Allografts in Surgery of the Main Arteries

November 15, 2023 updated by: Ryazan State Medical University

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Ryazan, Russian Federation, 390026
        • Recruiting
        • Ryazan State Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Procedure: Arterial bypass grafting
Arterial bypass grafting in patients with critical limb ischemia due to peripheral artery disease
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
Procedure: Arterial bypass grafting
Arterial bypass grafting in patients with critical limb ischemia due to peripheral artery disease
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
Procedure: Arterial bypass grafting
Arterial bypass grafting in patients with critical limb ischemia due to peripheral artery disease
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
Procedure: Arterial bypass grafting
Arterial bypass grafting in patients with critical limb ischemia due to peripheral artery disease

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryazan State Medical University

Investigators

  • Principal Investigator: Igor Suchkov, PhD, DMedSc, Ryazan State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

July 4, 2022

First Submitted That Met QC Criteria

July 8, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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