Back to resultsArteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial (ACADEMIC)
Primary Purpose
Stenosis of Arteriovenous Dialysis Fistula
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Drug-eluting balloon angioplasty (DEBA)
Conventional Balloon Angioplasty (CBA)
Sponsored by
About this trial
This is an interventional treatment trial for Stenosis of Arteriovenous Dialysis Fistula focused on measuring non-maturing arteriovenous fistula, stenosis of arteriovenous fistula, drug-eluting balloon
Eligibility Criteria
Inclusion Criteria:
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.
- >= 21 years old.
- Informed consent given.
- Patient willing and able to return for 3 month, 6 month fistulogram and 12 month clinic follow up.
Exclusion Criteria:
- 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
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Drug-eluting Balloon Angioplasty (DEBA)
Conventional Balloon Angioplasty (CBA)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Target lesion anatomic success
Target lesion anatomic success is defined as <30% residual stenosis after angioplasty.
Time from intervention to first successful haemodialysis with two-needle cannulation
Time from intervention to first successful haemodialysis with two-needle cannulation.
Target lesion percent stenosis at 6-month fistulogram
Percent stenosis of target lesion at 6-month fistulogram
Target lesion restenosis rate at 6-month fistulogram
The incidence of >50% stenosis of target lesion at 6-month fistulogram
Number of repeat interventions to target lesion at 6 months
Number of repeat interventions to target lesion at 6 months
Number of repeat interventions to target lesion at 12 months
Number of repeat interventions to target lesion at 12 months
Number of repeat interventions to access circuit at 6 months
Number of repeat interventions to access circuit at 6 months
Number of repeat interventions to access circuit at 12 months
Number of repeat interventions to access circuit at 12 months
Post intervention target lesion patency
Interval from intervention to repeat clinically driven intervention to target lesion
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.
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.
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.
Complication rates
Complications will be classified according to the Society of Interventional Radiology Standards of Practice Committee.
Full Information
NCT ID
NCT03068845
First Posted
January 24, 2017
Last Updated
April 25, 2017
Sponsor
Singapore General Hospital
Collaborators
Singapore Clinical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03068845
Brief Title
Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
Acronym
ACADEMIC
Official Title
Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Singapore Clinical Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis of Arteriovenous Dialysis Fistula
Keywords
non-maturing arteriovenous fistula, stenosis of arteriovenous fistula, drug-eluting balloon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The participants, referring physicians, outcomes assessors and data analysis team will be masked. The procedurist will not be masked since it is not possible to perform the procedure without masking. The procedurist will not be involved in outcomes assessment.
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug-eluting Balloon Angioplasty (DEBA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Balloon Angioplasty (CBA)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Drug-eluting balloon angioplasty (DEBA)
Other Intervention Name(s)
Biotronik Passeo Lux 18
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional Balloon Angioplasty (CBA)
Other Intervention Name(s)
Biotronik Passeo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fistula used successfully for haemodialysis (FUSH)
Description
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.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Target lesion anatomic success
Description
Target lesion anatomic success is defined as <30% residual stenosis after angioplasty.
Time Frame
At the end of index procedure
Title
Time from intervention to first successful haemodialysis with two-needle cannulation
Description
Time from intervention to first successful haemodialysis with two-needle cannulation.
Time Frame
Up to 12 months
Title
Target lesion percent stenosis at 6-month fistulogram
Description
Percent stenosis of target lesion at 6-month fistulogram
Time Frame
At 6 months
Title
Target lesion restenosis rate at 6-month fistulogram
Description
The incidence of >50% stenosis of target lesion at 6-month fistulogram
Time Frame
At 6 months
Title
Number of repeat interventions to target lesion at 6 months
Description
Number of repeat interventions to target lesion at 6 months
Time Frame
At 6 months
Title
Number of repeat interventions to target lesion at 12 months
Description
Number of repeat interventions to target lesion at 12 months
Time Frame
At 12 months
Title
Number of repeat interventions to access circuit at 6 months
Description
Number of repeat interventions to access circuit at 6 months
Time Frame
At 6 months
Title
Number of repeat interventions to access circuit at 12 months
Description
Number of repeat interventions to access circuit at 12 months
Time Frame
At 12 months
Title
Post intervention target lesion patency
Description
Interval from intervention to repeat clinically driven intervention to target lesion
Time Frame
Up to 12 months
Title
Post intervention access circuit primary patency
Description
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.
Time Frame
Up to 12 months
Title
Post intervention access circuit assisted primary patency
Description
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.
Time Frame
Up to 12 months
Title
Post-intervention access circuit secondary patency
Description
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.
Time Frame
Up to 12 months
Title
Complication rates
Description
Complications will be classified according to the Society of Interventional Radiology Standards of Practice Committee.
Time Frame
At 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
>= 21 years old.
Informed consent given.
Patient willing and able to return for 3 month, 6 month fistulogram and 12 month clinic follow up.
Exclusion Criteria:
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Da Zhuang, FRCR, MMed
Phone
+65 62223322
Email
zhuang.kun.da@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Da Zhuang, FRCR, MMed
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22545894
Citation
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.
Results Reference
background
PubMed Identifier
24529550
Citation
Lai 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.
Results Reference
background
PubMed Identifier
18503901
Citation
Manninen 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.
Results Reference
background
PubMed Identifier
16001144
Citation
Shin 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.
Results Reference
background
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Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
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