Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula (MODIFVASC)

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Failure
• Intervention / Treatment: Procedure: Creation of an arteriovenous fistula

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 Type: Observational
• Enrollment (Estimated): 544

Contacts and Locations

• Study Contact: Name: Viviane DUEDAL, MD; Phone Number: +33 6 70 80 18 98; Email: v.duedal@gmail.com

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Hopital Prive des Peupliers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be adult patients suffering from chronic renal failure for whom the creation of an arteriovenous fistula is planned.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult patients with chronic renal failure; Adult patients with chronic renal failure for whom arteriovenous fistula creation is planned

Procedure: Creation of an arteriovenous fistula; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency
• Other Study ID Numbers: 2023-A02491-44

Drug and device information, study documents

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