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UnknownNCT05545267

Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler

Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler (SAVE)

Status
Unknown
Phase
Study type
Observational
Enrollment
144 (actual)
Sponsor
Centre Hospitalier de Vichy · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Dialysis vascular accesses called arteriovenous fistulas ( AVF) are essential to ensure extra-renal purification by hemodialysis for patients with chronic end-stage renal disease. Complications of dialysis AVF cause significant morbidity and hospitalization. Dialysis AVF angioplasties are frequently used to treat stenosis, the 1st complication concerning them and which announces the complete thrombosis which may be the definitive loss of the AVF. Historically performed under X-ray, the progression in the quality of ultrasound scanners allows today to perform this procedure under echo-Doppler guidance and thus to avoid both radiation and the injection of iodinated contrast products and their complications. It is thus possible to preserve residual renal function, a situation with a better prognosis, or to help the maturation of the AVF without precipitating the patient towards dialysis. The procedure can then be less costly, requiring a much lighter infrastructure. The complication rates of ultrasound angioplasty remain poorly known because only a few series have been published. In addition, the evolution of the echo-Doppler parameters of the AVF is unknown during angioplasty and it is difficult to know which are the most reliable to distinguish during the procedure a "good angioplasty gesture" from an incomplete angioplasty to be continued. The proposed study would provide initial insight into the question posed.

Detailed description

This is an observational, retrospective study on data from routine care. All angioplasties concerning major patients, meeting the inclusion criteria and performed during the inclusion period will be taken into account. (For this purpose, a list of procedures performed at the Vichy Hospital will be established via the angioplasty procedure reports. In order to establish the evolution of the echographic parameters over time, the echographic data will also be collected from each follow-up report corresponding to each procedure until the end of the follow-up. These reports correspond to the normal post-intervention control ultrasounds at 1 month, 3 months and the annual visits. If intermediate ultrasounds are available, their reports will also be used. In the case of a patient having an emergency angioplasty, the data of the control ultrasound triggering the intervention will be used as pre-intervention data.

Conditions

Interventions

TypeNameDescription
PROCEDUREAngioplastiesTransluminal angioplastie

Timeline

Start date
2021-09-17
Primary completion
2021-12-12
Completion
2022-10-31
First posted
2022-09-19
Last updated
2022-09-19

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05545267. Inclusion in this directory is not an endorsement.