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

Not Applicable

Terminated

• Conditions: Сhronic Ischemia of the Lower Extremities; Lesion no More Than Two Tibial Arteries; Atherosclerosis of the Tibial Arteries; Steno-occlusive Lesion of the Tibial Arteries
• Interventions: Procedure: angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"; Procedure: angioplasty tibial arteries

• Registration Number: NCT02825446
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-07-06
• Study First Posted: 2016-07-07
• Primary Completion: 2018-05
• Status Verified: 2020-05
• Study Completion: 2020-06
• Last Update Submitted: 2020-07-06
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
radio frequency denervation popliteal artery by the use	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"
angioplasty tibial arteries	angioplasty tibial arteries	-

Primary Outcome Measures

Name	Time	Method
the absence of thrombosis or stenosis of the popliteal artery	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

Secondary Outcome Measures

Name	Time	Method
Primary patency after intervention	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
Secondary patency after intervention	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
Number of participants with limb salvage	12 mounth after intervention	Number of participants with limb salvage
Laser Doppler Flowmetry	12 mounth after intervention	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	12 mounth after intervention	to assess the microcirculation of the lower limbs use a level transcutaneous oxygen tension (%)

Trial Locations

Locations (1)

NRICP; 🇷🇺 Novosibirsk, Russian Federation