Arteriovenous Fistula StenosisSAVENCT05545267
Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler
An observational study of Arteriovenous Fistula Stenosis, run by Centre Hospitalier de Vichy at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula Stenosis
- What is being tested?
- Angioplasties
- Type of treatment
- Surgery or procedure
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with end-stage renal disease treated by dialysis whose AVF angioplasties is performed under echo-doppler at the Vcihy Hospital Center
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Arteriovenous Fistula Stenosis
- Being tested
- Angioplasties
- Keywords
- blood vessel repair, arteriovenous fistula, ultrasound angioplasty
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioplastiesProcedure or surgery
Also called Angioplasties performed under echo-doppler
Transluminal angioplastie
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: during intervention
Secondary outcomes (11)
Post-angioplasty permeability
Post-angioplasty primary permeability, and post-angioplasty primary assisted permeability and post-angioplasty secondary permeability over the entire follow-up period
Measured: 2 years
Stenosis diameter
Variation of the stenosis diameter
Measured: pre-intervention, immediately after the intervention, 1 month
Endoluminal reference diameter
Variation of the endoluminal diameter
Measured: pre-intervention, immediately after the intervention, 1 month
Maximum systolic velocity (VSmax)
Variation of the maximum systolic velocity
Measured: pre-intervention, immediately after the intervention, 1 month
Ratio of VSmax to upstream
Varation of Ratio of VSmax to upstream
Measured: pre-intervention, immediately after the intervention, 1 month
End-diastolic velocity
Variation of end-diastolic velocity
Measured: pre-intervention, immediately after the intervention, 1 month
Diameter of the anastomosis
Variation of anastomosis diameter
Measured: pre-intervention, immediately after the intervention, 1 month
Brachial artery Maximum flow
Variation of brachial artery maximum flow
Measured: pre-intervention, immediately after the intervention, 1 month
Brachial artery end-diastolic velocity (EDV)
Varaition of Brachial artery end-diastolic velocity
Measured: pre-intervention, immediately after the intervention, 1 month
Brachial artery maximum systolic velocity
Variation of brachial artery maximum systolic velocity
Measured: pre-intervention, immediately after the intervention, 1 month
Brachial artery Resistance Index
Variation of brachial artery Resistance Index
Measured: pre-intervention, immediately after the intervention, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start17 Sep 2021
- Primary completion12 Dec 2021
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Fistula StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Vichy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice ABBADIE, Study director, Centre hopsitalier de Vichy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545267
- Sponsor's protocol ID
- SAVE1 - CHV 2018-2
- Acronym
- SAVE
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring of Dialysis Vascular Accesses During Angioplasty Under Echodoppler (SAVE)
- ClinicalTrials.gov ID
- NCT05545267
- Acronym / sponsor ID
- SAVE / SAVE1 - CHV 2018-2
- Conditions
- Arteriovenous Fistula Stenosis
- Keywords
- blood vessel repair, arteriovenous fistula, ultrasound angioplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Centre Hospitalier de VichyUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with end-stage renal disease treated by dialysis whose AVF angioplasties is performed under echo-doppler at the Vcihy Hospital Center
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AngioplastiesAlso: Angioplasties performed under echo-dopplerTransluminal angioplastie | Procedure or surgery | – |
Primary outcome
morbidity and mortality
Time frame: 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)
11 secondary outcomes
Post-angioplasty permeability
Time frame: 2 years
Stenosis diameter
Time frame: pre-intervention, immediately after the intervention, 1 month
Endoluminal reference diameter
Time frame: pre-intervention, immediately after the intervention, 1 month
Maximum systolic velocity (VSmax)
Time frame: pre-intervention, immediately after the intervention, 1 month
Ratio of VSmax to upstream
Time frame: pre-intervention, immediately after the intervention, 1 month
End-diastolic velocity
Time frame: pre-intervention, immediately after the intervention, 1 month
Diameter of the anastomosis
Time frame: pre-intervention, immediately after the intervention, 1 month
Brachial artery Maximum flow
Time frame: pre-intervention, immediately after the intervention, 1 month
Brachial artery end-diastolic velocity (EDV)
Time frame: pre-intervention, immediately after the intervention, 1 month
Brachial artery maximum systolic velocity
Time frame: pre-intervention, immediately after the intervention, 1 month
Brachial artery Resistance Index
Time frame: pre-intervention, immediately after the intervention, 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
Related trials for Arteriovenous Fistula Stenosis
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Active, not recruiting
A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice ABBADIE study director
Centre hopsitalier de Vichy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula Stenosis, run by Centre Hospitalier de Vichy at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity and mortality (time frame: during intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.