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

Femoral Artery Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03142347
• Other study ID #: N-RICP-469
• Status: Recruiting
• Phase: N/A
• First received: May 3, 2017
• Last updated: May 3, 2017
• Start date: January 2017
• Est. completion date: January 2019

Study information

• Verified date: May 2017
• Source: Meshalkin Research Institute of Pathology of Circulation
• Contact: Artem Rabtsun
• Phone: +79137078354
• Email: a_rabtsun[@]meshalkin.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Femoral Artery Occlusion

Intervention

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.
• 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.

Locations

Country	Name	City	State
Russian Federation	Federal State Institution Academician E.N.Meshalkin Novosibirsk State Research Institute Of Circulation Pathology Rusmedtechnology	Novosibirsk

Sponsors (1)

Lead Sponsor	Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of lumen in target vessel	stenosis or occlusions	Baseline, 3 days after the operation, 6 month, 12 month, 2 years
Secondary	Vessel wall thickness	mm	3 days after the operation, 6 month, 12 month, 2 years
Secondary	Number of participants with limb salvage		3 days after the operation, 6 month, 12 month, 2 years
Secondary	Number of participants with complications in long-term period after the operation.		3 days after the operation, 6 month, 12 month, 2 years