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

Study Overview
=================
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%.

Official Title
-----------------
Prospective Randomized Clinical Trial of the Remote Endarterectomy and the Femoral Arteries Endovascular Treatments in Patients With the Femoral Artery Occlusive Disease (TASC C, D)

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

Intervention / Treatment
-----------------
* Procedure: Angioplasty with stenting of the femoral artery
* Procedure: Open surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stenting of the femoral artery<br>A standard endovascular treatment of the steno-occlusive lesion in femoro-popliteal arterial segment. | Procedure: Angioplasty with stenting of the femoral artery<br>* 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.<br>|
| Experimental: Open surgery<br>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. | Procedure: Open surgery<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of lumen in target vessel |  | Baseline, 3 days after the operation, 6 month, 12 month, 2, 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
remote endarterectomy, Angioplasty with stenting of the superficial femoral artery