Allografts in Surgery of the Main Arteries

Critical Lower Limb Ischemia Clinical Trial

Official title:

Allografts in Surgery of the Main Arteries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455138
• Other study ID #: 4
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: November 2023
• Source: Ryazan State Medical University
• Contact: Igor Suchkov, PhD, DMedSc
• Phone: +7 (4912) 97-18-01
• Email: suchkov_med[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Lower Limb Ischemia
• Ischemia

Intervention

Procedure:
• Arterial bypass grafting
Arterial bypass grafting in patients with critical limb ischemia due to peripheral artery disease

Locations

Country	Name	City	State
Russian Federation	Ryazan State Medical University	Ryazan

Sponsors (1)

Lead Sponsor	Collaborator
Ryazan State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with lethal outcomes	The primary outcome measure is mortality rate	24 months
Secondary	Number of Participants with Graft thrombosis	The secondary outcome measure is graft thrombosis	24 months
Secondary	Myocardial infarction	The secondary outcome measure is myocardial infarction	1, 3, 6, 12, 18, and 24 months
Secondary	Number of Participants with Acute coronary syndrome	The secondary outcome measure is acute coronary syndrome	24 months
Secondary	Number of Participants with Stroke or transient ischemic attack	The secondary outcome measure is stroke or transient ischemic attack	24 months