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

NCT ID: NCT02825446

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

angioplasty tibial arteries

Group Type: ACTIVE_COMPARATOR

angioplasty tibial arteries

Intervention Type: 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.

radio frequency denervation popliteal artery by the use

radio frequency denervation popliteal artery "Vessix Renal Denervation System Balloon"

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrey Karpenko

Role: STUDY_DIRECTOR

Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology

Locations

NRICP

Novosibirsk, , Russia

Countries

Russia

Other Identifiers

N-RICP-873

Identifier Type: -

Identifier Source: org_study_id