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

Sponsor

Meshalkin Research Institute of Pathology of Circulation (Other)

Overall Status

Unknown status

CT.gov ID

NCT03142347

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Femoral Artery Occlusion	Procedure: Remote endarterectomy Procedure: Remote endarterectomy + DCB balloon	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Remote Endarterectomy vs Remote Endarterectomy Supplement DCB Balloon Angioplasty in Patients With the Femoral Artery Occlusive Disease (TASCII D)

Actual Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Procedure: 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.
Experimental: 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.	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.

Arm

Intervention/Treatment

Active Comparator: 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.

Procedure: 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.

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

the change of lumen in target vessel [Baseline, 3 days after the operation, 6 month, 12 month, 2 years]
stenosis or occlusions

Secondary Outcome Measures

Vessel wall thickness [3 days after the operation, 6 month, 12 month, 2 years]
mm
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology	Novosibirsk		Russian Federation	630055

Sponsors and Collaborators

Meshalkin Research Institute of Pathology of Circulation

Investigators

Study Director: Andrey Karpenko, cientific-Research Institute of Circulation Pathology named after Academician E. Meshalkin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Meshalkin Research Institute of Pathology of Circulation

ClinicalTrials.gov Identifier:

NCT03142347

Other Study ID Numbers:

N-RICP-469

First Posted:

May 5, 2017

Last Update Posted:

May 5, 2017

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Meshalkin Research Institute of Pathology of Circulation

remote endarterectomy

DCB balloon

Study Results

No Results Posted as of May 5, 2017