Dialysis Access MalfunctionVOLAIINCT04694287
Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access
An observational study of Dialysis Access Malfunction, run by Attikon Hospital at 3 sites in Greece.
Trial summary
This is a multicenter, prospective study investigating a new concept of intra-procedural percutaneous duplex ultrasound (DUS) volume flow-guided balloon angioplasty for the quantification and optimization of endovascular treatment outcomes of dysfunctional autologous arteriovenous fistulae (AVF). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Dialysis Access Malfunction
- What is being tested?
- Percutaneous DUS volume flow measurements
- How many people
- 100 participants
- Where
- 3 sitesGreece
- Study dates
- 1 Jun 2020to 15 Feb 2023
- How long will I take part?
- 6 Months
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF and assessed with pre-and post-procedural volume flow measurements using percutaneous DUS
Who may be able to join
- Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF
- Signed consent form
- Agree to the study protocol
Who cannot join
- Patients with arteriovenous synthetic grafts
- Patients with contraindication to antiplatelet therapy
- Immature AFVs, not previously used for at least one dialysis session.
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
"Attikon" University General Hospital
Athens, Attica, 12461
Nefrologiki SA Hemodialysis Centre
Athens, Attica
Patras Universityu Hospital
Pátrai, Achaia
About this study
Official title: Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access. The VOLA II Multicenter Study
This is a multicenter, prospective study investigating a new concept of intra-procedural percutaneous duplex ultrasound (DUS) volume flow-guided balloon angioplasty for the quantification and optimization of endovascular treatment outcomes of dysfunctional autologous arteriovenous fistulae (AVF).
Read the detailed description
This is a prospective, multi-center, single-arm observational clinical trial investigating a new functional index of success of endovascular treatment of dysfunctional AVF assessed with intraprocedural percutaneous DUS. The study will include 100 consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Exclusion criteria will be (i) patients with arteriovenous synthetic grafts. (ii) Immature AFVs not previously used for hemodialysis (at least once). Patients' demographical data, dialysis access history, and procedural details will be recorded. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after final balloon dilation, before sheath removal. Clinical follow-up will be set at 6 months after the index procedure. All DUS measurements will be performed using the same imaging protocol. The study's primary endpoints will be (i) the quantification of angioplasty outcome using DUS volume flow analysis before sheath insertion and at the end of the procedure before sheath removal and (ii) to assess the correlation between volume flow at the end of the procedure and clinically driven re-intervention-free rate at defined as the rate of reintervention due to dysfunction recurrence of the treated AVF. Secondary endpoints will be (i) to assess the correlation between volume flow and clinical success defined as high-quality dialysis for a period of at least one month and (ii) identification of independent predictors of re-intervention-free rate.
- Conditions
- Dialysis Access Malfunction
- Being tested
- Percutaneous DUS volume flow measurements
- Keywords
- Percutaneous transluminal angioplasty, Volume-flow measurement, Autologous arteriovenous fistula, Dialysis access, Interventional Radiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous DUS volume flow measurementsDiagnostic test
Volume flow measurements of the AFV will be obtained using intraprocedural DUS just prior to sheath insertion and at the end of the final balloon dilation, before sheath removal.
| Study group | Role | What they receive |
|---|---|---|
| Volume flow group | The study will include consecutive patients undergoing standard fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after final balloon dilation. Receives: Diagnostic Test: Percutaneous DUS volume flow measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of angioplasty outcome
The quantification of angioplasty outcomes will be performed using DUS volume flow analysis
Measured: At the end of the procedure
Correlation between volume flow and clinically-driven reintervention rate
The investigators will use ROC analysis to define cut off values of volume flow at the end of the procedure to predict clinically-driven reintervention rate
Measured: 6 months
Secondary outcomes (3)
Re-intervention-free rate
The clinically driven re-intervention-free rate due to dysfunction recurrence of the treated AVF following endovascular treatment
Measured: 6 months
Identification of independent predictors of reintervention
Multivariable analysis will be performed to identify independent predictors of reintervention-free rate
Measured: 6 months
Procedure related complications
Minor and major procedure related complications will be recorded
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jun 2020
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dialysis Access MalfunctionStudies 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
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Patras, Nefrolgiki SA Hemodialysis Center
- Responsible party
- Principal investigator, Stavros Spiliopoulos, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694287
- Sponsor's protocol ID
- EBD 692
- Acronym
- VOLAII
- Status last verified
- Feb 2023
- First submitted
- 31 Dec 2020
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available after study publication, upon reasonable request
Publications
Spiliopoulos S, Filippou P, Giannikouris IE, Katsanos K, Palialexis K, Grigoriadis S, Kitrou P, Brountzos E, Karnabatidis D. US Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access: The VOLA-II Multicenter Study. Radiology. 2024 Nov;313(2):e233076. doi: 10.1148/radiol.233076.
PubMed 39589250
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access. The VOLA II Multicenter Study
- ClinicalTrials.gov ID
- NCT04694287
- Acronym / sponsor ID
- VOLAII / EBD 692
- Conditions
- Dialysis Access Malfunction
- Keywords
- Percutaneous transluminal angioplasty, Volume-flow measurement, Autologous arteriovenous fistula, Dialysis access, Interventional Radiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Collaborators
- University Hospital of Patras, Nefrolgiki SA Hemodialysis Center
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 5 Jan 2021 (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.
This is a multicenter, prospective study investigating a new concept of intra-procedural percutaneous duplex ultrasound (DUS) volume flow-guided balloon angioplasty for the quantification and optimization of endovascular treatment outcomes of dysfunctional autologous arteriovenous fistulae (AVF).
Detailed description
This is a prospective, multi-center, single-arm observational clinical trial investigating a new functional index of success of endovascular treatment of dysfunctional AVF assessed with intraprocedural percutaneous DUS. The study will include 100 consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Exclusion criteria will be (i) patients with arteriovenous synthetic grafts. (ii) Immature AFVs not previously used for hemodialysis (at least once). Patients' demographical data, dialysis access history, and procedural details will be recorded. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after final balloon dilation, before sheath removal. Clinical follow-up will be set at 6 months after the index procedure. All DUS measurements will be performed using the same imaging protocol. The study's primary endpoints will be (i) the quantification of angioplasty outcome using DUS volume flow analysis before sheath insertion and at the end of the procedure before sheath removal and (ii) to assess the correlation between volume flow at the end of the procedure and clinically driven re-intervention-free rate at defined as the rate of reintervention due to dysfunction recurrence of the treated AVF. Secondary endpoints will be (i) to assess the correlation between volume flow and clinical success defined as high-quality dialysis for a period of at least one month and (ii) identification of independent predictors of re-intervention-free rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volume flow group | – | Diagnostic Test: Percutaneous DUS volume flow measurementsThe study will include consecutive patients undergoing standard fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after final balloon dilation. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF and assessed with pre-and post-procedural volume flow measurements using percutaneous DUS
Key inclusion criteria (3 listed)
- Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF
- Signed consent form
- Agree to the study protocol
Key exclusion criteria (3 listed)
- Patients with arteriovenous synthetic grafts
- Patients with contraindication to antiplatelet therapy
- Immature AFVs, not previously used for at least one dialysis session.
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 |
|---|---|---|
| Percutaneous DUS volume flow measurementsVolume flow measurements of the AFV will be obtained using intraprocedural DUS just prior to sheath insertion and at the end of the final balloon dilation, before sheath removal. | Diagnostic test | Volume flow group |
Primary outcome
Quantification of angioplasty outcome
Time frame: At the end of the procedure
The quantification of angioplasty outcomes will be performed using DUS volume flow analysis
Correlation between volume flow and clinically-driven reintervention rate
Time frame: 6 months
The investigators will use ROC analysis to define cut off values of volume flow at the end of the procedure to predict clinically-driven reintervention rate
3 secondary outcomes
Re-intervention-free rate
Time frame: 6 months
Identification of independent predictors of reintervention
Time frame: 6 months
Procedure related complications
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 39589250Spiliopoulos S, Filippou P, Giannikouris IE, Katsanos K, Palialexis K, Grigoriadis S, Kitrou P, Brountzos E, Karnabatidis D. US Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access: The VOLA-II Multicenter Study. Radiology. 2024 Nov;313(2):e233076. doi: 10.1148/radiol.233076.
- Individual participant dataSharing planned: Yes. Available after study publication, upon reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis Access Malfunction, run by Attikon Hospital at 3 sites in Greece.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quantification of angioplasty outcome (time frame: At the end of the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04694287, which also lists 1 linked publication.
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 21 Feb 2023.