NCT06297343

Study of the Risk of Ischaemia Following the Creation of an Arteriovenous Fistula

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 544 (estimated)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-20
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-03-07
• Last updated: 2025-11-24

Locations

1 site across 1 country: France