Сhronic Ischemia of the Lower ExtremitiesATRFPANCT02825446
Angioplasty of the Tibial Arteries Augmented Radio Frequency Denervation of the Popliteal Artery
A study testing angioplasty tibial arteries and angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon" in people with Сhronic Ischemia of the Lower Extremities and Atherosclerosis of the Tibial Arteries, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
Angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will remove the spasm with macro and microcirculatory blood flow, which increases revascularization patency of tibial arteries. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Сhronic Ischemia of the Lower Extremities, Atherosclerosis of the Tibial Arteries, Lesion no More Than Two Tibial Arteries
- What is being tested?
- angioplasty tibial arteries and angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteRussia
- Study dates
- May 2016to Jun 2020
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic lower limb ischemia 3-6 degree by Rutherford;
- Stenosis or occlusion of no more than 2 tibial arteries;
- Stenosis of the tibial arteries more than 70 %;
- Duration stenosis or occlusion no more than 70 mm;
Who cannot join
- Diabetes mellitus type 2
- Occlusion or stenosis of all tibial arteries
- Expressed calcification of tibial arteries angioplasty tolerant
- Hemodynamically significant stenosis of the popliteal artery;
- Chronic heart failure of III-IV functional class by NYHA classification;
- Decompensated chronic "pulmonary" heart;
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- Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);
- Polyvalent drug allergy;
- Cancer in the terminal stage with a life expectancy less than 6 months;
- Patient refusal to participate or continue to participate in the study;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Prospective Study of Two Methods of Revascularization of Tibial Arteries: Angioplasty Tibial Arteries, and Angioplasty Tibial Artery, Augmented by Radio Frequency Denervation Popliteal Artery in Patients With Steno-occlusive Lesion of the Tibial Arteries
Angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will remove the spasm with macro and microcirculatory blood flow, which increases revascularization patency of tibial arteries.
- Conditions
- Сhronic Ischemia of the Lower Extremities, Atherosclerosis of the Tibial Arteries, Lesion no More Than Two Tibial Arteries, Steno-occlusive Lesion of the Tibial Arteries
- Being tested
- angioplasty tibial arteries, angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"
- Keywords
- radio frequency denervation, tibial arteries, atherosclerosis of the peripheral arteries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angioplasty tibial arteriesProcedure or surgery
Under local anesthesia using the standard endovascular access and renders the affected arterial segment. Are stenosis or occlusion of the artery, the hydrophilic guide. Occlusion or subintimal perform transluminal recanalization of the artery. Then do balloon angioplastic stenosis or occlusion.
Drug therapy includes the administration of aspirin before the procedure (160-300 mg/day) starting at least one day, and heparin during the procedure (5000 IU intravenously). After the procedure, all patients are administered aspirin (100 mg daily) for a long time.
angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"Procedure or surgery
Under local anesthesia using the standard endovascular access and renders the affected arterial segment. Are stenosis or occlusion of the artery, the hydrophilic guide. Occlusion or subintimal perform transluminal recanalization of the artery. Then do balloon angioplastic stenosis or occlusion. Then in 3 portion of the popliteal artery starts ablation by the use "Vessix Renal Denervation System Balloon" performed radiofrequency denervation. After removal of the balloon, control angiography is performed.
Drug therapy includes the administration of aspirin before the procedure (160-300 mg/day) starting at least one day, and heparin during the procedure (5000 IU intravenously). After the procedure, all patients are administered aspirin (100 mg daily) for a long time.
| Study group | Role | What they receive |
|---|---|---|
| angioplasty tibial arteries | Active comparator | Not described Receives: Procedure: angioplasty tibial arteries |
| radio frequency denervation popliteal artery by the use | Experimental | radio frequency denervation popliteal artery "Vessix Renal Denervation System Balloon" Receives: Procedure: angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon" |
What is being measured
The primary outcome is the main question the study is designed to answer.
the absence of thrombosis or stenosis of the popliteal artery
during the whole period of observation, confirmation of patency of the arterial ultrasound of the operated segment as well as such parameters as flow rate, presence of stenosis (%) or thrombosis
Measured: 12 mounth after intervention
Secondary outcomes (5)
Primary patency after intervention
during the whole period of observation, confirmation of patency of the arterial ultrasound of the operated segment as well as such parameters as flow rate, presence of stenosis (%) or thrombosis
Measured: 12-mounth after intervention
Secondary patency after intervention
during the whole period of observation, confirmation of patency of the arterial ultrasound of the operated segment as well as such parameters as flow rate, presence of stenosis (%) or thrombosis
Measured: 12-mounth after intervention
Number of participants with limb salvage
Number of participants with limb salvage
Measured: 12 mounth after intervention
Laser Doppler Flowmetry
to assess the microcirculation of the lower limbs use such parameters as:
- the time until the maximal post-occlusive blood flow
- maximal post-occlusive blood flow
- post-occlusive blood flow increase of
Measured: 12 mounth after intervention
Transcutaneous oxygen tension
to assess the microcirculation of the lower limbs use a level transcutaneous oxygen tension (%)
Measured: 12 mounth after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018
- Study completionJun 2020
Why it stopped: a significant number of patients were not selected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Сhronic Ischemia of the Lower ExtremitiesStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Andrey Karpenko, Study director, Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825446
- Sponsor's protocol ID
- N-RICP-873
- Acronym
- ATRFPA
- Status last verified
- May 2020
- First submitted
- 28 Jun 2016
- Last updated
- 8 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Prospective Study of Two Methods of Revascularization of Tibial Arteries: Angioplasty Tibial Arteries, and Angioplasty Tibial Artery, Augmented by Radio Frequency Denervation Popliteal Artery in Patients With Steno-occlusive Lesion of the Tibial Arteries
- ClinicalTrials.gov ID
- NCT02825446
- Acronym / sponsor ID
- ATRFPA / N-RICP-873
- Conditions
- Сhronic Ischemia of the Lower Extremities, Atherosclerosis of the Tibial Arteries, Lesion no More Than Two Tibial Arteries, Steno-occlusive Lesion of the Tibial Arteries
- Keywords
- radio frequency denervation, tibial arteries, atherosclerosis of the peripheral arteries
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: a significant number of patients were not selected
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- May 2016 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 7 Jul 2016 (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.
Angioplasty augmented radiofrequency denervation popliteal artery, in our opinion, will remove the spasm with macro and microcirculatory blood flow, which increases revascularization patency of tibial arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| angioplasty tibial arteries | Active comparator | Procedure: angioplasty tibial arteries |
| radio frequency denervation popliteal artery by the use | Experimental | Procedure: angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"radio frequency denervation popliteal artery "Vessix Renal Denervation System Balloon" |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic lower limb ischemia 3-6 degree by Rutherford;
- Stenosis or occlusion of no more than 2 tibial arteries;
- Stenosis of the tibial arteries more than 70 %;
- Duration stenosis or occlusion no more than 70 mm;
Key exclusion criteria (10 listed)
- Diabetes mellitus type 2
- Occlusion or stenosis of all tibial arteries
- Expressed calcification of tibial arteries angioplasty tolerant
- Hemodynamically significant stenosis of the popliteal artery;
- Chronic heart failure of III-IV functional class by NYHA classification;
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 |
|---|---|---|
| angioplasty tibial arteriesUnder local anesthesia using the standard endovascular access and renders the affected arterial segment. Are stenosis or occlusion of the artery, the hydrophilic guide. Occlusion or subintimal perform transluminal recanalization of the artery. Then do balloon angioplastic stenosis or occlusion. Drug therapy includes the administration of aspirin before the procedure (160-300 mg/day) starting at least one day, and heparin during the procedure (5000 IU intravenously). After the procedure, all patients are administered aspirin (100 mg daily) for a long time. | Procedure or surgery | angioplasty tibial arteries |
| angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"Under local anesthesia using the standard endovascular access and renders the affected arterial segment. Are stenosis or occlusion of the artery, the hydrophilic guide. Occlusion or subintimal perform transluminal recanalization of the artery. Then do balloon angioplastic stenosis or occlusion. Then in 3 portion of the popliteal artery starts ablation by the use "Vessix Renal Denervation System Balloon" performed radiofrequency denervation. After removal of the balloon, control angiography is performed. Drug therapy includes the administration of aspirin before the procedure (160-300 mg/day) starting at least one day, and heparin during the procedure (5000 IU intravenously). After the procedure, all patients are administered aspirin (100 mg daily) for a long time. | Procedure or surgery | radio frequency denervation popliteal artery by the use |
Primary outcome
the absence of thrombosis or stenosis of the popliteal artery
Time frame: 12 mounth after intervention
during the whole period of observation, confirmation of patency of the arterial ultrasound of the operated segment as well as such parameters as flow rate, presence of stenosis (%) or thrombosis
5 secondary outcomes
Primary patency after intervention
Time frame: 12-mounth after intervention
Secondary patency after intervention
Time frame: 12-mounth after intervention
Number of participants with limb salvage
Time frame: 12 mounth after intervention
Laser Doppler Flowmetry
Time frame: 12 mounth after intervention
Transcutaneous oxygen tension
Time frame: 12 mounth after intervention
Results and safety
The study was stopped early (reason given: a significant number of patients were not selected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
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.
Andrey Karpenko study director
Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing angioplasty tibial arteries and angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon" in people with Сhronic Ischemia of the Lower Extremities and Atherosclerosis of the Tibial Arteries, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 10 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: stopped early, as of the sponsor's last update on 8 Jul 2020. 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 Russia. 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?
The study was stopped early (reason given: a significant number of patients were not selected). 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?
the absence of thrombosis or stenosis of the popliteal artery (time frame: 12 mounth after intervention). 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 8 Jul 2020.