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
Atherosclerotic Ischemic Disease, Critical Limb Ischemia, Superficial Femoral Artery Occlusion
About this trial
This is an interventional treatment trial for Atherosclerotic Ischemic Disease focused on measuring intervowen biomimetic nitinol stent, TASC D, femoro-popliteal distal bypass, Critical limb ischemia
Eligibility Criteria
Inclusion Criteria:
- Adults patients (>18 years old);
- Critical limb ischemia (4-6 Rutherford category);
- Atherosclerotic occlusive lesion of the arteries of the femoropopliteal segment below the knee joint, classified by TASC II as type D, confirmed by computed tomography or arteriography;
- De Novo lession;
- Patient consent;
- Lack of suitable autologous shunting material (GSV)
Exclusion Criteria:
- Juvenile patient (< 18 years old);
- Pregnancy;
- Asymptomatic lession;
- Acute ischemia;
- Previous treatment on the target lession;
- Non-atherosclerotic lession;
- Severe comorbidity with a life expectancy - less than 2 years;
- Contraindications to antiplatelet therapy;
- Patient participation in another clinical trial;
- Patient refusal to participate in the study;
- Availability of suitable autologous bypass material.
Sites / Locations
- Meshalkin National Medical Research Center Ministry of healthcare of RussiaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Endovascular recanalization
Open surgery
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. n=45
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. n=45