Stenosis of Arteriovenous Dialysis FistulaPhase 3ACADEMICNCT03068845
Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
A Phase 3 study testing Drug-eluting balloon angioplasty (DEBA) and Conventional Balloon Angioplasty (CBA) in people with Stenosis of Arteriovenous Dialysis Fistula, run by Singapore General Hospital.
Trial summary
The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting balloon compared to conventional balloon in balloon-assisted maturation of non-maturing arteriovenous fistula in adult renal failure patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stenosis of Arteriovenous Dialysis Fistula
- What is being tested?
- Drug-eluting balloon angioplasty (DEBA) and Conventional Balloon Angioplasty (CBA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Mar 2020
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-maturing upper limb arteriovenous fistula (AVF) created 6-24 weeks ago with any one of the following:
- Non-maturing on physical examination, or
- Failed initial cannulation, or
- Failure to achieve prescribed dialysis within prescribed time frame.
- Stenosis (>50%) along AVF circuit from anastomosis up to, but not including, the subclavian vein.
- Successful guidewire crossing of target lesion.
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- >= 21 years old.
- Informed consent given.
- Patient willing and able to return for 3 month, 6 month fistulogram and 12 month clinic follow up.
Who cannot join
- Thrombosed non-maturing AVF
- Target lesion is longer than 8 cm
- Previous endovascular therapy for non-maturation of the trial AVF
- Baseline systolic blood pressure less than 100 mmHg
- Non-maturing AVF is not planned to be used for dialysis in the immediate future (e.g. chronic kidney disease not requiring haemodialysis yet)
- Coagulopathy (prothrombin time or activated partial thromboplastin time >1.5 times the median of normal range) that cannot be managed adequately with periprocedural transfusion
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- Thrombocytopenia (platelet count <50,000 /μL) that cannot be managed adequately with periprocedural transfusion
- Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication
- Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel
- Acute infection over proposed puncture site
- Women who are breastfeeding, pregnant or planning on becoming pregnant during study.
- Men who are planning on fathering children during the study.
- Participant with medical conditions which in the opinion of the investigator may cause non-compliance with protocol.
- Currently participating in an investigational drug, biologic or device trial that may have an impact on the AVF or previous enrollment in this study.
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting balloon compared to conventional balloon in balloon-assisted maturation of non-maturing arteriovenous fistula in adult renal failure patients.
Read the detailed description
This is a single-centre study, where a total of 124 subjects with non-maturing arteriovenous fistula will be randomised (1:1) to either experimental or active comparator arm. Randomisation will be stratified by location of arteriovenous fistula (above versus below elbow).
Each subject will undergo fistulogram in order to assess eligibility criteria. In the event that there is more than 1 eligible stenosis, the most severe stenosis will be considered the target (study) lesion. All other lesions will be treated in the conventional manner. No coil embolisation of collaterals will be performed in the index treatment.
If the subject is allocated to the experimental arm, the target lesion will be treated with pre-dilatation with a conventional balloon before application of the drug-eluting ballon.
If the subject is allocated to the active comparator arm, the target lesion will be treated with a conventional balloon.
High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%).
All subjects will be prescribed 1 month of dual antiplatelets (aspirin and clopidogrel), followed by 5 months of aspirin.
The duration of the study is 12 months. Follow up visits include:
- Two-weekly follow up visits in the first 3 months after intervention until the patient is deemed ready for trial cannulation.
- At 3 months after intervention to assess primary outcome.
- At 6 months after intervention for a fistulogram
- At 12 months after intervention for study closure.
- Being tested
- Drug-eluting balloon angioplasty (DEBA), Conventional Balloon Angioplasty (CBA)
- Keywords
- non-maturing arteriovenous fistula, stenosis of arteriovenous fistula, drug-eluting balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug-eluting balloon angioplasty (DEBA)Device
Also called Biotronik Passeo Lux 18
DEBA will be performed after pre-dilatation of the target lesion for subjects allocated to the experimental arm.
If there is more than 1 stenosis, only the most severe stenosis will be designated the target lesion and treated according to treatment allocation. All other stenoses will be treated with conventional balloon angioplasty.
High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%).
All patients will be started on dual antiplatelets (aspirin and clopidogrel) for 1 month after intervention, followed by 5 months of aspirin.
Conventional Balloon Angioplasty (CBA)Device
Also called Biotronik Passeo
CBA will be performed for the target lesion for subjects allocated to the active comparator arm.
If there is more than 1 stenosis, only the most severe stenosis will be designated the target lesion and treated according to treatment allocation. All other stenoses will be treated with conventional balloon angioplasty.
High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%).
All patients will be started on dual antiplatelets (aspirin and clopidogrel) for 1 month after intervention, followed by 5 months of aspirin.
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting Balloon Angioplasty (DEBA) | Experimental | After predilatation of the target lesion with conventional balloon angioplasty, a drug-eluting balloon will be inflated to an appropriate inflation pressure, but not exceeding the rated burst pressure of the balloon, for at least a minute. Receives: Device: Drug-eluting balloon angioplasty (DEBA) |
| Conventional Balloon Angioplasty (CBA) | Active comparator | The target lesion will be dilated with a conventional angioplasty balloon to an appropriate inflation pressure, but not exceeding the rated burst pressure of the balloon, for at least a minute. Receives: Device: Conventional Balloon Angioplasty (CBA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fistula used successfully for haemodialysis (FUSH)
FUSH is met if the fistula can be used with two-needle cannulation for two-thirds or more of all dialysis runs for 1 month and if it delivers the prescribed dialysis within the prescribed time frame.
Measured: 3 month
Secondary outcomes (13)
Target lesion anatomic success
Target lesion anatomic success is defined as <30% residual stenosis after angioplasty.
Measured: At the end of index procedure
Time from intervention to first successful haemodialysis with two-needle cannulation
Time from intervention to first successful haemodialysis with two-needle cannulation.
Measured: Up to 12 months
Target lesion percent stenosis at 6-month fistulogram
Percent stenosis of target lesion at 6-month fistulogram
Measured: At 6 months
Target lesion restenosis rate at 6-month fistulogram
The incidence of >50% stenosis of target lesion at 6-month fistulogram
Measured: At 6 months
Number of repeat interventions to target lesion at 6 months
Number of repeat interventions to target lesion at 6 months
Measured: At 6 months
Number of repeat interventions to target lesion at 12 months
Number of repeat interventions to target lesion at 12 months
Measured: At 12 months
Number of repeat interventions to access circuit at 6 months
Number of repeat interventions to access circuit at 6 months
Measured: At 6 months
Number of repeat interventions to access circuit at 12 months
Number of repeat interventions to access circuit at 12 months
Measured: At 12 months
Post intervention target lesion patency
Interval from intervention to repeat clinically driven intervention to target lesion
Measured: Up to 12 months
Post intervention access circuit primary patency
Primary patency is defined as the interval from balloon angioplasty until the next access thrombosis or repeated intervention to maintain access function, or until access abandonment if no interval intervention. It ends with treatment of a lesion anywhere within the access circuit, from the arterial inflow to the superior vena cava-right atrial junction.
Measured: Up to 12 months
Post intervention access circuit assisted primary patency
Primary assisted patency is defined as the interval from balloon angioplasty until access thrombosis or a surgical intervention that excludes the treated lesion from the access circuit. Examples include percutaneous treatments of either restenosis/occlusion of the previously treated lesion or a new arterial or venous outflow stenosis/occlusion (excluding access thrombosis). It ends with percutaneous thrombolysis/thrombectomy or simple surgical thrombectomy.
Measured: Up to 12 months
Post-intervention access circuit secondary patency
Secondary patency is defined as the interval after balloon angioplasty until the access is surgically declotted, revised or abandoned because of inability to treat the original lesion, choice of surgeon, transplant, loss to follow-up, etc. Examples include thrombolysis and percutaneous thrombectomy, as well as multiple repetitive treatments.
Measured: Up to 12 months
Complication rates
Complications will be classified according to the Society of Interventional Radiology Standards of Practice Committee.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study startJun 2017 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stenosis of Arteriovenous Dialysis FistulaStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Kun Da Zhuang, FRCR, MMed, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068845
- Sponsor's protocol ID
- ACADEMIC_01
- Acronym
- ACADEMIC
- Status last verified
- Apr 2017
- First submitted
- 24 Jan 2017
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther. 2012 Apr;19(2):263-72. doi: 10.1583/11-3690.1.
PubMed 22545894Lai CC, Fang HC, Tseng CJ, Liu CP, Mar GY. Percutaneous angioplasty using a paclitaxel-coated balloon improves target lesion restenosis on inflow lesions of autogenous radiocephalic fistulas: a pilot study. J Vasc Interv Radiol. 2014 Apr;25(4):535-41. doi: 10.1016/j.jvir.2013.12.014. Epub 2014 Feb 12.
PubMed 24529550Manninen HI, Kaukanen E, Makinen K, Karhapaa P. Endovascular salvage of nonmaturing autogenous hemodialysis fistulas: comparison with endovascular therapy of failing mature fistulas. J Vasc Interv Radiol. 2008 Jun;19(6):870-6. doi: 10.1016/j.jvir.2008.02.024. Epub 2008 Apr 10.
PubMed 18503901Shin SW, Do YS, Choo SW, Lieu WC, Choo IW. Salvage of immature arteriovenous fistulas with percutaneous transluminal angioplasty. Cardiovasc Intervent Radiol. 2005 Jul-Aug;28(4):434-8. doi: 10.1007/s00270-003-0211-x.
PubMed 16001144
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
- ClinicalTrials.gov ID
- NCT03068845
- Acronym / sponsor ID
- ACADEMIC / ACADEMIC_01
- Keywords
- non-maturing arteriovenous fistula, stenosis of arteriovenous fistula, drug-eluting balloon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Singapore Clinical Research Institute
- Study start
- Jun 2017 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 3 Mar 2017 (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.
The purpose of this randomised clinical trial is to evaluate the efficacy of drug-eluting balloon compared to conventional balloon in balloon-assisted maturation of non-maturing arteriovenous fistula in adult renal failure patients.
Detailed description
This is a single-centre study, where a total of 124 subjects with non-maturing arteriovenous fistula will be randomised (1:1) to either experimental or active comparator arm. Randomisation will be stratified by location of arteriovenous fistula (above versus below elbow).
Each subject will undergo fistulogram in order to assess eligibility criteria. In the event that there is more than 1 eligible stenosis, the most severe stenosis will be considered the target (study) lesion. All other lesions will be treated in the conventional manner. No coil embolisation of collaterals will be performed in the index treatment.
If the subject is allocated to the experimental arm, the target lesion will be treated with pre-dilatation with a conventional balloon before application of the drug-eluting ballon.
If the subject is allocated to the active comparator arm, the target lesion will be treated with a conventional balloon.
High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%).
All subjects will be prescribed 1 month of dual antiplatelets (aspirin and clopidogrel), followed by 5 months of aspirin.
The duration of the study is 12 months. Follow up visits include:
- Two-weekly follow up visits in the first 3 months after intervention until the patient is deemed ready for trial cannulation.
- At 3 months after intervention to assess primary outcome.
- At 6 months after intervention for a fistulogram
- At 12 months after intervention for study closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting Balloon Angioplasty (DEBA) | Experimental | Device: Drug-eluting balloon angioplasty (DEBA)After predilatation of the target lesion with conventional balloon angioplasty, a drug-eluting balloon will be inflated to an appropriate inflation pressure, but not exceeding the rated burst pressure of the balloon, for at least a minute. |
| Conventional Balloon Angioplasty (CBA) | Active comparator | Device: Conventional Balloon Angioplasty (CBA)The target lesion will be dilated with a conventional angioplasty balloon to an appropriate inflation pressure, but not exceeding the rated burst pressure of the balloon, for at least a minute. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Non-maturing upper limb arteriovenous fistula (AVF) created 6-24 weeks ago with any one of the following:
- Stenosis (>50%) along AVF circuit from anastomosis up to, but not including, the subclavian vein.
- Successful guidewire crossing of target lesion.
- >= 21 years old.
- Informed consent given.
Key exclusion criteria (14 listed)
- Thrombosed non-maturing AVF
- Target lesion is longer than 8 cm
- Previous endovascular therapy for non-maturation of the trial AVF
- Baseline systolic blood pressure less than 100 mmHg
- Non-maturing AVF is not planned to be used for dialysis in the immediate future (e.g. chronic kidney disease not requiring haemodialysis yet)
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 |
|---|---|---|
| Drug-eluting balloon angioplasty (DEBA)Also: Biotronik Passeo Lux 18DEBA will be performed after pre-dilatation of the target lesion for subjects allocated to the experimental arm. If there is more than 1 stenosis, only the most severe stenosis will be designated the target lesion and treated according to treatment allocation. All other stenoses will be treated with conventional balloon angioplasty. High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%). All patients will be started on dual antiplatelets (aspirin and clopidogrel) for 1 month after intervention, followed by 5 months of aspirin. | Device | Drug-eluting Balloon Angioplasty (DEBA) |
| Conventional Balloon Angioplasty (CBA)Also: Biotronik PasseoCBA will be performed for the target lesion for subjects allocated to the active comparator arm. If there is more than 1 stenosis, only the most severe stenosis will be designated the target lesion and treated according to treatment allocation. All other stenoses will be treated with conventional balloon angioplasty. High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%). All patients will be started on dual antiplatelets (aspirin and clopidogrel) for 1 month after intervention, followed by 5 months of aspirin. | Device | Conventional Balloon Angioplasty (CBA) |
Primary outcome
Fistula used successfully for haemodialysis (FUSH)
Time frame: 3 month
FUSH is met if the fistula can be used with two-needle cannulation for two-thirds or more of all dialysis runs for 1 month and if it delivers the prescribed dialysis within the prescribed time frame.
13 secondary outcomes
Target lesion anatomic success
Time frame: At the end of index procedure
Time from intervention to first successful haemodialysis with two-needle cannulation
Time frame: Up to 12 months
Target lesion percent stenosis at 6-month fistulogram
Time frame: At 6 months
Target lesion restenosis rate at 6-month fistulogram
Time frame: At 6 months
Number of repeat interventions to target lesion at 6 months
Time frame: At 6 months
Number of repeat interventions to target lesion at 12 months
Time frame: At 12 months
Number of repeat interventions to access circuit at 6 months
Time frame: At 6 months
Number of repeat interventions to access circuit at 12 months
Time frame: At 12 months
Post intervention target lesion patency
Time frame: Up to 12 months
Post intervention access circuit primary patency
Time frame: Up to 12 months
Post intervention access circuit assisted primary patency
Time frame: Up to 12 months
Post-intervention access circuit secondary patency
Time frame: Up to 12 months
Complication rates
Time frame: At 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Background: PubMed 22545894Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther. 2012 Apr;19(2):263-72. doi: 10.1583/11-3690.1.
- Background: PubMed 24529550Lai CC, Fang HC, Tseng CJ, Liu CP, Mar GY. Percutaneous angioplasty using a paclitaxel-coated balloon improves target lesion restenosis on inflow lesions of autogenous radiocephalic fistulas: a pilot study. J Vasc Interv Radiol. 2014 Apr;25(4):535-41. doi: 10.1016/j.jvir.2013.12.014. Epub 2014 Feb 12.
- Background: PubMed 18503901Manninen HI, Kaukanen E, Makinen K, Karhapaa P. Endovascular salvage of nonmaturing autogenous hemodialysis fistulas: comparison with endovascular therapy of failing mature fistulas. J Vasc Interv Radiol. 2008 Jun;19(6):870-6. doi: 10.1016/j.jvir.2008.02.024. Epub 2008 Apr 10.
- Background: PubMed 16001144Shin SW, Do YS, Choo SW, Lieu WC, Choo IW. Salvage of immature arteriovenous fistulas with percutaneous transluminal angioplasty. Cardiovasc Intervent Radiol. 2005 Jul-Aug;28(4):434-8. doi: 10.1007/s00270-003-0211-x.
- Individual participant dataSharing planned: No
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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.
Kun Da Zhuang, FRCR, MMed principal investigator
Singapore General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Drug-eluting balloon angioplasty (DEBA) and Conventional Balloon Angioplasty (CBA) in people with Stenosis of Arteriovenous Dialysis Fistula, run by Singapore General 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 27 Apr 2017. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Da Zhuang, FRCR, MMed (+65 62223322, zhuang.kun.da@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula used successfully for haemodialysis (FUSH) (time frame: 3 month). 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 NCT03068845, which also lists 4 linked publications.
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 27 Apr 2017.