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

NCT02825446 | Terminated

• 1 other identifier: N-RICP-873
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Keywords

radio frequency denervation; tibial arteries; atherosclerosis of the peripheral arteries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Primary patency after intervention

  12-mounth after intervention

• Secondary patency after intervention

  12-mounth after intervention

• Number of participants with limb salvage

  12 mounth after intervention

• Laser Doppler Flowmetry

  12 mounth after intervention

• Transcutaneous oxygen tension

  12 mounth after intervention

Study Arms (2)

angioplasty tibial arteries

ACTIVE COMPARATOR

Procedure: angioplasty tibial arteries

radio frequency denervation popliteal artery by the use

EXPERIMENTAL

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"

Interventions

angioplasty tibial arteries 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. 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

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.

radio frequency denervation popliteal artery by the use

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

NRICP

Novosibirsk, 630055, Russia

Location

Study Officials

• Andrey Karpenko

  Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: July 7, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-05

Locations

RU (1)