Full Metall Jacket Multilevel Segment (NCT04461496) | Clinical Trial Compass
UnknownNot Applicable
Full Metall Jacket Multilevel Segment
Russia100 participantsStarted 2020-06-30
Plain-language 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 intervention.
The lack of damage to the skin avoids complications in the postoperative and remote periods of observation, thereby improving the quality of life
Who can participate
Age range45 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Efficacy of the procedure
Timeframe: 24 months
2
Safety of the procedure
Timeframe: 30 days
3
Safety of the procedure
Timeframe: 24 months
Trial details
NCT IDNCT04461496
SponsorMeshalkin Research Institute of Pathology of Circulation