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

Not Applicable

• Conditions: Steno-occlusive Desease of Femoro-popliteal Arterial Segment
• Interventions: Procedure: Open surgery; Procedure: Angioplasty with stenting of the femoral artery

• Registration Number: NCT02948166
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief 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

Detailed Description

Reported local percutaneous angioplasty and stenosis of femoral popliteal arteries indicate that the primary technical and clinical success above 95%. The technical success of recanalization of long occlusions femoral arteries less than 80%. Improvement of endovascular equipment designed for the treatment of total occlusions, increases the technical success of recanalization. The materials of the TASC II summarizes the results of several large studies that presented data on the operated segment artery patency at 56-73,7% within 2 years of observation. An alternative method of revascularization own femoral artery is remote endarterectomy. The two-year primary patency at remote endarterectomy is 86% (Moll F.L., Iio G.H. Closed superficial femoral artery endarterectomy: a 2-year follow up. Cardiovasc Surg. 1997; 5: 398-400). Primary assisted patency for 33 months 88% (Rosenthal D, Martin JD, Schubart PJ, Wellons ED. Remote. superficial femoral artery endarterectomy. J Cardiovasc Surg. (Torino) 2004; 45: 185-192). The length of the occlusion is not a limitation to the use of remote endarterectomy. Primary patency at 31 months was 60%.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-09-25
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-28
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-05
• Primary Completion: 2018-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 174

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 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 angioplasty
• Patients with significant common femoral artery lesion
• Patient refusal to participate or continue to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open surgery	Open surgery	Performed open endarterectomy of the common, deep, initial of superficial femoral artery. 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 arteriotomnyh wounds performed patches of ksenoperikard treated with epoxy compounds. Control patency of the arterial bed is performed intraoperatively by X-ray angiography.
Stenting of the femoral artery	Angioplasty with stenting of the femoral artery	A standard endovascular treatment of the steno-occlusive lesion in femoro-popliteal arterial segment.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with a successful procedure of revascularization.	During the operation.
Number of participants with complications during the operation.	During the operation.
Number of participants with limb salvage	Baseline, 3 days after the operation, 6 month, 12 month, 2, 3 years

Trial Locations

Locations (1)

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