Arteriovenous Fistula Renal Dialysis Devices ObstructionPhase 3FISBALNCT02565953
Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon
A Phase 3 study testing Paclitaxel-releasing PTA balloon catheter and PTA balloon catheter in people with Arteriovenous Fistula Renal Dialysis Devices Obstruction, run by Fundación Pública Andaluza Progreso y Salud at 4 sites in Spain.
Trial summary
In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA) balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal arteries. This device combined the mechanical action of PTA balloon with the antiproliferative effects of paclitaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula Renal Dialysis Devices Obstruction
- What is being tested?
- Paclitaxel-releasing PTA balloon catheter and PTA balloon catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 4 sitesSpain
- Study dates
- Oct 2015to Oct 2018
- Phase
- Phase 3
- 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
- Patient with renal dialysis with arteriovenous fistula (AVF) at least 3 months before.
- Patient diagnosed with AVF stenosis by clinical and radiological criteria
- Sign informed consent
Who cannot join
- Pregnant or breastfeeding
- Patients with AVF stenosis not could be treated with PTA catheter
- Paclitaxel allergy
- Iodinated contrast allergy
- Local or systemic active infection
- Life expectancy less than 12 moths
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitario Juan Ramón Jiménez
Huelva, 21005
Hospital Universitario Puerto Real
Puerto Real, Cádiz, 11510
About this study
In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA) balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal arteries. This device combined the mechanical action of PTA balloon with the antiproliferative effects of paclitaxel. The use of these devices in venous pathology is limited. This devices could improve the treatment of renal dialysis arteriovenous fistula stenosis.
- Being tested
- Paclitaxel-releasing PTA balloon catheter, PTA balloon catheter
- Keywords
- Vascular access devices obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-releasing PTA balloon catheterDevice
PTA balloon catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-releasing PTA balloon catheter | Experimental | Treatment of renal dialysis arteriovenous fistula stenosis with paclitaxel-releasing percutaneous transluminal angioplastic (PTA) balloon catheter. Receives: Device: Paclitaxel-releasing PTA balloon catheter |
| PTA Balloon catheter | Active comparator | Treatment of renal dialysis arteriovenous fistula stenosis with percutaneous transluminal angioplastic (PTA) balloon catheter. Receives: Device: PTA balloon catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from target lesion revascularization
Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion.
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 posted1 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Fistula Renal Dialysis Devices ObstructionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565953
- Sponsor's protocol ID
- FISBAL
- Acronym
- FISBAL
- Status last verified
- Mar 2017
- First submitted
- 30 Sep 2015
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Patency in Post-angioplasty Dysfunctional Arteriovenous Fistula in Renal Dialysis: Paclitaxel-releasing PTA Balloon Catheter vs PTA Balloon
- ClinicalTrials.gov ID
- NCT02565953
- Acronym / sponsor ID
- FISBAL / FISBAL
- Keywords
- Vascular access devices obstruction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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.
In recent years the use of paclitaxel releasing percutaneous transluminal angioplastic (PTA) balloon catheter is spreading in vascular pathology, mainly in stenosis infrainguinal arteries. This device combined the mechanical action of PTA balloon with the antiproliferative effects of paclitaxel. The use of these devices in venous pathology is limited. This devices could improve the treatment of renal dialysis arteriovenous fistula stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-releasing PTA balloon catheter | Experimental | Device: Paclitaxel-releasing PTA balloon catheterTreatment of renal dialysis arteriovenous fistula stenosis with paclitaxel-releasing percutaneous transluminal angioplastic (PTA) balloon catheter. |
| PTA Balloon catheter | Active comparator | Device: PTA balloon catheterTreatment of renal dialysis arteriovenous fistula stenosis with percutaneous transluminal angioplastic (PTA) balloon catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with renal dialysis with arteriovenous fistula (AVF) at least 3 months before.
- Patient diagnosed with AVF stenosis by clinical and radiological criteria
- Sign informed consent
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding
- Patients with AVF stenosis not could be treated with PTA catheter
- Paclitaxel allergy
- Iodinated contrast allergy
- Local or systemic active infection
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 |
|---|---|---|
| Paclitaxel-releasing PTA balloon catheter | Device | Paclitaxel-releasing PTA balloon catheter |
| PTA balloon catheter | Device | PTA Balloon catheter |
Primary outcome
Freedom from target lesion revascularization
Time frame: 12 months
Percentage of patients that do not need any revascularization proceeding during the following twelve months after catheter insertion.
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 Feb 2019.
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel-releasing PTA balloon catheter and PTA balloon catheter in people with Arteriovenous Fistula Renal Dialysis Devices Obstruction, run by Fundación Pública Andaluza Progreso y Salud at 4 sites in Spain.
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 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: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 target lesion revascularization (time frame: 12 months). 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 Feb 2019.