Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler

Arteriovenous Fistula Stenosis Clinical Trial

— SAVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05545267
• Other study ID #: SAVE1 - CHV 2018-2
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Fistula Stenosis
• Fistula

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