Complication of HemodialysisAPERTONCT02558153
RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula
A study testing DEB, drug eluting balloon and standard PTA in people with Complication of Hemodialysis and Vascular Access Complication, run by Groene Hart Ziekenhuis at 10 sites in 2 countries.
Trial summary
A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients with haemodialysis access stenoses. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Complication of Hemodialysis, Vascular Access Complication
- What is being tested?
- DEB, drug eluting balloon and standard PTA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jun 2015to 3 Jul 2019
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All criteria 1-10 must apply for inclusion.
- Age > 18 years and < 90 years
- Patient or legally authorized representative providing written informed consent
- Patient willing and likely to comply with the follow up schedule
- Patients with previously well functioning hemodialysis access on the arm presenting with any of the following clinical abnormalities as defined in the NKF-DOQI-protocol criteria (National Kidney Foundation 2000):
- Abnormal physical examination findings (change in bruits, thrill, pulse, etc
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- Abnormal urea recirculation measurements
- Elevated venous pressure during dialysis
- Decreased access flow
- Previous thrombosis in the access line
- Development of collateral veins
- Limb swelling
- Low arterial pressure during dialysis
- Unexplained decreases in dialysis dose
- Target Lesion is hemodynamically relevant and consists of MLD ≤ 3 mm. For enrolment this criterium is judged by the local investigator. For final analysis this criterium is based on the result of central reading of the angiogram.
- Target Lesion(s) is a de-novo or (non-stent) restenosis
- Target lesion(s) in dialysis fistulas is located at the anastomosis or in the outflow venous trajectory up to the level (but excluding) the subclavian vein
- Target lesion(s) in dialysis grafts is located at the arterial or venous anastomosis, inside the graft, or in the outflow venous trajectory up to the level (but excluding) the subclavian vein
- Multiple Target Lesions are allowed per patient which can be treated by a number of APERTO DEB with aggregate max length of 160 mm
- NON Target Lesions (i.e. in the subclavian vein) must be successfully treated with standard PTA prior to the Target Lesion.
Who cannot join
- None of criteria 1-12 must apply for inclusion.
- Patients unable to give informed consent
- Patients enrolled in another study with any investigational drug or device
- Patients previously enrolled in the APERTO trial.
- Female patients of child bearing potential without a negative pregnancy test at the time of intervention
- Major surgical procedures within 30 days prior to this study or planned within 30 days of entry into this study
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- Patients previously treated with a DEB in the hemodialysis access.
- Patients with a trombosed hemodialysis access.
- Immature hemodialysis access (unusable due to insufficient shunt flow volume)
- Lesion treated within 30 days prior to screening
- Failure to successfully treat non-target lesions prior the Target Lesion
- In stent restenosis
- Patients with any known allergy, hypersensitivity or intolerance to ASA, clopidogrel or ticlopidine, paclitaxel, or contrast medium.
- Graft infection
- Life expectancy < 1 years
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Netherlands8 sites
St Lucas Andreas Hospital
Amsterdam, North Holland, 1061 AE
Catharina ziekenhuis
Eindhoven, North Brabant, 5623 EJ
Groene Hart Ziekenhuis
Gouda, South Holland, 2803 HH
UMC Groningen
Groningen, 9700 RB
Atrium Medisch Centrum. Department of radiology
Heerlen, Limburg, 6419 PC
MC Leeuwarden
Leeuwarden, Provincie Friesland, 8934 AD
Erasmus MC
Rotterdam, South Holland, 3015CE
MC Haaglanden
The Hague, South Holland, 2512 VA
Belgium2 sites
ZNA Stuivenberg
Antwerp, 2060
UZ Leuven
Leuven, Vlaams Brabant, 3000
About this study
Official title: A Randomized Trial of Aperto Paclitaxel Eluting Dilatation Catheter Compared to POBA in Dialysis Fistula
A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients with haemodialysis access stenoses.
Read the detailed description
Prospective multicenter randomized (1:1) Investigator Sponsored Trial, in which 150 consecutive patients candidates for percutaneous intervention of haemodialysis access will be randomly assigned to one of two study arms:
- Treatment Arm: paclitaxel drug-eluting balloon (DEB) dilatation using the APERTO-balloon
- Control Arm: standard percutaneous transluminal angioplasty (PTA).
The aim is to evaluate the safety and efficacy of paclitaxel drug-eluting balloon (DEB) for the reduction of restenosis in haemodialysis shunts compared to standard percutaneous transluminal angioplasty (PTA).
- Being tested
- DEB, drug eluting balloon, standard PTA
- Keywords
- drug eluting balloon, percutaneous balloon angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEB, drug eluting balloonDevice
Also called Paclitaxel eluting balloon
Percutaneous angioplasty performed with a DEB - drug eluting balloon
standard PTADevice
Also called POBA
Percutaneous angioplasty performed with a standard balloon
| Study group | Role | What they receive |
|---|---|---|
| DEB - drug eluting balloon (APERTO) | Experimental | Percutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting APERTO balloon Receives: Device: DEB, drug eluting balloon |
| standard PTA | Active comparator | Percutaneous balloon angioplasty performed with the clinical standard, that is, a non-drug-eluting balloon (POBA, plain old balloon angioplasty). Receives: Device: standard PTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate functioning of the hemodialysis access
Period of adequate functioning of the hemodialysis access after treatment, defined according to the NKF-DOQI protocol criteria
Measured: 12 months
Secondary outcomes (9)
device success
ability of the DEB to be delivered, inflated at pressure ≤ RBP, and retrieved from the Target Lesion without burst
Measured: index procedure (day 0)
Technical Success
achievement of a lumen diameter of at least 70% of the nominal diameter of either the DEB or the post dilatation PTA balloon (whichever is bigger) by visual estimate and without bail-out stenting
Measured: index procedure (day 0)
Clinical Success
improvement in haemodialysis access failure and resumption of normal dialysis for at least one dialysis session after the index procedure
Measured: 12 months
Procedural Success
Technical Success without the occurrence of MAE (MAE defined here as: death, stroke, thrombotic occlusion, allergic reaction, pulmonary events (including pulmonary edema)
Measured: Index procedure (day 0)
MAE - major adverse events
MAE defined as: death or stroke
Measured: 12 months
thrombotic occlusion of target lesion
thrombotic occlusion of target lesion
Measured: 12 months
thrombotic occlusion of target hemodialysis access
thrombotic occlusion of target hemodialysis access
Measured: 12 months
Clinically driven Target Lesion Revascularization (TLR)
Clinically driven Target Lesion Revascularization (TLR)
Measured: 12 months
Clinically driven Target Shunt Revascularization (TSR)
Clinically driven Target Shunt Revascularization (TSR)
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 posted23 Sep 2015 (estimated)
- Study startJun 2015
- Primary completion3 Jul 2019
- Study completion3 Jul 2019
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 Complication of HemodialysisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groene Hart Ziekenhuis
- Sponsor type
- University, hospital or other
- Collaborators
- Archer Research
- Responsible party
- Principal investigator, Dr Peter M.T. Pattynama, Groene Hart Ziekenhuis
- Investigators
- Peter MT Pattynama, MD, PhD, Principal investigator, Groene Hart Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558153
- Sponsor's protocol ID
- NL44059.058.13
- Acronym
- APERTO
- Status last verified
- May 2020
- First submitted
- 7 Jun 2015
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Maleux G, van der Linden E, Heijboer RJJ, Serafino GP, Wust AFJ, Dol JA, Gabriels K, Pattynama P. Multicenter Randomized Controlled Trial of APERTO-Paclitaxel Drug-Eluting Balloon Angioplasty Versus Standard Percutaneous Transluminal Angioplasty in Dysfunctional Hemodialysis Grafts and Native Fistulae. J Endovasc Ther. 2025 Oct;32(5):1580-1588. doi: 10.1177/15266028231215212. Epub 2023 Dec 6.
PubMed 38053508
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Aperto Paclitaxel Eluting Dilatation Catheter Compared to POBA in Dialysis Fistula
- ClinicalTrials.gov ID
- NCT02558153
- Acronym / sponsor ID
- APERTO / NL44059.058.13
- Keywords
- drug eluting balloon, percutaneous balloon angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Groene Hart ZiekenhuisUniversity, hospital or other
- Collaborators
- Archer Research
- Study start
- Jun 2015
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 3 Jul 2019 (actual)
- First posted
- 23 Sep 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.
A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients with haemodialysis access stenoses.
Detailed description
Prospective multicenter randomized (1:1) Investigator Sponsored Trial, in which 150 consecutive patients candidates for percutaneous intervention of haemodialysis access will be randomly assigned to one of two study arms:
- Treatment Arm: paclitaxel drug-eluting balloon (DEB) dilatation using the APERTO-balloon
- Control Arm: standard percutaneous transluminal angioplasty (PTA).
The aim is to evaluate the safety and efficacy of paclitaxel drug-eluting balloon (DEB) for the reduction of restenosis in haemodialysis shunts compared to standard percutaneous transluminal angioplasty (PTA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB - drug eluting balloon (APERTO) | Experimental | Device: DEB, drug eluting balloonPercutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting APERTO balloon |
| standard PTA | Active comparator | Device: standard PTAPercutaneous balloon angioplasty performed with the clinical standard, that is, a non-drug-eluting balloon (POBA, plain old balloon angioplasty). |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- All criteria 1-10 must apply for inclusion.
- Age > 18 years and < 90 years
- Patient or legally authorized representative providing written informed consent
- Patient willing and likely to comply with the follow up schedule
- Patients with previously well functioning hemodialysis access on the arm presenting with any of the following clinical abnormalities as defined in the NKF-DOQI-protocol criteria (National Kidney Foundation 2000):
Key exclusion criteria (15 listed)
- None of criteria 1-12 must apply for inclusion.
- Patients unable to give informed consent
- Patients enrolled in another study with any investigational drug or device
- Patients previously enrolled in the APERTO trial.
- Female patients of child bearing potential without a negative pregnancy test at the time of intervention
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 |
|---|---|---|
| DEB, drug eluting balloonAlso: Paclitaxel eluting balloonPercutaneous angioplasty performed with a DEB - drug eluting balloon | Device | DEB - drug eluting balloon (APERTO) |
| standard PTAAlso: POBAPercutaneous angioplasty performed with a standard balloon | Device | standard PTA |
Primary outcome
Adequate functioning of the hemodialysis access
Time frame: 12 months
Period of adequate functioning of the hemodialysis access after treatment, defined according to the NKF-DOQI protocol criteria
9 secondary outcomes
device success
Time frame: index procedure (day 0)
Technical Success
Time frame: index procedure (day 0)
Clinical Success
Time frame: 12 months
Procedural Success
Time frame: Index procedure (day 0)
MAE - major adverse events
Time frame: 12 months
thrombotic occlusion of target lesion
Time frame: 12 months
thrombotic occlusion of target hemodialysis access
Time frame: 12 months
Clinically driven Target Lesion Revascularization (TLR)
Time frame: 12 months
Clinically driven Target Shunt Revascularization (TSR)
Time frame: 12 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 5 May 2020.
- Derived from this study: PubMed 38053508Maleux G, van der Linden E, Heijboer RJJ, Serafino GP, Wust AFJ, Dol JA, Gabriels K, Pattynama P. Multicenter Randomized Controlled Trial of APERTO-Paclitaxel Drug-Eluting Balloon Angioplasty Versus Standard Percutaneous Transluminal Angioplasty in Dysfunctional Hemodialysis Grafts and Native Fistulae. J Endovasc Ther. 2025 Oct;32(5):1580-1588. doi: 10.1177/15266028231215212. Epub 2023 Dec 6.
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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.
Peter MT Pattynama, MD, PhD principal investigator
Groene Hart Ziekenhuis
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEB, drug eluting balloon and standard PTA in people with Complication of Hemodialysis and Vascular Access Complication, run by Groene Hart Ziekenhuis at 10 sites in 2 countries.
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 20 inclusion and 15 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 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands, Belgium. 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?
Adequate functioning of the hemodialysis access (time frame: 12 months). 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 NCT02558153, 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 5 May 2020.