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

Not Applicable

• Conditions: Femoral Artery Occlusion
• Interventions: Procedure: Remote endarterectomy + DCB balloon; Procedure: Remote endarterectomy

• Registration Number: NCT03142347
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief 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

Detailed Description

Given that more and more devices appear to deliver cytotoxic drugs into the depth of atherosclerotic plaque, it is interesting to study the effect of these drugs when applied directly after plaque removal.

Study Timeline

• Study Start: 2017-01
• Status Verified: 2017-05
• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-03
• Last Update Submitted: 2017-05-03
• Study First Posted: 2017-05-05
• Last Update Posted: 2017-05-05
• Primary Completion: 2018-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with occlusive lesions of C and D type femoral artery and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford)
• Patients who consented to participate in this study.

Exclusion Criteria

• Chronic heart failure of III-IV functional class by New York Heart Association (NYHA) classification.
• Decompensated chronic "pulmonary" heart
• Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min);
• Polyvalent drug allergy
• Cancer in the terminal stage with a life expectancy less than 6 months;
• Acute ischemic
• Expressed aortic calcification tolerant to remote endarterectomy
• Patient refusal to participate or continue to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote endarterectomy + DCB balloon	Remote endarterectomy + DCB balloon	Open endarterectomy of the common, deep, initial of superficial femoral artery was performed. Delamination factory complex into the lumen of the loop. 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 arteriotomy wounds performed patches of xenopericardium. And balloon angioplasty of superficial femoral artery with DCB balloon is perform. Control patency of the arterial lumen is performed intraoperatively by X-ray angiography.
Remote endarterectomy	Remote endarterectomy	Open endarterectomy of the common, deep, initial of superficial femoral artery was performed. Delamination factory complex into the lumen of the loop. 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 arteriotomy wounds performed patches of xenopericardium. Control patency of the arterial lumen is performed intraoperatively by X-ray angiography.

Primary Outcome Measures

Name	Time	Method
the change of lumen in target vessel	Baseline, 3 days after the operation, 6 month, 12 month, 2 years	stenosis or occlusions

Secondary Outcome Measures

Name	Time	Method
Number of participants with complications in long-term period after the operation.	3 days after the operation, 6 month, 12 month, 2 years
Vessel wall thickness	3 days after the operation, 6 month, 12 month, 2 years	mm
Number of participants with limb salvage	3 days after the operation, 6 month, 12 month, 2 years

Trial Locations

Locations (1)

Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology; 🇷🇺 Novosibirsk, Russian Federation