Status:
UNKNOWN
Full Metall Jacket Multilevel Segment
Lead Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Conditions:
Superficial Femoral Artery Stenosis
Iliac Artery Occlusion
Eligibility:
All Genders
45-80 years
Phase:
NA
Brief Summary
Hypothesis: "Total" endovascular revascularization of a multistory lesion of the iliac-femoral-popliteal segment is safer and a better quality of life is achieved in comparison with hybrid interventio...
Detailed Description
Mortality from cardiovascular disease occupies a leading position worldwide. Patients with atherosclerotic lesions of the peripheral arteries account for 20% of the total number of patients with cardi...
Eligibility Criteria
Inclusion
- patients with multisegment lesions of the iliac-femoral-popliteal segment, with the distal border of the lesion above the slit of the knee joint.
- chronic ischemia 3-6 (according to Rutherford),
- the satisfactory direction of the outflow.
- Patients who gave consent to participate in this study
Exclusion
- Chronic occlusion of the SFA at least 2cm
- Heavy calcification of SFA • Infection in the area of the access artery
- Expressed, more than 50% stenotic lesions of the infrarenal aorta
- Prolonged loss (TASC D) iliac artery on the side of revascularization
- aneurysmal widening of the infrarenal aorta and iliac arteries
- Hemodynamically significant lesions DFA
- Chronic heart failure III-IV functional class NYHA classification;
- decompensated Chronic "pulmonary" heart; • Severe hepatic or renal insufficiency (bilirubin \>35 mmol/l, glomerular filtration rate \<60 ml/min);
- Polyvalent drug Allergy;
- Malignant cancer in the terminal stage with a projected life span of 6 months;
- Acute stroke;
- a Pronounced calcification of the arteries of the lower limbs;
- Patients with significant lesions of the common femoral artery
- the Refusal of a patient to participate or continue to participate in the study.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 5 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04461496
Start Date
June 30 2020
End Date
June 5 2025
Last Update
July 13 2020
Active Locations (1)
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1
Meshalkin Research Institute of Pathology of Circulation
Novosibirsk, Novosibirskaya Obl, Russia, 630055