NCT05455138

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

4 years

First QC Date

July 4, 2022

Last Update Submit

November 15, 2023

Conditions

Critical Lower Limb Ischemia

Keywords

Critical Lower Limb Ischemiaatherosclerosisperipheral arterial disease

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with lethal outcomes

    The primary outcome measure is mortality rate

    24 months

Secondary Outcomes (4)

  • Number of Participants with Graft thrombosis

    24 months

  • Myocardial infarction

    1, 3, 6, 12, 18, and 24 months

  • Number of Participants with Acute coronary syndrome

    24 months

  • Number of Participants with Stroke or transient ischemic attack

    24 months

Study Arms (4)

Arterial bypass procedures using autologous venous graft

EXPERIMENTAL

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 procedures using allogeneic venous graft

EXPERIMENTAL

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 procedures using allogeneic arterial graft

EXPERIMENTAL

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 procedures using biologic bovine decellularized arterial graft

EXPERIMENTAL

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

Interventions

Arterial bypass graftingPROCEDURE

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

Arterial bypass procedures using allogeneic arterial graftArterial bypass procedures using allogeneic venous graftArterial bypass procedures using autologous venous graftArterial bypass procedures using biologic bovine decellularized arterial graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • males or females over 18 years of age;
  • critical lower limb ischemia due to atherosclerotic peripheral arterial disease.

You may not qualify if:

  • males or females less than 18 year of age;
  • decompensated concomitant pathology;
  • pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryazan State Medical University

Ryazan, 390026, Russia

RECRUITING

MeSH Terms

Conditions

AtherosclerosisPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Igor Suchkov, PhD, DMedSc

    Ryazan State Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Igor Suchkov, PhD, DMedSc

CONTACT

+7 (4912) 97-18-01suchkov_med@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 13, 2022

Study Start

December 1, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)