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

Primary Purpose

Venous Allogeneic Transplant, Occlusive Peripheral Arterial Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires on quality of life after surgery
Sponsored by
Ramsay Générale de Santé
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Allogeneic Transplant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Private Hospital of DijonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient with critical ischemia of the lower limb

Arm Description

Patient eligible and scheduled for bypass in venous allograft stored at + 4 ° C with distal anastomosis below the knee

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
October 28, 2021
Last Updated
October 28, 2021
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network, Private Hospital Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT05101512
Brief Title
Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C (ERAV)
Acronym
ERAV
Official Title
Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network, Private Hospital Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Allogeneic Transplant, Occlusive Peripheral Arterial Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with critical ischemia of the lower limb
Arm Type
Experimental
Arm Description
Patient eligible and scheduled for bypass in venous allograft stored at + 4 ° C with distal anastomosis below the knee
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires on quality of life after surgery
Intervention Description
Patient has to answer different questionnaire about quality of life, pain, functional scores
Primary Outcome Measure Information:
Title
Survival rate of patients at 2 years with lower limb rescue
Description
survival rate of patients at 2 years with lower limb rescue (time until death or amputation - amputation free survival)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Private Hospital of Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jea-Luc Pin, Dr
Phone
06 77 14 84 45
Email
jeanlucpin@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

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

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