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

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

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 Overview

• Status: Terminated
• 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 use"Vessix Renal Denervation System Balloon"

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • NRICP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: angioplasty tibial arteries	Procedure: angioplasty tibial arteries; 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.
Experimental: radio frequency denervation popliteal artery by the use; radio frequency denervation popliteal artery "Vessix Renal Denervation System Balloon"	Procedure: angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the use"Vessix Renal Denervation System Balloon"; 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.

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

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Investigators: Study Director: Andrey Karpenko, Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: July 6, 2016
• First Posted (Estimate): July 7, 2016

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 6, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: atherosclerosis of the peripheral arteries; radio frequency denervation; tibial arteries
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Ischemia; Atherosclerosis
• Other Study ID Numbers: N-RICP-873