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

NCT ID: NCT03142347

Last Updated: 2017-05-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-01-31

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.

Conditions

Femoral Artery Occlusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Remote endarterectomy

Intervention Type: PROCEDURE

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 xenopericardium. 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.

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.

Group Type: EXPERIMENTAL

Remote endarterectomy + DCB balloon

Intervention Type: PROCEDURE

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 xenopericardium. And balloon angioplasty of superficial femoral artery with DCB balloon is perform. 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.

Interventions

Remote endarterectomy

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 xenopericardium. 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.

Intervention Type: PROCEDURE

Remote endarterectomy + DCB balloon

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 xenopericardium. And balloon angioplasty of superficial femoral artery with DCB balloon is perform. 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.

Intervention Type: PROCEDURE

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 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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meshalkin Research Institute of Pathology of Circulation

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrey Karpenko

Role: STUDY_DIRECTOR

cientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin

Locations

Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology

Novosibirsk, , Russia

Site Status: RECRUITING

Countries

Russia

Central Contacts

Artem Rabtsun

Role: CONTACT

a_rabtsun@meshalkin.ru

+79137078354

Facility Contacts

Artem Rabtsun

Role: primary

a_rabtsun@meshalkin.ru

+79137078354

Other Identifiers

N-RICP-469

Identifier Type: -

Identifier Source: org_study_id