Superficial Femoral Artery Stenosis Clinical Trial
— FMJSFAOfficial title:
The Pilot Clinical Trial Comparing the Efficacy of Single-stage Multilevel Revascularization of the Iliac-femoral-popliteal Segment Using the FULL METALL JACKET Technology in Comparison With the Hybrid Revascularization Procedure
NCT number | NCT04461496 |
Other study ID # | FMJ |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 30, 2020 |
Est. completion date | June 5, 2025 |
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
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 5, 2025 |
Est. primary completion date | June 5, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Meshalkin Research Institute of Pathology of Circulation | Novosibirsk | Novosibirskaya Obl |
Lead Sponsor | Collaborator |
---|---|
Meshalkin Research Institute of Pathology of Circulation |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of the procedure | freedom from thrombosis was defined as the absence of occlusion by duplex ultrasonography or CT angiography of the treated segment | 24 months | |
Primary | Safety of the procedure | bleeding according to blood loss volume (millilitres) 1. intraoperative blood loss volume; 2.Postoperative blood loss volume by duplex ultrasonography and drainage losses | 30 days | |
Primary | Safety of the procedure | major adverse limb events according to clinical evaluation | 24 months | |
Secondary | Primary patency | Primary patency rate at 24 months follow-up | 24 months | |
Secondary | Secondary patency | Secondary patency rate at 24 months follow-up | 24 months | |
Secondary | Changes in the patients quality of life: questionnaire | improving the quality of life in accordance with the questionnaire "The Short Form-36" for 24 months. The indicators of each scale are designed in such a way that the higher the value of the indicator (from 0 to 100), the better the score on the selected scale | 24 months | |
Secondary | Success of the procedure | the number of successful attempts | 1 month | |
Secondary | Changes in chronic lower limb ischemia at 24 months follow-up | Number of cases of improvement of at least 1 category of Rutherford classification for claudicants | 24 months |
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