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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arteriovenous Fistula Stenosis
• Intervention / Treatment: Procedure: Angioplasties

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 Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• France
  • Vichy, France, 03200
    • Centre Hospitalier de Vichy (CHV)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morbidity and mortality	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)	during intervention

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Vichy
• Investigators: Study Director: Fabrice ABBADIE, Centre hopsitalier de Vichy

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2021
• Primary Completion (Actual): December 12, 2021
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 14, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: arteriovenous fistula; blood vessel repair; ultrasound angioplasty
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: SAVE1 - CHV 2018-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication ending 5 years following arti
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to Fabrice.Abbadie@ch-vichy.fr
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No