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

NCT02948166 | Unknown

• 1 other identifier: N-RICP-468
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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

Conditions

Steno-occlusive Desease of Femoro-popliteal Arterial Segment

Keywords

remote endarterectomy; Angioplasty with stenting of the superficial femoral artery

Outcome Measures

Primary Outcomes (1)

• the change of lumen in target vessel

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

Secondary Outcomes (3)

• 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

Study Arms (2)

Stenting of the femoral artery

ACTIVE COMPARATOR

A standard endovascular treatment of the steno-occlusive lesion in femoro-popliteal arterial segment.

Procedure: Angioplasty with stenting of the femoral artery

Open surgery

EXPERIMENTAL

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

Interventions

Angioplasty with stenting of the femoral artery PROCEDURE

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.

Stenting of the femoral artery

Open surgery 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 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.

Open surgery

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 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

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

MeSH Terms

Interventions

Angioplasty; Conversion to Open Surgery

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques; Endoscopy

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: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2016
• First Posted: October 28, 2016
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2019
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

RU (1)