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

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)

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

Study Overview

• Status: Unknown
• Conditions: Steno-occlusive Desease of Femoro-popliteal Arterial Segment
• Intervention / Treatment: Procedure: Angioplasty with stenting of the femoral artery; Procedure: Open surgery

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 Type: Interventional
• Enrollment (Anticipated): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Recruiting
    • Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stenting of the femoral artery; A standard endovascular treatment of the steno-occlusive lesion in femoro-popliteal arterial segment.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: September 25, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): October 28, 2016

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Angioplasty with stenting of the superficial femoral artery; remote endarterectomy
• Other Study ID Numbers: N-RICP-468