Back to resultsAngioplasty of the Tibial Arteries Augmented Radio Frequency Denervation of the Popliteal Artery (ATRFPA)
Primary Purpose
Сhronic Ischemia of the Lower Extremities, Atherosclerosis of the Tibial Arteries, Lesion no More Than Two Tibial Arteries
Status
Terminated
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
angioplasty tibial arteries
angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"
Sponsored by
About this trial
This is an interventional treatment trial for Сhronic Ischemia of the Lower Extremities focused on measuring radio frequency denervation, tibial arteries, atherosclerosis of the peripheral arteries
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
- 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;
Sites / Locations
- NRICP
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
angioplasty tibial arteries
radio frequency denervation popliteal artery by the use
Arm Description
radio frequency denervation popliteal artery "Vessix Renal Denervation System Balloon"
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Number of participants with limb salvage
Number of participants with limb salvage
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
Transcutaneous oxygen tension
to assess the microcirculation of the lower limbs use a level transcutaneous oxygen tension (%)
Full Information
NCT ID
NCT02825446
First Posted
June 28, 2016
Last Updated
July 6, 2020
Sponsor
Meshalkin Research Institute of Pathology of Circulation
1. Study Identification
Unique Protocol Identification Number
NCT02825446
Brief Title
Angioplasty of the Tibial Arteries Augmented Radio Frequency Denervation of the Popliteal Artery
Acronym
ATRFPA
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
a significant number of patients were not selected
Study Start Date
May 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
angioplasty tibial arteries
Arm Type
Active Comparator
Arm Title
radio frequency denervation popliteal artery by the use
Arm Type
Experimental
Arm Description
radio frequency denervation popliteal artery "Vessix Renal Denervation System Balloon"
Intervention Type
Procedure
Intervention Name(s)
angioplasty tibial arteries
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"
Intervention Description
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.
Primary Outcome Measure Information:
Title
the absence of thrombosis or stenosis of the popliteal artery
Description
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
Time Frame
12 mounth after intervention
Secondary Outcome Measure Information:
Title
Primary patency after intervention
Description
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
Time Frame
12-mounth after intervention
Title
Secondary patency after intervention
Description
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
Time Frame
12-mounth after intervention
Title
Number of participants with limb salvage
Description
Number of participants with limb salvage
Time Frame
12 mounth after intervention
Title
Laser Doppler Flowmetry
Description
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
Time Frame
12 mounth after intervention
Title
Transcutaneous oxygen tension
Description
to assess the microcirculation of the lower limbs use a level transcutaneous oxygen tension (%)
Time Frame
12 mounth after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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;
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrey Karpenko
Organizational Affiliation
Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology
Official's Role
Study Director
Facility Information:
Facility Name
NRICP
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Angioplasty of the Tibial Arteries Augmented Radio Frequency Denervation of the Popliteal Artery
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