Vascular DiseasesNCT05173857
Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) in the Treatment of Failing Dialysis Access
A study testing Advance PTX, Advance LP (Low Profile) and Paclitaxel (PTX) in people with Vascular Diseases and Kidney Diseases, run by Skane University Hospital.
Trial summary
Background Conventional percutaneous transluminal angioplasty is still considered standard treatment for treatment of dysfunctional haemodialysis fistulas and grafts. The most important drawback with this treatment is frequent restenosis leading to a high number of secondary procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases, Kidney Diseases
- What is being tested?
- Advance PTX, Advance LP (Low Profile) and Paclitaxel (PTX)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to 31 Jul 2018
- 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
- Active dialysis with a mature upper extremity dysfunctional haemodialysis access
- Primary stenosis or nonstented restenosis in a native AV fistula or at graft-venous location
- Adult (>18 years)
- Target vessel diameter 3-8mm
Who cannot join
- Thrombosed access
- In stent restenosis
- Pregnancy
- Age less than 18 years
About this study
Official title: Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) for the Treatment of Failing Dialysis Access. A Prospective Randomized Trial
Background Conventional percutaneous transluminal angioplasty is still considered standard treatment for treatment of dysfunctional haemodialysis fistulas and grafts. The most important drawback with this treatment is frequent restenosis leading to a high number of secondary procedures. There is conflicting evidence in the literature regarding primary or secondary treatment with drug eluting balloons (DEB). These balloons deliver Paclitaxel locally, which acts as an antiproliferative drug and may improve treatment outcomes.
Methods This study was conducted as a prospective 1:1 randomized single centre clinical trial. Participants had primary or re-stenotic lesions in native upper extremity arteriovenous fistulas or at the graft-venous anastomosis. Patients were randomized to direct primary dilatation, with either a standard balloon or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR), access circuit revascularization or thrombosis, functional status of access circuit at 12 months. Secondary endpoints were procedural complications, procedural success, follow up survival and time to target lesion revascularization.
- Conditions
- Vascular Diseases, Kidney Diseases
- Being tested
- Advance PTX, Advance LP (Low Profile), Paclitaxel (PTX)
- Keywords
- Haemodialysis, Fistula, Stenosis, Paclitaxel, Drug-eluting balloon, Angioplasty
- Medical subject headings
- Vascular Diseases, Kidney Diseases, Fistula, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance PTXDevice
PTA in Dysfunctional Haemodialysis Access
Advance LP (Low Profile)Device
Plain Old Balloon Angioplasty (POBA)
Paclitaxel (PTX)Drug
Paclitaxel (PTX)
| Study group | Role | What they receive |
|---|---|---|
| Drug Eluting Balloon (DEB) | Active comparator | Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology.
Drug: Paclitaxel (PTX). Name of Device: Advance PTX Receives: Device: Advance PTX; Drug: Paclitaxel (PTX) |
| Plain Old Balloon Angioplasty (POBA) | Placebo comparator | Percutaneous Angioplasty in dysfunctional arteriovenous access, using Plain Old Balloon Angioplasty.
Drug: None. Name of Device: Advance LP (Low Profile) Receives: Device: Advance LP (Low Profile) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from restenosis in treated vascular access
Freedom from Restenosis and Target Lesion Revascularization (TLR) during 12 months follow up
Measured: 12 months
Stenosis or occlusion in treated vascular access
Treated Denovo Stenosis or Occlusion during 12 months follow up, i.e a new stenosis >50%, not treated before in the study, and at another location in the vascular access circuit (upper arm haemodialysis access)
Measured: 12 months
Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months
Functional status of vascular access.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start1 Mar 2014
- Primary completion31 Jul 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torbjorn Fransson, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173857
- Sponsor's protocol ID
- TF1
- Status last verified
- Dec 2021
- First submitted
- 10 Nov 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) for the Treatment of Failing Dialysis Access. A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05173857
- Acronym / sponsor ID
- TF1
- Conditions
- Vascular Diseases, Kidney Diseases
- Keywords
- Haemodialysis, Fistula, Stenosis, Paclitaxel, Drug-eluting balloon, Angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 30 Dec 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.
Background Conventional percutaneous transluminal angioplasty is still considered standard treatment for treatment of dysfunctional haemodialysis fistulas and grafts. The most important drawback with this treatment is frequent restenosis leading to a high number of secondary procedures. There is conflicting evidence in the literature regarding primary or secondary treatment with drug eluting balloons (DEB). These balloons deliver Paclitaxel locally, which acts as an antiproliferative drug and may improve treatment outcomes.
Methods This study was conducted as a prospective 1:1 randomized single centre clinical trial. Participants had primary or re-stenotic lesions in native upper extremity arteriovenous fistulas or at the graft-venous anastomosis. Patients were randomized to direct primary dilatation, with either a standard balloon or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR), access circuit revascularization or thrombosis, functional status of access circuit at 12 months. Secondary endpoints were procedural complications, procedural success, follow up survival and time to target lesion revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Eluting Balloon (DEB) | Active comparator | Device: Advance PTX, Drug: Paclitaxel (PTX)Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology. Drug: Paclitaxel (PTX). Name of Device: Advance PTX |
| Plain Old Balloon Angioplasty (POBA) | Placebo comparator | Device: Advance LP (Low Profile)Percutaneous Angioplasty in dysfunctional arteriovenous access, using Plain Old Balloon Angioplasty. Drug: None. Name of Device: Advance LP (Low Profile) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active dialysis with a mature upper extremity dysfunctional haemodialysis access
- Primary stenosis or nonstented restenosis in a native AV fistula or at graft-venous location
- Adult (>18 years)
- Target vessel diameter 3-8mm
Key exclusion criteria (4 listed)
- Thrombosed access
- In stent restenosis
- Pregnancy
- Age less than 18 years
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 |
|---|---|---|
| Advance PTXPTA in Dysfunctional Haemodialysis Access | Device | Drug Eluting Balloon (DEB) |
| Advance LP (Low Profile)Plain Old Balloon Angioplasty (POBA) | Device | Plain Old Balloon Angioplasty (POBA) |
| Paclitaxel (PTX)Paclitaxel (PTX) | Drug | Drug Eluting Balloon (DEB) |
Primary outcome
Freedom from restenosis in treated vascular access
Time frame: 12 months
Freedom from Restenosis and Target Lesion Revascularization (TLR) during 12 months follow up
Stenosis or occlusion in treated vascular access
Time frame: 12 months
Treated Denovo Stenosis or Occlusion during 12 months follow up, i.e a new stenosis >50%, not treated before in the study, and at another location in the vascular access circuit (upper arm haemodialysis access)
Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months
Time frame: 12 months
Functional status of vascular access.
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 14 Jan 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Advance PTX, Advance LP (Low Profile) and Paclitaxel (PTX) in people with Vascular Diseases and Kidney Diseases, run by Skane University Hospital.
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 4 inclusion and 4 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Freedom from restenosis in treated vascular access (time frame: 12 months). The study lists 3 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 14 Jan 2022.