Endovascular treatment for multilevel artery blockages

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

This study is testing a new less invasive treatment for patients with severe leg artery blockages to see if it can improve their blood flow and quality of life better than traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 45 Years to 80 Years
• Sex: All
• Sponsor: Meshalkin Research Institute of Pathology of Circulation (Research network)
• Locations: 1 site (Novosibirsk, Novosibirskaya Obl)
• Trial ID: NCT04461496 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of total endovascular revascularization for patients with multilevel lesions in the iliac-femoral-popliteal segment, comparing it to traditional hybrid interventions. The goal is to determine if this less invasive approach can improve patient outcomes and quality of life by minimizing skin damage and postoperative complications. The study focuses on patients suffering from critical limb ischemia due to atherosclerosis, aiming to enhance blood flow and reduce the need for more invasive surgical procedures. Participants will be monitored for improvements in symptoms and overall limb health.

Who should consider this trial

Good fit: Ideal candidates include patients with multisegment lesions of the iliac-femoral-popliteal segment experiencing chronic ischemia.

Not a fit: Patients with chronic occlusions of the superficial femoral artery or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer and more effective treatment options for patients with complex arterial blockages.

How similar studies have performed: While the concept of endovascular revascularization is established, this specific approach is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

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.

Where this trial is running

Novosibirsk, Novosibirskaya Obl

• Meshalkin Research Institute of Pathology of Circulation — Novosibirsk, Novosibirskaya Obl, Russian Federation (Recruiting)

Study contacts

• Study coordinator: Andrey A Karpenko, PHD

Conditions Superficial Femoral Artery Stenosis; Iliac Artery Occlusion; hybrid revascularization; atherosclerosis