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Remote Endarterectomy vs Remote Endarterectomy + Drug Coated Balloon (DCB) Angioplasty in Patients With the Femoral Artery Occlusive Disease

NCT03142347 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-05-05

No results posted yet for this study

Summary

Comparison effectiveness two methods revascularization of the superficial femoral artery: remote endarterectomy vs. remote endarterectomy supplemented DCB angioplasty in patients with steno-occlusive lesion of the femoro-popliteal segment of TASCII D

Conditions

  • Femoral Artery Occlusion

Interventions

PROCEDURE

Remote endarterectomy

Performed open endarterectomy of the common, deep, initial of superficial femoral artery. Proximal plaque exfoliate as far as possible in the superficial femoral artery. After that, the translational and rotational motions loops under fluoroscopic guidance, continuing detachment of plaque in the antegrade direction to the distal end of plaque. Plastic of arteriotomy wounds performed patches of xenopericardium. Control patency of the arterial vessel is performed intraoperatively by X-ray angiography. When rendering residual stenosis or intimal dissection, limiting blood flow, complemented by endovascular intervention plasticity.

PROCEDURE

Remote endarterectomy + DCB balloon

Performed open endarterectomy of the common, deep, initial of superficial femoral artery. Proximal plaque exfoliate as far as possible in the superficial femoral artery. After that, the translational and rotational motions loops under fluoroscopic guidance, continuing detachment of plaque in the antegrade direction to the distal end of plaque. Plastic of arteriotomy wounds performed patches of xenopericardium. And balloon angioplasty of superficial femoral artery with DCB balloon is perform. Control patency of the arterial vessel is performed intraoperatively by X-ray angiography. When rendering residual stenosis or intimal dissection, limiting blood flow, complemented by endovascular intervention plasticity.

Sponsors & Collaborators

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Principal Investigators

  • Andrey Karpenko · cientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-01-31
Completion
2019-01-31

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 NCT03142347 on ClinicalTrials.gov