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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05545267
Other study ID # SAVE1 - CHV 2018-2
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 17, 2021
Est. completion date October 31, 2022

Study information

Verified date September 2022
Source Centre Hospitalier de Vichy
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 144
Est. completion date October 31, 2022
Est. primary completion date December 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Procedure:
Angioplasties
Transluminal angioplastie

Locations

Country Name City State
France Centre Hospitalier de Vichy (CHV) Vichy

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier de Vichy

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Stenosis diameter Variation of the stenosis diameter pre-intervention, immediately after the intervention, 1 month
Secondary Endoluminal reference diameter Variation of the endoluminal diameter pre-intervention, immediately after the intervention, 1 month
Secondary Maximum systolic velocity (VSmax) Variation of the maximum systolic velocity pre-intervention, immediately after the intervention, 1 month
Secondary Ratio of VSmax to upstream Varation of Ratio of VSmax to upstream pre-intervention, immediately after the intervention, 1 month
Secondary End-diastolic velocity Variation of end-diastolic velocity pre-intervention, immediately after the intervention, 1 month
Secondary Diameter of the anastomosis Variation of anastomosis diameter pre-intervention, immediately after the intervention, 1 month
Secondary Brachial artery Maximum flow Variation of brachial artery maximum flow pre-intervention, immediately after the intervention, 1 month
Secondary Brachial artery end-diastolic velocity (EDV) Varaition of Brachial artery end-diastolic velocity pre-intervention, immediately after the intervention, 1 month
Secondary Brachial artery maximum systolic velocity Variation of brachial artery maximum systolic velocity pre-intervention, immediately after the intervention, 1 month
Secondary Brachial artery Resistance Index Variation of brachial artery Resistance Index pre-intervention, immediately after the intervention, 1 month
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