Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-30

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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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:

1. Two-weekly follow up visits in the first 3 months after intervention until the patient is deemed ready for trial cannulation.
2. At 3 months after intervention to assess primary outcome.
3. At 6 months after intervention for a fistulogram
4. At 12 months after intervention for study closure.

Conditions

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Stenosis of Arteriovenous Dialysis Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Drug-eluting balloon angioplasty (DEBA)

Intervention Type DEVICE

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)

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.

Group Type ACTIVE_COMPARATOR

Conventional Balloon Angioplasty (CBA)

Intervention Type DEVICE

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.

Interventions

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Drug-eluting balloon angioplasty (DEBA)

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

Conventional Balloon Angioplasty (CBA)

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.

Intervention Type DEVICE

Other Intervention Names

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Biotronik Passeo Lux 18 Biotronik Passeo

Eligibility Criteria

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Inclusion Criteria

1. Non-maturing upper limb arteriovenous fistula (AVF) created 6-24 weeks ago with any one of the following:

1. Non-maturing on physical examination, or
2. Failed initial cannulation, or
3. Failure to achieve prescribed dialysis within prescribed time frame.
2. Stenosis (\>50%) along AVF circuit from anastomosis up to, but not including, the subclavian vein.
3. Successful guidewire crossing of target lesion.
4. \>= 21 years old.
5. Informed consent given.
6. Patient willing and able to return for 3 month, 6 month fistulogram and 12 month clinic follow up.

Exclusion Criteria

1. Thrombosed non-maturing AVF
2. Target lesion is longer than 8 cm
3. Previous endovascular therapy for non-maturation of the trial AVF
4. Baseline systolic blood pressure less than 100 mmHg
5. Non-maturing AVF is not planned to be used for dialysis in the immediate future (e.g. chronic kidney disease not requiring haemodialysis yet)
6. Coagulopathy (prothrombin time or activated partial thromboplastin time \>1.5 times the median of normal range) that cannot be managed adequately with periprocedural transfusion
7. Thrombocytopenia (platelet count \<50,000 /μL) that cannot be managed adequately with periprocedural transfusion
8. Known allergy to iodinated contrast that cannot be managed adequately with pre-procedure medication
9. Allergy / contraindication to dual anti-platelet therapy (aspirin and clopidogrel or ticlopidine) or paclitaxel
10. Acute infection over proposed puncture site
11. Women who are breastfeeding, pregnant or planning on becoming pregnant during study.
12. Men who are planning on fathering children during the study.
13. Participant with medical conditions which in the opinion of the investigator may cause non-compliance with protocol.
14. Currently participating in an investigational drug, biologic or device trial that may have an impact on the AVF or previous enrollment in this study.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No