Allografts in Surgery of the Main Arteries

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• males or females over 18 years of age;

• critical lower limb ischemia due to atherosclerotic peripheral arterial disease.

Locations
Other Locations
Russian Federation
Ryazan State Medical University
RECRUITING
Ryazan
Contact Information
Primary
Igor Suchkov, PhD, DMedSc
suchkov_med@mail.ru
+7 (4912) 97-18-01
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 200
Treatments
Experimental: Arterial bypass procedures using autologous venous graft
Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using autologous venous graft
Experimental: Arterial bypass procedures using allogeneic venous graft
Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using allogeneic venous graft
Experimental: Arterial bypass procedures using allogeneic arterial graft
Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using allogeneic arterial graft
Experimental: Arterial bypass procedures using biologic bovine decellularized arterial graft
Patients with critical lower limb ischemia due to atherosclerotic peripheral arterial disease who undergo arterial bypass procedures using biologic bovine decellularized arterial graft
Sponsors
Leads: Ryazan State Medical University

This content was sourced from clinicaltrials.gov

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