Atherosclerosis of the Tibial Arteries, Lesion no More Than Two Tibial Arteries, Steno-occlusive Lesion of the Tibial Arteries, Сhronic Ischemia of the Lower Extremities
Conditions
Keywords
radio frequency denervation, tibial arteries, atherosclerosis of the peripheral arteries
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.
Interventions
PROCEDUREangioplasty 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.
PROCEDUREangioplasty tibial arteries augmented radio frequency denervation popliteal artery by the useVessix 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.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
Countries
Russia
Outcome results
None listed