Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C (ERAV) (ERAV)

Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C.

The main objective of this study is to assess the 2-year survival with salvage of the lower limb of patients who have undergone subgonal bypass grafting by venous allograft in the treatment of Occlusive Peripheral Arterial Disease (OPAD) in critical ischemia, in the absence of usable great saphenous vein.

Study Overview

• Status: Recruiting
• Conditions: Venous Allogeneic Transplant; Occlusive Peripheral Arterial Disease
• Intervention / Treatment: Behavioral: Questionnaires on quality of life after surgery

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • Private Hospital of Dijon
    • Contact: Jea-Luc Pin, Dr; Phone Number: 06 77 14 84 45; Email: jeanlucpin@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Man or woman over 18 (under effective contraception, hormonal contraceptive or intrauterine device, if premenopausal).
• Patient with critical ischemia of the lower limb (stage 4-5-6 according to the Rutherford classification) requiring revascularization by sub-gonal bypass
• Patient eligible and scheduled for bypass in venous allograft stored at + 4 ° C with distal anastomosis below the knee
• Patient without usable autologous great Saphenous vein
• Subject affiliated or beneficiary of a social security scheme
• Patient having received the appropriate information concerning the objectives and procedures of the study and having declared his non-objection.

Exclusion Criteria:

• Use of unscheduled allografts
• Patient requiring composite bypass in AGV + autologous venous material or prosthesis
• Patient requiring replacement of infected prostheses
• Patient with acute ischemia
• Patient with severe coagulation disorders
• Patient classified physical status score 4
• Patient participating in another clinical trial
• Potential allergy to the graft
• Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision
• Pregnant or breastfeeding woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with critical ischemia of the lower limb; Patient eligible and scheduled for bypass in venous allograft stored at + 4 ° C with distal anastomosis below the knee	Behavioral: Questionnaires on quality of life after surgery; Patient has to answer different questionnaire about quality of life, pain, functional scores

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate of patients at 2 years with lower limb rescue	survival rate of patients at 2 years with lower limb rescue (time until death or amputation - amputation free survival)	2 years

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: European Clinical Trial Experts Network; Private Hospital Dijon

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): January 15, 2024

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 2018-A02444-51

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No