Venous Allogeneic TransplantERAVNCT05101512
Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C (ERAV)
A study testing Questionnaires on quality of life after surgery in people with Venous Allogeneic Transplant and Occlusive Peripheral Arterial Disease, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Allogeneic Transplant, Occlusive Peripheral Arterial Disease
- What is being tested?
- Questionnaires on quality of life after surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2020to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Private Hospital of Dijon
Dijon, 21000
Jea-Luc Pin, Dr, 06 77 14 84 45, jeanlucpin@yahoo.com
About this study
Official title: 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.
- Being tested
- Questionnaires on quality of life after surgery
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaires on quality of life after surgeryBehavioural
Patient has to answer different questionnaire about quality of life, pain, functional scores
| Study group | Role | What they receive |
|---|---|---|
| Patient with critical ischemia of the lower limb | Experimental | Patient eligible and scheduled for bypass in venous allograft stored at + 4 ° C with distal anastomosis below the knee Receives: Behavioral: Questionnaires on quality of life after surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start15 Jul 2020
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Allogeneic TransplantStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Private Hospital Dijon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101512
- Sponsor's protocol ID
- 2018-A02444-51
- Acronym
- ERAV
- Status last verified
- Oct 2021
- First submitted
- 28 Oct 2021
- Last updated
- 1 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Sub-gonal Arterial Revascularization of the Lower Limbs in Critical Ischemia by Venous Allograft Stored at + 4 ° C.
- ClinicalTrials.gov ID
- NCT05101512
- Acronym / sponsor ID
- ERAV / 2018-A02444-51
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network, Private Hospital Dijon
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with critical ischemia of the lower limb | Experimental | Behavioral: Questionnaires on quality of life after surgeryPatient eligible and scheduled for bypass in venous allograft stored at + 4 ° C with distal anastomosis below the knee |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires on quality of life after surgeryPatient has to answer different questionnaire about quality of life, pain, functional scores | Behavioural | Patient with critical ischemia of the lower limb |
Primary outcome
Survival rate of patients at 2 years with lower limb rescue
Time frame: 2 years
survival rate of patients at 2 years with lower limb rescue (time until death or amputation - amputation free survival)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires on quality of life after surgery in people with Venous Allogeneic Transplant and Occlusive Peripheral Arterial Disease, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate of patients at 2 years with lower limb rescue (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.