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Efficacy and Safety Comparison of the Open and Endovascular Surgical Methods for the Treatment of Long Atherosclerotic Lesions of the Femoral-popliteal Segment Below the Knee, TASC D in Patients With Critical Limb Ischemia

NCT04583436 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-10-12

No results posted yet for this study

Summary

This is prospective, randomized study. The main objective of the study is to compare the clinical efficacy and safety of two therapies for the treatment of prolonged atherosclerotic lesions of the arteries of the femoropopliteal segment below the knee, TASC II type D - femoropopliteal distal bypass with a synthetic ePTDE-grafts and recanalization with angioplasty and stenting using a biomimetic intervowen nitinol stent in patients with symptomatic peripheral arterial disease after 24 months. Secondary objectives are to identify predictors of restenosis and occlusions of the operated segment and compare the quality of life of patients after the procedure.

Conditions

  • Atherosclerotic Ischemic Disease
  • Critical Limb Ischemia
  • Superficial Femoral Artery Occlusion
  • Popliteal Artery Occlusion

Interventions

DEVICE

Endovascular recanalization

Recanalization with angioplasty and stenting: Under local anesthesia, a standard endovascular approach is performed and the affected arterial segment is visualized. Perform transluminal or subintimal recanalization of the occluded segment of the arteries with a hydrophilic guide wire. Next, balloon angoplasty of the recanalized segment is performed. After control angiography, a biomimetic braided nitinol stent is placed throughout the lesion.

OTHER

Open surgery

Femoropopliteal distal bypass with a synthetic ePTFE graft: Under general anesthesia, 2 standard open surgical approaches are performed: one to the common femoral artery, superficial femoral artery and deep femoral artery; the second - to the third portion of the popliteal artery, the tibioperoneal trunk and the anterior tibial artery. After systemic heparinization, clamps are applied to the arteries. A longitudinal arteriotomy of the popliteal artery is performed, and a distal end-to-side anastomosis is formed between the artery and the graft. Next, the graft is passed into the groin wound. Longitudinal arteriotomy of the common femoral artery. A proximal end-to-side anastomosis is formed between the shunt and the common femoral artery. Clamps are removed from arteries, blood flow is started, surgical hemostasis, wound drainage, layer-by-layer wound closure is performed.

Sponsors & Collaborators

  • Meshalkin Research Institute of Pathology of Circulation

    lead NETWORK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2024-09-01
Completion
2024-10-01

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04583436 on ClinicalTrials.gov