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

NCT02825446 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-07-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Principal Investigators

  • Andrey Karpenko · Academician EN Meshalkin Novosibirsk State Budget Research Institute of Circulation Pathology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-05-31
Completion
2020-06-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02825446 on ClinicalTrials.gov