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a significant number of patients were not selected
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| angioplasty tibial arteries | Active Comparator |
| |
| radio frequency denervation popliteal artery by the use | Experimental | radio frequency denervation popliteal artery "Vessix Renal Denervation System Balloon" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrey Karpenko | Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NRICP | Novosibirsk | 630055 | Russia |
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|
| 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. |
|
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:
| 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 |