Angioplasty of the Tibial Arteries Augmented Radio Frequency Denervation of the Popliteal Artery

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Procedure: angioplasty tibial arteries
* Procedure: angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the useVessix Renal Denervation System Balloon


Participation Criteria
=================
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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: angioplasty tibial arteries<br> | Procedure: angioplasty tibial arteries<br>* 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.<br>|
| Experimental: radio frequency denervation popliteal artery by the use<br>radio frequency denervation popliteal artery Vessix Renal Denervation System Balloon | Procedure: angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the useVessix Renal Denervation System Balloon<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 mounth after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 12-mounth after intervention | 
| Number of participants with limb salvage | Number of participants with limb salvage | 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 | 12 mounth after intervention | 
| Transcutaneous oxygen tension | to assess the microcirculation of the lower limbs use a level transcutaneous oxygen tension (%) | 12 mounth after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radio frequency denervation, tibial arteries, atherosclerosis of the peripheral arteries