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

NCT03142347 | Unknown

• 1 other identifier: N-RICP-469
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Femoral Artery Occlusion

Keywords

remote endarterectomy; DCB balloon

Outcome Measures

Primary Outcomes (1)

• the change of lumen in target vessel

  stenosis or occlusions

  Baseline, 3 days after the operation, 6 month, 12 month, 2 years

Secondary Outcomes (3)

• Vessel wall thickness

  3 days after the operation, 6 month, 12 month, 2 years

• Number of participants with limb salvage

  3 days after the operation, 6 month, 12 month, 2 years

• Number of participants with complications in long-term period after the operation.

  3 days after the operation, 6 month, 12 month, 2 years

Study Arms (2)

Remote endarterectomy

ACTIVE COMPARATOR

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.

Procedure: Remote endarterectomy

Remote endarterectomy + DCB balloon

EXPERIMENTAL

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.

Procedure: Remote endarterectomy + DCB balloon

Interventions

Remote endarterectomy 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

Remote endarterectomy + DCB balloon 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.

Remote endarterectomy + DCB balloon

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

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

Novosibirsk, 630055, Russia

RECRUITING

Study Officials

• Andrey Karpenko

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

  STUDY DIRECTOR

Central Study Contacts

Artem Rabtsun

CONTACT

+79137078354; a_rabtsun@meshalkin.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 5, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

RU (1)