty) strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Mar 2020to 1 Jan 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with type 2 diabetes mellitus
- Severe limb ischemia (Rutherford class >=4) due to infrapopliteal, +/- popliteal disease [ a.tibialis anterior, tr.tibioperonealis, a.peronea, a.tibialis posterior, a.dorsalis pedis stenosis or occlusion (50%-100%; >40mm in length); leasion may involve a.poplitea P1-P3 segment; have adequate inflow and outflow to support infrapopliteal intervention (diagnostic imaging); suitable for both vein bypass and best endovascular treatment following; angiography diagnostic imaging and ultrasound examination of vein conduit.]
Who cannot join
- Requires primary limb amputation
- Acute limb ischemia
- Anticipated life expectancy of <2 years
- Unsuitable for either revascularisation strategy
- Severe concomitant disease (acute coronary ischemic event, brain ischemic event, cognitive disorder, active oncology process)
Trial locations and contacts
1 site in 1 country.
Džilda Veličkienė, Prof contact
Lithuania1 site, 1 recruiting
- Recruiting
Lithuanian University of Health Sciences
Kaunas, LT, 50161
Vaiva Lesauskaitė, Prof, (8 37) 32 72 06, vaiva.lesauskaite@lsmuni.lt
Viktoras Šliaužys
About this study
The aim of this study is to evaluate the outcomes of drug-eluting balloon angioplasty and vein bypass surgery in diabetic patients with critical limb ischemia due to infrapopliteal arterial disease.
Read the detailed description
Objective: To consider the clinical outcomes of drug-coated ballon angioplasty and vein bypass surgery in terms of amputation-free survival, overall survival, relief of symptoms, quality of life and to determine if limb revascularization contributes to diabetic peripheral neuropathy (DPN).
All patients with type 2 diabetes mellitus and severe limb ischemia reffered to multidisciplinary diabetic foot team or endocrinology or vascular units can be considered.
To be eligible for randomization, peripheral arterial occlusive disease must be located infra-popliteally; patients must have adequate inflow and outflow to support infrapopliteal interventions; have a good superficial vein for bypass surgery. If the patient is suitable for both treatment arms, they will be invited to enter the trial.
If patient is suitable for both revascularization techniques randomization will be performed after diagnostic angiogram submission
Patient will be randomised to one of the following groups:
- Vein bypass surgery first strategy B. Endovascular treatment first (drug coated balloon angioplasty) strategy
Outcomes will be recorded at 1, 3, 6, 9, 12, 18, 24 month after revascularisation procedure. Information collected will include further interventions (vascular, non-vascular), hospitalisations (for whatever reason), other health problems, clinical and haemodinamic status of limbs, funcional status, quality of life, neuropathy.
- Conditions
- Critical Limb Ischemia
- Being tested
- Vein bypass surgery first strategy, Endovascular treatment first (drug coated balloon angioplasty) strategy
- 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.
Vein bypass surgery first strategyProcedure or surgery
Vein bypass will be performed with standart anaesthetic and surgical techniques using reversed great saphenous vein conduit. Location of proximal and distal anastomosis will be recorded. Post surgery completion angiography imaging will be performed.
Endovascular treatment first (drug coated balloon angioplasty) strategyProcedure or surgery
Endovascular treatment using drug-coated balloons will be performed under local anaesthetic via common femoral artery. Final angiography imaging will be demonstrated.
| Study group | Role | What they receive |
|---|---|---|
| Vein bypass surgery first strategy | Active comparator | Not described Receives: Procedure: Vein bypass surgery first strategy |
| Endovascular treatment first (drug coated balloon angioplasty) strategy | Active comparator | Not described Receives: Procedure: Endovascular treatment first (drug coated balloon angioplasty) strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary, primary-assisted and secondary patency
Clinical and ultrasound assesment
Measured: 24 months
Secondary outcomes (13)
Ischemic symptoms
Fontaine classification: I asymptomatic; IIa mild claudication; IIb moderate-to-severe claudication; III rest pain; IV ulceration or gangrene.
Rutherford classification: 0 asymptomatic; 1 mild claudication; 2 moderate claudication; 3 severe claudication; 4 rest pain; 5 minor tissue loss; 6 severe tissue loss or gangrene.
Measured: 24 months
Ankle-brachial index (ABI)
Ratio of the blood pressure at the ankle to the blood pressure in the upper arm. Norm 1.0-1.4
Measured: 24 months
Toe-brachial index (TBI)
Ratio of the blood pressure of the great toe to the blood pressure in the upper arm. Norm 1.0-1.4
Measured: 24 months
Transcutaneous oxygen tension (TcPO2)
A noninvasive test that directly measures the oxygen level of tissue beneath the skin. A TcPO2 greater than 55 mmHg is considered normal regardless of the site of measurement, whereas a value of 40 mmHg is the critical value below which wound healing is impaired and ischemia develops.
Measured: 24 months
Healing of tissue loss (ulcers, gangrene)
Clinical examination and photo documentation.
Measured: 24 months
Re- and cross-over intervention rates
Measured: 24 months
Major and minor amputation rates
Measured: 24 months
In-hospital morbidity/mortality and overall survival
Measured: 24 months
Relief of pain: Visual analog scale (VAS)
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain).
Measured: 24 months
Quality of life: EQ-5D-5L questionaire
Descriptive system for health-related quality of life states in adults, consisting of five dimensions (Mobility, Self-care, Usual activities, Pain \& discomfort, Anxiety \& depression), each of which has five severity levels that are described by statements appropriate to that dimension.
Measured: 24 months
Diabetic neuropathy dinamics: clinical examination of foot sensation
Full hypoesthesia; Partial hypoesthesia; No changes; + Assymetry.
Measured: 24 months
Diabetic neuropathy dinamics: neurometer
Perception threshold measurement. Neurometer® determines three sub-types of nerve fiber by producing transcutaneous electrical stimuli at frequencies of 2000, 250 and 5 Hz.
Measured: 24 months
Diabetic neuropathy dinamics: electroneuromiography
Diagnostic procedure that evaluates the health condition of muscles and the nerve cells that control them. A nerve conduction velocity between 50 and 60 meters per second is generally considered in the normal range.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Mar 2020
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment will consist of two treatment modalities: 1) Vein bypass surgery first strategy; 2) Endovascular treatment first (drug coated balloon angioplasty) strategy
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viktoras Šliaužys, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760119
- Sponsor's protocol ID
- VS3005
- Status last verified
- Feb 2021
- First submitted
- 22 Jan 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Eluting Balloon Angioplasty Versus Bypass Surgery as First-Line Strategies in Infrageniculate Arterial Disease for Critical Limb Ischemia in Type 2 Diabetic Pacients: a Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04760119
- Acronym / sponsor ID
- VS3005
- Conditions
- Critical Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 18 Feb 2021 (actual)
- 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.
The aim of this study is to evaluate the outcomes of drug-eluting balloon angioplasty and vein bypass surgery in diabetic patients with critical limb ischemia due to infrapopliteal arterial disease.
Detailed description
Objective: To consider the clinical outcomes of drug-coated ballon angioplasty and vein bypass surgery in terms of amputation-free survival, overall survival, relief of symptoms, quality of life and to determine if limb revascularization contributes to diabetic peripheral neuropathy (DPN).
All patients with type 2 diabetes mellitus and severe limb ischemia reffered to multidisciplinary diabetic foot team or endocrinology or vascular units can be considered.
To be eligible for randomization, peripheral arterial occlusive disease must be located infra-popliteally; patients must have adequate inflow and outflow to support infrapopliteal interventions; have a good superficial vein for bypass surgery. If the patient is suitable for both treatment arms, they will be invited to enter the trial.
If patient is suitable for both revascularization techniques randomization will be performed after diagnostic angiogram submission
Patient will be randomised to one of the following groups:
- Vein bypass surgery first strategy B. Endovascular treatment first (drug coated balloon angioplasty) strategy
Outcomes will be recorded at 1, 3, 6, 9, 12, 18, 24 month after revascularisation procedure. Information collected will include further interventions (vascular, non-vascular), hospitalisations (for whatever reason), other health problems, clinical and haemodinamic status of limbs, funcional status, quality of life, neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The treatment will consist of two treatment modalities: 1) Vein bypass surgery first strategy; 2) Endovascular treatment first (drug coated balloon angioplasty) strategy
| Arm | Type | Receives |
|---|---|---|
| Vein bypass surgery first strategy | Active comparator | Procedure: Vein bypass surgery first strategy |
| Endovascular treatment first (drug coated balloon angioplasty) strategy | Active comparator | Procedure: Endovascular treatment first (drug coated balloon angioplasty) strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with type 2 diabetes mellitus
- Severe limb ischemia (Rutherford class >=4) due to infrapopliteal, +/- popliteal disease [ a.tibialis anterior, tr.tibioperonealis, a.peronea, a.tibialis posterior, a.dorsalis pedis stenosis or occlusion (50%-100%; >40mm in length); leasion may involve a.poplitea P1-P3 segment; have adequate inflow and outflow to support infrapopliteal intervention (diagnostic imaging); suitable for both vein bypass and best endovascular treatment following; angiography diagnostic imaging and ultrasound examination of vein conduit.]
Key exclusion criteria (5 listed)
- Requires primary limb amputation
- Acute limb ischemia
- Anticipated life expectancy of <2 years
- Unsuitable for either revascularisation strategy
- Severe concomitant disease (acute coronary ischemic event, brain ischemic event, cognitive disorder, active oncology process)
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 |
|---|---|---|
| Vein bypass surgery first strategyVein bypass will be performed with standart anaesthetic and surgical techniques using reversed great saphenous vein conduit. Location of proximal and distal anastomosis will be recorded. Post surgery completion angiography imaging will be performed. | Procedure or surgery | Vein bypass surgery first strategy |
| Endovascular treatment first (drug coated balloon angioplasty) strategyEndovascular treatment using drug-coated balloons will be performed under local anaesthetic via common femoral artery. Final angiography imaging will be demonstrated. | Procedure or surgery | Endovascular treatment first (drug coated balloon angioplasty) strategy |
Primary outcome
Primary, primary-assisted and secondary patency
Time frame: 24 months
Clinical and ultrasound assesment
13 secondary outcomes
Ischemic symptoms
Time frame: 24 months
Ankle-brachial index (ABI)
Time frame: 24 months
Toe-brachial index (TBI)
Time frame: 24 months
Transcutaneous oxygen tension (TcPO2)
Time frame: 24 months
Healing of tissue loss (ulcers, gangrene)
Time frame: 24 months
Re- and cross-over intervention rates
Time frame: 24 months
Major and minor amputation rates
Time frame: 24 months
In-hospital morbidity/mortality and overall survival
Time frame: 24 months
Relief of pain: Visual analog scale (VAS)
Time frame: 24 months
Quality of life: EQ-5D-5L questionaire
Time frame: 24 months
Diabetic neuropathy dinamics: clinical examination of foot sensation
Time frame: 24 months
Diabetic neuropathy dinamics: neurometer
Time frame: 24 months
Diabetic neuropathy dinamics: electroneuromiography
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No
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.
Džilda Veličkienė, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vein bypass surgery first strategy and Endovascular treatment first (drug coated balloon angioplasty) strategy in people with Critical Limb Ischemia, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 2 inclusion and 5 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 18 Feb 2021. 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 Lithuania. 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.
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?
Contact Viktoras Šliaužys, M.D. (+37064297161, viktoras.sliauzys@lsmuni.lt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary, primary-assisted and secondary patency (time frame: 24 months). 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 18 Feb 2021.