Renal FailureMODIFVASCNCT06297343
Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula
An observational study of Renal Failure, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure
- What is being tested?
- Creation of an arteriovenous fistula
- Type of treatment
- Surgery or procedure
- How many people
- 544 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population will be adult patients suffering from chronic renal failure for whom the creation of an arteriovenous fistula is planned.
Who may be able to join
- Age ≥ 18 years;
- Stage 5 chronic kidney disease, on dialysis or not on dialysis;
- Requiring the creation of an arteriovenous fistula;
- Membership of a social insurance scheme;
- Patient having been informed and having formulated his/her oral non-opposition to participate in the research.
Who cannot join
- Contraindication to the proposed surgery ;
- Reduced life expectancy in the opinion of the investigator;
- Medical or biological conditions which, in the opinion of the investigator, could influence the interpretation of the results of the study or the safety of the patient;
- Patient uncooperative with protocol requirements or unable to attend scheduled visits to the centre;
- Other surgical or medical intervention planned during the study;
- Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
- Participating in another clinical trial, or in a period of exclusion from another clinical trial;
- Patient under guardianship or deprived of liberty.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation.
Read the detailed description
This is a non-interventional, prospective, non-randomised, descriptive, single-centre study with no comparator.
The study population will be adult patients with chronic renal failure for whom an arteriovenous fistula has been planned.
Patients requiring the creation of an arteriovenous fistula by the surgeons at Hôpital Privé des Peupliers will be seen beforehand in the usual pre-operative consultation, during which the surgeon will explain the principle of the operation and the expected benefits/risks. On the day of surgery, patients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day. Patients will be reviewed during post-operative follow-up visits at 1, 6 and 12 months as in standard practice. All the data collected in the study were collected in routine medical practice.
- Conditions
- Renal Failure
- Being tested
- Creation of an arteriovenous fistula
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creation of an arteriovenous fistulaProcedure or surgery
Patients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day (outpatient care, or an overnight stay in hospital if they live a long way from the hospital, have multiple pathologies or are socially isolated). An arteriovenous fistula is created under local or general anaesthetic. On the day of the operation, the type of arteriovenous fistula created, the side of the arteriovenous fistula, the location of the arteriovenous fistula and the patency of the arteriovenous fistula will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with chronic renal failure | Adult patients with chronic renal failure for whom arteriovenous fistula creation is planned Receives: Procedure: Creation of an arteriovenous fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of ischaemia of the hand
Number and proportion of patients with ischaemia (Yes = stages 1, 2 or 3/No = stage 0) according to the preoperative American Vascular Surgery ischaemia classification :
0 - nothing
- - cold hand
- - pain on exercise and/or during dialysis
- - permanent pain, wound (ulceration, necrosis, gangrene)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start20 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297343
- Sponsor's protocol ID
- 2023-A02491-44
- Acronym
- MODIFVASC
- Status last verified
- Nov 2025
- First submitted
- 29 Feb 2024
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula
- ClinicalTrials.gov ID
- NCT06297343
- Acronym / sponsor ID
- MODIFVASC / 2023-A02491-44
- Conditions
- Renal Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Mar 2024 (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 purpose of this study is to identify functional vascular changes and clinical factors correlated with the occurrence of short- or medium-term hand ischaemia after arteriovenous fistula creation.
Detailed description
This is a non-interventional, prospective, non-randomised, descriptive, single-centre study with no comparator.
The study population will be adult patients with chronic renal failure for whom an arteriovenous fistula has been planned.
Patients requiring the creation of an arteriovenous fistula by the surgeons at Hôpital Privé des Peupliers will be seen beforehand in the usual pre-operative consultation, during which the surgeon will explain the principle of the operation and the expected benefits/risks. On the day of surgery, patients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day. Patients will be reviewed during post-operative follow-up visits at 1, 6 and 12 months as in standard practice. All the data collected in the study were collected in routine medical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with chronic renal failure | – | Procedure: Creation of an arteriovenous fistulaAdult patients with chronic renal failure for whom arteriovenous fistula creation is planned |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be adult patients suffering from chronic renal failure for whom the creation of an arteriovenous fistula is planned.
Key inclusion criteria (5 listed)
- Age ≥ 18 years;
- Stage 5 chronic kidney disease, on dialysis or not on dialysis;
- Requiring the creation of an arteriovenous fistula;
- Membership of a social insurance scheme;
- Patient having been informed and having formulated his/her oral non-opposition to participate in the research.
Key exclusion criteria (8 listed)
- Contraindication to the proposed surgery ;
- Reduced life expectancy in the opinion of the investigator;
- Medical or biological conditions which, in the opinion of the investigator, could influence the interpretation of the results of the study or the safety of the patient;
- Patient uncooperative with protocol requirements or unable to attend scheduled visits to the centre;
- Other surgical or medical intervention planned during the study;
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 |
|---|---|---|
| Creation of an arteriovenous fistulaPatients will undergo the surgical procedure to create an arteriovenous fistula and will be discharged the same day (outpatient care, or an overnight stay in hospital if they live a long way from the hospital, have multiple pathologies or are socially isolated). An arteriovenous fistula is created under local or general anaesthetic. On the day of the operation, the type of arteriovenous fistula created, the side of the arteriovenous fistula, the location of the arteriovenous fistula and the patency of the arteriovenous fistula will be collected. | Procedure or surgery | Adult patients with chronic renal failure |
Primary outcome
Occurrence of ischaemia of the hand
Time frame: 12 months
Number and proportion of patients with ischaemia (Yes = stages 1, 2 or 3/No = stage 0) according to the preoperative American Vascular Surgery ischaemia classification : 0 - nothing 1. - cold hand 2. - pain on exercise and/or during dialysis 3. - permanent pain, wound (ulceration, necrosis, gangrene)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure, 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viviane DUEDAL, MD (6 70 80 18 98 ext. +33, v.duedal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of ischaemia of the hand (time frame: 12 months). 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 24 Nov 2025.