NCT02825446

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Meshalkin Research Institute of Pathology of Circulation · Network
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-05-01
• Completion: 2020-06-01
• First posted: 2016-07-07
• Last updated: 2020-07-08

Locations

1 site across 1 country: Russia