Study of the AFB and Stenting of the Iliac Arteries

Study Overview
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Brief Summary
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The aim of the study is to compare effectiveness and long-term results of aorta-femoral reconstructions and endovascular treatment in the patients with aorta-iliac lesions (TASC C,D).

Official Title
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Prospective Randomized Clinical Study of the Aorto-femoral Bypass and the Iliac Arteries With Stenting Recanalization Effectiveness in Patients With the Iliac Segment Occlusive Disease

Conditions
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Aorta-iliac Segment Lesion (C,D Type by TASC II)

Intervention / Treatment
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* Procedure: Aorta-femoral bypass
* Procedure: Recanalization and stenting of aorta-iliac segment
* Drug: Therapy: aspirin and clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with occlusive lesions of C and D type iliac segment, and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford), age: 47-75 years old. Patients who consented to participate in this study. Exclusion Criteria: Chronic heart failure of III-IV functional class by NYHA classification. Decompensated chronic pulmonary heart Severe hepatic or renal failure (bilirubin> 35 mmol / l, glomerular filtration rate <60 mL / min); Polyvalent drug allergy Cancer in the terminal stage with a life expectancy less than 6 months; Acute ischemic Expressed aortic calcification tolerant to angioplasty Patients with significant common femoral artery lesion Patient refusal to participate or continue to participate in the study

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Operations technique on the abdominal aorta. Aorta-femoral bypass. Medication: after surgery all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily). | Procedure: Aorta-femoral bypass<br>* Access to the femoral artery is performed through a lateral incision from the inguinal ligament. Operations technique on the abdominal aorta. Aorta-femoral bypass. Proximal anastomosis between the prosthesis and aorta is applied in the sort of end-to-side in the reconstruction by shunting. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. In a case of preserved antegrade blood flow the femoral artery anastomosis applied in the sort of end-to-side. If antegrade flow is absent, anastomosis is formed in the sort of end to end.<br>Drug: Therapy: aspirin and clopidogrel<br>* prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).<br>|
| Active Comparator: Group 2<br>Standard endovascular treatment (stenting) in patients with the iliac segment occlusive disease. Medication: after stenting all patients are prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily). | Procedure: Recanalization and stenting of aorta-iliac segment<br>* Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized. Stenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often mixed) artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter).<br>Drug: Therapy: aspirin and clopidogrel<br>* prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary composite endpoint (efficacy): primary patency, secondary patency | If a damage confirmed by duplex is detected, repeat intervention is performed on the side of the examined segment. The physiological parameter and questionnaire will be used. | 30 days | 
| success of the procedure | Technical ability to perform the surgical intervention | 30 days | 
| safeness: clinically significant bleeding, hematoma, infection of the prosthesis, infection of postoperative wound, lymphorrhea, renal failure, myocardial infarction, stroke, mortality, thrombosis of the operated segment, distal embolism | Identification of serious adverse events requiring correction of therapy or surgery. Will be used physiological parameter and questionnaire. Classification of bleeding will be used GUSTO (Severe or moderate) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality in the long-term postoperative period |  | 3 years | 
| stroke in the remote postoperative period |  | 3 years | 
| myocardial infarction in the remote postoperative period |  | 3 years | 
| preservation of limb in the long-term postoperative period |  | 3 years |