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

Meshalkin Research Institute of Pathology of Circulation

Status: Unknown

Conditions: Steno-occlusive Desease of Femoro-popliteal Arterial Segment

Treatments: Procedure: Open surgery; Procedure: Angioplasty with stenting of the femoral artery

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02948166

N-RICP-468

Details and patient eligibility

About

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

Full 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%.

Enrollment: 174 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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174 participants in 2 patient groups

Stenting of the femoral artery

Active Comparator group

Description:

A standard endovascular treatment of the steno-occlusive lesion in femoro-popliteal arterial segment.

Treatment:

Procedure: Angioplasty with stenting of the femoral artery

Open surgery

Experimental group

Description:

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.

Treatment:

Procedure: Open surgery