Allografts in Surgery of the Main Arteries

Study Overview
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Brief Summary
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The study will examine the results of the use of biological materials (allogeneic arterial grafts, allogeneic venous graft, autologous vein, biological bovine decellularized graft) as a bypass grafts for reconstructive interventions in patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease in the short-term and long-term postoperative periods. Histological analysis of allogeneic grafts will be carried out at various time points of graft preservation with a Roswell Park Memorial Institute 1640 cell medicum with 400mcg/ml gentamicin and 20mcg/ml fluconazole at a temperature of +4C. The physical properties of allogeneic grafts from postmortem donors (tensile and tear strength) will be evaluated at various conservation time periods (1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks). Markers of endothelial dysfunction (IL-6, endothelin-1, 6-keto-prostaglandin F1alfa, eNOS) will be evaluated in patients with critical ischemia who undergo bypass procedures with arterial and venous allografts at various time points (before surgery, 7 days, 1 month, 3 months, 6 months, 1 year after).

Detailed Description
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The study will include 200 patients of similar age, gender, and ethnicity, who will be divided into four groups: Group I: 50 patients who undergo arterial bypass procedures using autologous venous graft derived from great saphenous vein; Group II: 50 patients who undergo arterial bypass procedures using allogeneic venous grafts; Group III: 50 patients who undergo arterial bypass procedures using allogeneic arterial grafts; Group IV: 50 patients using biological bovine decellularized grafts. Patients will be monitored for 2 years: at inclusion, and 1, 3, 6, 12, 18, and 24 months after bypass procedures. The primary endpoint of the study will be mortality, i.e. death of the patient from any cause. Secondary endpoints of the study will be graft thrombosis and cardiovascular events such as myocardial infarction, acute coronary syndrome, transient ischemic attack, and stroke.

Official Title
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Allografts in Surgery of the Main Arteries

Conditions
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Critical Lower Limb Ischemia

Intervention / Treatment
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* Procedure: Arterial bypass grafting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males or females over 18 years of age; critical lower limb ischemia due to atherosclerotic peripheral arterial disease. Exclusion Criteria: males or females less than 18 year of age; decompensated concomitant pathology; pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arterial bypass procedures using autologous venous graft<br>Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using autologous venous graft | Procedure: Arterial bypass grafting<br>* Arterial bypass grafting in patients with critical limb ischemia due to peripheral artery disease<br>|
| Experimental: Arterial bypass procedures using allogeneic venous graft<br>Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using allogeneic venous graft | Procedure: Arterial bypass grafting<br>* Arterial bypass grafting in patients with critical limb ischemia due to peripheral artery disease<br>|
| Experimental: Arterial bypass procedures using allogeneic arterial graft<br>Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using allogeneic arterial graft | Procedure: Arterial bypass grafting<br>* Arterial bypass grafting in patients with critical limb ischemia due to peripheral artery disease<br>|
| Experimental: Arterial bypass procedures using biologic bovine decellularized arterial graft<br>Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using biologic bovine decellularized arterial graft | Procedure: Arterial bypass grafting<br>* Arterial bypass grafting in patients with critical limb ischemia due to peripheral artery disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with lethal outcomes | The primary outcome measure is mortality rate | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Graft thrombosis | The secondary outcome measure is graft thrombosis | 24 months | 
| Myocardial infarction | The secondary outcome measure is myocardial infarction | 1, 3, 6, 12, 18, and 24 months | 
| Number of Participants with Acute coronary syndrome | The secondary outcome measure is acute coronary syndrome | 24 months | 
| Number of Participants with Stroke or transient ischemic attack | The secondary outcome measure is stroke or transient ischemic attack | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical Lower Limb Ischemia, atherosclerosis, peripheral arterial disease