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Remote Endarterectomy and Endovascular Treatments in Patients With the Femoral Artery Occlusive Disease

NCT02948166 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2017-05-05

No results posted yet for this study

Summary

Comparison of two methods for revascularization of the superficial femoral artery: remote endarterectomy vs. stenting of the superficial femoral artery cin patients with steno-occlusive lesion of the femoro-popliteal segment of TASC C, D

Conditions

  • Steno-occlusive Desease of Femoro-popliteal Arterial Segment

Interventions

PROCEDURE

Angioplasty with stenting of the femoral artery

A standard endovascular exposure is carried out under local anesthesia and a lesioned arterial segment is visualized. Stenosis or artery occlusion is passed by the hydrophilic guide. During the occlusion transluminal or subintimal artery recanalization (most frequently mixed) is conduced. Then balloon angioplasty of stenosis or occlusion are carried out. After the angiographic control if necessary stent (balloon expandable or self-expanding) of all the extension is mounted.

PROCEDURE

Open surgery

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 ksenoperikard treated with epoxy compounds. 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
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-01-31
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 NCT02948166 on ClinicalTrials.gov