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

Meshalkin Research Institute of Pathology of Circulation15 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

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

Interventions

angioplasty tibial arteriesPROCEDURE

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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;

Locations (1)

NRICP

Novosibirsk, Russia

Outcomes

Primary Outcomes

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

Time frame: 12 mounth after intervention

Secondary Outcomes

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

Time frame: 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

Time frame: 12-mounth after intervention

Number of participants with limb salvage

Time frame: 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

Time frame: 12 mounth after intervention

Transcutaneous oxygen tension

to assess the microcirculation of the lower limbs use a level transcutaneous oxygen tension (%)

Time frame: 12 mounth after intervention

Data from ClinicalTrials.gov

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