Femoral Artery Occlusion
Conditions
Keywords
remote endarterectomy, DCB balloon
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.
Interventions
PROCEDURERemote 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.
PROCEDURERemote 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.
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change of lumen in target vessel | Baseline, 3 days after the operation, 6 month, 12 month, 2 years | stenosis or occlusions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Russia
Contacts
Primary ContactArtem Rabtsun
Outcome results
None listed