Dialysis Access MalfunctionVOLANCT04430478
Volume Flow-guided Angioplasty of Dysfunctional Dialysis Access
A study testing Volume flow guided angioplasty in people with Dialysis Access Malfunction, run by Attikon Hospital at 3 sites in Greece.
Trial summary
This is a pilot 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 years and older
- Conditions the study is for
- Dialysis Access Malfunction
- What is being tested?
- Volume flow guided angioplasty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesGreece
- Study dates
- 10 Jun 2019to 21 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF
- Signed consent form
- Agree to the imaging protocol
Who cannot join
- not available volume flow values at the time of AVF maturation
- patients with arteriovenous synthetic grafts.
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
"Attikon" University General Hospital
Athens, Attica, 12461
Medifil SA Hemodialysis Centre
Athens, Attica
Nefrologiki SA Hemodialysis Centre
Athens, Attica
About this study
Official title: VOLume Flow-guided Angioplasty of Dysfunctional Autologous Arteriovenous Fistula. The VOLA Pilot Study
This is a pilot 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, single-center, single-arm clinical trial introducing a new functional index of clinical success of endovascular treatment and investigating the feasibility of volume flow-guided balloon angioplasty of dysfunctional AVF assessed with intraprocedural percutaneous DUS. The study will include consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF in the investigator's center. Exclusion criteria will be: (i) not available volume flow values at the time of AVF maturation, (ii) patients with arteriovenous synthetic grafts. 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 each balloon dilation. Volume flow measurements will be correlated with digital subtraction angiography quantitative vessel analysis (QVA) performed by an independent investigator blinded to the volume flow analysis outcomes. Follow up DUS imaging including volume-flow assessment will be set at 24h, 6, and 12 months after the index procedure, while fistulograms with QVA analysis will be performed at 6 and 12 months. All DUS measurements will be performed using the same imaging protocol and the same operator. The study's primary endpoints will be (i) the quantification of angioplasty outcome using sequential DUS volume flow analysis following each balloon catheter dilation and (ii) to assess the correlation between volume flow and clinical success defined as high-quality dialysis for a period of at least one month. Secondary endpoints will be (i) re-intervention-free interval defined as the time interval between endovascular treatment and reintervention due to dysfunction recurrence of the treated AVF and (ii) correlation between volume flow and QVA measurements.
- Conditions
- Dialysis Access Malfunction
- Being tested
- Volume flow guided angioplasty
- Keywords
- Percutaneous transluminal angioplasty, Volume-flow measurment, Autologous arteriovenous fistula, Dialysis access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume flow guided angioplastyDiagnostic test
Volume flow measurements using DUS will be obtained at the end of each balloon dilation, at 24 hours, 6 months, and one year after index procedure.
| Study group | Role | What they receive |
|---|---|---|
| Volume flow group | Experimental | Consecutive patients undergoing sequential volume flow measurements using percutaneous DUS Receives: Diagnostic Test: Volume flow guided angioplasty |
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 sequential DUS volume flow analysis
Measured: At the end of the procedure
Duplex Ultrasound volume flow values achieved following angioplasty and clinical success
The investigators will use ROC analysis to define a cut off value of volume flow increase (ml per minute) at the end of the procedure to predict clinical success.
Measured: 1 month
Secondary outcomes (2)
Re-intervention-free interval
The time interval between endovascular treatment and reintervention due to dysfunction recurrence of the treated AVF
Measured: 6 months
Comparison of Duplex Ultrasound volume flow values with digital subtraction angiography QVA measurements.
To assess wheather a significant volume flow decrease of >50% measured by Duplex ultrasound indicates an analougously significant late lumen loss (mm) of the target lesion measured with QVA analysis of digital subtracted venography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start10 Jun 2019
- Primary completion21 Dec 2020
- Study completion21 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will include consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after each balloon dilation. Volume flow measurements will be correlated with digital subtraction angiography quantitative vessel analysis (QVA) performed by an independent investigator blinded to the volume flow analysis outcomes. Follow up DUS imaging including volume-flow assessment will be set at 24h, 6, and 12 months, while fistulograms with QVA analysis will be performed at 6 and 12 months.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Spiliopoulos, Attikon Hospital
- Investigators
- Stavros Spiliopoulos, MD, PhD, EBIR, Principal investigator, ATTIKO University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430478
- Sponsor's protocol ID
- 323
- Acronym
- VOLA
- Status last verified
- Dec 2020
- First submitted
- 10 Jun 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to make individual participant data (IPD) available to other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VOLume Flow-guided Angioplasty of Dysfunctional Autologous Arteriovenous Fistula. The VOLA Pilot Study
- ClinicalTrials.gov ID
- NCT04430478
- Acronym / sponsor ID
- VOLA / 323
- Conditions
- Dialysis Access Malfunction
- Keywords
- Percutaneous transluminal angioplasty, Volume-flow measurment, Autologous arteriovenous fistula, Dialysis access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 21 Dec 2020 (actual)
- First posted
- 12 Jun 2020 (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 pilot 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, single-center, single-arm clinical trial introducing a new functional index of clinical success of endovascular treatment and investigating the feasibility of volume flow-guided balloon angioplasty of dysfunctional AVF assessed with intraprocedural percutaneous DUS. The study will include consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF in the investigator's center. Exclusion criteria will be: (i) not available volume flow values at the time of AVF maturation, (ii) patients with arteriovenous synthetic grafts. 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 each balloon dilation. Volume flow measurements will be correlated with digital subtraction angiography quantitative vessel analysis (QVA) performed by an independent investigator blinded to the volume flow analysis outcomes. Follow up DUS imaging including volume-flow assessment will be set at 24h, 6, and 12 months after the index procedure, while fistulograms with QVA analysis will be performed at 6 and 12 months. All DUS measurements will be performed using the same imaging protocol and the same operator. The study's primary endpoints will be (i) the quantification of angioplasty outcome using sequential DUS volume flow analysis following each balloon catheter dilation and (ii) to assess the correlation between volume flow and clinical success defined as high-quality dialysis for a period of at least one month. Secondary endpoints will be (i) re-intervention-free interval defined as the time interval between endovascular treatment and reintervention due to dysfunction recurrence of the treated AVF and (ii) correlation between volume flow and QVA measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will include consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after each balloon dilation. Volume flow measurements will be correlated with digital subtraction angiography quantitative vessel analysis (QVA) performed by an independent investigator blinded to the volume flow analysis outcomes. Follow up DUS imaging including volume-flow assessment will be set at 24h, 6, and 12 months, while fistulograms with QVA analysis will be performed at 6 and 12 months.
| Arm | Type | Receives |
|---|---|---|
| Volume flow group | Experimental | Diagnostic Test: Volume flow guided angioplastyConsecutive patients undergoing sequential volume flow measurements using percutaneous DUS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF
- Signed consent form
- Agree to the imaging protocol
Key exclusion criteria (2 listed)
- not available volume flow values at the time of AVF maturation
- patients with arteriovenous synthetic grafts.
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 |
|---|---|---|
| Volume flow guided angioplastyVolume flow measurements using DUS will be obtained at the end of each balloon dilation, at 24 hours, 6 months, and one year after index procedure. | 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 sequential DUS volume flow analysis
Duplex Ultrasound volume flow values achieved following angioplasty and clinical success
Time frame: 1 month
The investigators will use ROC analysis to define a cut off value of volume flow increase (ml per minute) at the end of the procedure to predict clinical success.
2 secondary outcomes
Re-intervention-free interval
Time frame: 6 months
Comparison of Duplex Ultrasound volume flow values with digital subtraction angiography QVA measurements.
Time frame: 6 months
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 22 Dec 2020.
- Individual participant dataSharing planned: Yes. The investigators plan to make individual participant data (IPD) available to other researchers upon 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.
Stavros Spiliopoulos, MD, PhD, EBIR principal investigator
ATTIKO University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volume flow guided angioplasty in people with 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 2 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 22 Dec 2020. 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?
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 22 Dec 2020.