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

Meshalkin Research Institute of Pathology of Circulation1 site in 1 country50 target enrollmentJanuary 2017

ConditionsFemoral Artery Occlusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Femoral Artery Occlusion
Sponsor: Meshalkin Research Institute of Pathology of Circulation
Enrollment: 50
Locations: 1
Primary Endpoint: the change of lumen in target vessel
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2017

End Date

January 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Meshalkin Research Institute of Pathology of Circulation

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

the change of lumen in target vessel

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

stenosis or occlusions

Secondary Outcomes

Number of participants with complications in long-term period after the operation.(3 days after the operation, 6 month, 12 month, 2 years)
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)