Clinical trial NCT05545267: Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler
Official title: Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler (SAVE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arteriovenous Fistula Stenosis
Keywords: blood vessel repair
arteriovenous fistula
ultrasound angioplasty
Lead sponsor: Centre Hospitalier de Vichy
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with end-stage renal disease treated by dialysis whose AVF angioplasties is performed under echo-doppler at the Vcihy Hospital Center

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Patient undergoing whose fistula is treated by angioplasty under echo-doplerat the Vichy Hospital Center between 01/01/2015 and 31/12/2019

Exclusion Criteria:

* Patients who are minors,
* Patients with an AVF with a flow rate \< 100 mL/min.
* Patients with acute or chronic, segmental or total occlusion of an AVF segment
* Patients with acute or chronic, segmental or total thrombosis of an AVF segment
* Patients whose main obstacle is located on the arterial side.
* Intervention that required the use of X-rays.

Primary outcomes:
measure: morbidity and mortality
timeFrame: during intervention
Secondary outcomes:
measure: Post-angioplasty permeability
timeFrame: 2 years
measure: Stenosis diameter
timeFrame: pre-intervention, immediately after the intervention, 1 month
measure: Endoluminal reference diameter
timeFrame: pre-intervention, immediately after the intervention, 1 month
measure: Maximum systolic velocity (VSmax)
timeFrame: pre-intervention, immediately after the intervention, 1 month
measure: Ratio of VSmax to upstream
timeFrame: pre-intervention, immediately after the intervention, 1 month
measure: End-diastolic velocity
timeFrame: pre-intervention, immediately after the intervention, 1 month
measure: Diameter of the anastomosis
timeFrame: pre-intervention, immediately after the intervention, 1 month
measure: Brachial artery Maximum flow
timeFrame: pre-intervention, immediately after the intervention, 1 month
measure: Brachial artery end-diastolic velocity (EDV)
timeFrame: pre-intervention, immediately after the intervention, 1 month
measure: Brachial artery maximum systolic velocity
timeFrame: pre-intervention, immediately after the intervention, 1 month
measure: Brachial artery Resistance Index
timeFrame: pre-intervention, immediately after the intervention, 1 month
Other outcomes:
Locations:
city: Vichy
country: France
facility: Centre Hospitalier de Vichy (CHV)
Study officials:
affiliation: Centre hopsitalier de Vichy
name: Fabrice ABBADIE
role: STUDY_DIRECTOR
References: