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Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05545267
Acronym
SAVE
Enrollment
144
Registered
2022-09-19
Start date
2021-09-17
Completion date
2022-10-31
Last updated
2022-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arteriovenous Fistula Stenosis

Keywords

blood vessel repair, arteriovenous fistula, ultrasound angioplasty

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.

Interventions

PROCEDUREAngioplasties

Transluminal angioplastie

Sponsors

Centre Hospitalier de Vichy
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
morbidity and mortalityduring interventionThe primary outcome measure to evaluate morbidity and mortality will be the number of acute complications that occurred during the procedure and by type of complication (wall hematoma, thrombosis, rupture, spasm, injection site hematoma, pseudoaneurysm, failure)

Secondary

MeasureTime frameDescription
Stenosis diameterpre-intervention, immediately after the intervention, 1 monthVariation of the stenosis diameter
Endoluminal reference diameterpre-intervention, immediately after the intervention, 1 monthVariation of the endoluminal diameter
Maximum systolic velocity (VSmax)pre-intervention, immediately after the intervention, 1 monthVariation of the maximum systolic velocity
Ratio of VSmax to upstreampre-intervention, immediately after the intervention, 1 monthVaration of Ratio of VSmax to upstream
End-diastolic velocitypre-intervention, immediately after the intervention, 1 monthVariation of end-diastolic velocity
Post-angioplasty permeability2 yearsPost-angioplasty primary permeability, and post-angioplasty primary assisted permeability and post-angioplasty secondary permeability over the entire follow-up period
Brachial artery Maximum flowpre-intervention, immediately after the intervention, 1 monthVariation of brachial artery maximum flow
Brachial artery end-diastolic velocity (EDV)pre-intervention, immediately after the intervention, 1 monthVaraition of Brachial artery end-diastolic velocity
Brachial artery maximum systolic velocitypre-intervention, immediately after the intervention, 1 monthVariation of brachial artery maximum systolic velocity
Brachial artery Resistance Indexpre-intervention, immediately after the intervention, 1 monthVariation of brachial artery Resistance Index
Diameter of the anastomosispre-intervention, immediately after the intervention, 1 monthVariation of anastomosis diameter

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026