Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler

Active, not recruiting

• Conditions: Arteriovenous Fistula Stenosis

• Registration Number: NCT05545267
• Lead Sponsor: Centre Hospitalier de Vichy

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.

Study Timeline

• Study Start: 2021-09-17
• Primary Completion: 2021-12-12
• Status Verified: 2022-09
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-14
• Last Update Submitted: 2022-09-14
• Study First Posted: 2022-09-19
• Last Update Posted: 2022-09-19
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 144

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
morbidity and mortality	during intervention	The 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 Outcome Measures

Name	Time	Method
Post-angioplasty permeability	2 years	Post-angioplasty primary permeability, and post-angioplasty primary assisted permeability and post-angioplasty secondary permeability over the entire follow-up period
Endoluminal reference diameter	pre-intervention, immediately after the intervention, 1 month	Variation of the endoluminal diameter
Maximum systolic velocity (VSmax)	pre-intervention, immediately after the intervention, 1 month	Variation of the maximum systolic velocity
Ratio of VSmax to upstream	pre-intervention, immediately after the intervention, 1 month	Varation of Ratio of VSmax to upstream
Diameter of the anastomosis	pre-intervention, immediately after the intervention, 1 month	Variation of anastomosis diameter
Brachial artery Resistance Index	pre-intervention, immediately after the intervention, 1 month	Variation of brachial artery Resistance Index
End-diastolic velocity	pre-intervention, immediately after the intervention, 1 month	Variation of end-diastolic velocity
Brachial artery Maximum flow	pre-intervention, immediately after the intervention, 1 month	Variation of brachial artery maximum flow
Brachial artery end-diastolic velocity (EDV)	pre-intervention, immediately after the intervention, 1 month	Varaition of Brachial artery end-diastolic velocity
Stenosis diameter	pre-intervention, immediately after the intervention, 1 month	Variation of the stenosis diameter
Brachial artery maximum systolic velocity	pre-intervention, immediately after the intervention, 1 month	Variation of brachial artery maximum systolic velocity

Trial Locations

Locations (1)

Centre Hospitalier de Vichy (CHV); 🇫🇷 Vichy, France