Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C (ERAV)
NCT ID: NCT05101512
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
150 participants
INTERVENTIONAL
2020-07-15
2024-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Questionnaires on quality of life after surgery
Patient has to answer different questionnaire about quality of life, pain, functional scores
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Questionnaires on quality of life after surgery
Patient has to answer different questionnaire about quality of life, pain, functional scores
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Clinical Trial Experts Network
OTHER
Private Hospital Dijon
UNKNOWN
Ramsay Générale de Santé
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Private Hospital of Dijon
Dijon, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jea-Luc Pin, Dr
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-A02444-51
Identifier Type: -
Identifier Source: org_study_id