Angioplasty of the Tibial Arteries Augmented Radio Frequency Denervation of the Popliteal Artery (ATRFPA)

Meshalkin Research Institute of Pathology of Circulation

Status

Terminated

Conditions

Steno-occlusive Lesion of the Tibial Arteries

Lesion no More Than Two Tibial Arteries

Atherosclerosis of the Tibial Arteries

Сhronic Ischemia of the Lower Extremities

Treatments

Procedure: angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"

Procedure: angioplasty tibial arteries

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT02825446

N-RICP-873

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;