Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler

NCT05545267 | Unknown

• 1 other identifier: SAVE1 - CHV 2018-2
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Arteriovenous Fistula Stenosis

Keywords

blood vessel repair; arteriovenous fistula; ultrasound angioplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Post-angioplasty permeability

  2 years

• Stenosis diameter

  pre-intervention, immediately after the intervention, 1 month

• Endoluminal reference diameter

  pre-intervention, immediately after the intervention, 1 month

• Maximum systolic velocity (VSmax)

  pre-intervention, immediately after the intervention, 1 month

• Ratio of VSmax to upstream

  pre-intervention, immediately after the intervention, 1 month

Interventions

Angioplasties PROCEDURE

Transluminal angioplastie

Also known as: Angioplasties performed under echo-doppler

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier de Vichy: lead

Study Sites (1)

Centre Hospitalier de Vichy (CHV)

Vichy, 03200, France

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Fabrice ABBADIE

  Centre hopsitalier de Vichy

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2022
• First Posted: September 19, 2022
• Study Start: September 17, 2021
• Primary Completion: December 12, 2021
• Study Completion: October 31, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication ending 5 years following arti
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to Fabrice.Abbadie@ch-vichy.fr

Locations

FR (1)