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

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ClinicalTrials.gov Identifier: NCT03068845
Recruitment Status : Not yet recruiting
First Posted : March 3, 2017
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
Singapore Clinical Research Institute
Information provided by (Responsible Party):
Singapore General Hospital

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.

Condition or disease Intervention/treatment Phase
Stenosis of Arteriovenous Dialysis Fistula Device: Drug-eluting balloon angioplasty (DEBA) Device: Conventional Balloon Angioplasty (CBA) Phase 3

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:

  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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes 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.
Primary Purpose: Treatment
Official Title: Arteriovenous Fistula: Conventional Angioplasty vs Drug Eluting Balloon-assisted Maturation Intervention Clinical Trial
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty Fistulas

Arm Intervention/treatment
Experimental: 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.
Device: 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.

Other Name: Biotronik Passeo Lux 18

Active Comparator: 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.
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.

Other Name: Biotronik Passeo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Target lesion anatomic success [ Time Frame: At the end of index procedure ]
    Target lesion anatomic success is defined as <30% residual stenosis after angioplasty.

  2. Time from intervention to first successful haemodialysis with two-needle cannulation [ Time Frame: Up to 12 months ]
    Time from intervention to first successful haemodialysis with two-needle cannulation.

  3. Target lesion percent stenosis at 6-month fistulogram [ Time Frame: At 6 months ]
    Percent stenosis of target lesion at 6-month fistulogram

  4. Target lesion restenosis rate at 6-month fistulogram [ Time Frame: At 6 months ]
    The incidence of >50% stenosis of target lesion at 6-month fistulogram

  5. Number of repeat interventions to target lesion at 6 months [ Time Frame: At 6 months ]
    Number of repeat interventions to target lesion at 6 months

  6. Number of repeat interventions to target lesion at 12 months [ Time Frame: At 12 months ]
    Number of repeat interventions to target lesion at 12 months

  7. Number of repeat interventions to access circuit at 6 months [ Time Frame: At 6 months ]
    Number of repeat interventions to access circuit at 6 months

  8. Number of repeat interventions to access circuit at 12 months [ Time Frame: At 12 months ]
    Number of repeat interventions to access circuit at 12 months

  9. Post intervention target lesion patency [ Time Frame: Up to 12 months ]
    Interval from intervention to repeat clinically driven intervention to target lesion

  10. Post intervention access circuit primary patency [ Time Frame: Up to 12 months ]
    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.

  11. Post intervention access circuit assisted primary patency [ Time Frame: Up to 12 months ]
    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.

  12. Post-intervention access circuit secondary patency [ Time Frame: Up to 12 months ]
    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.

  13. Complication rates [ Time Frame: At 12 months ]
    Complications will be classified according to the Society of Interventional Radiology Standards of Practice Committee.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03068845


Contacts
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Contact: Kun Da Zhuang, FRCR, MMed +65 62223322 zhuang.kun.da@singhealth.com.sg

Sponsors and Collaborators
Singapore General Hospital
Singapore Clinical Research Institute
Investigators
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Principal Investigator: Kun Da Zhuang, FRCR, MMed Singapore General Hospital

Publications:
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03068845     History of Changes
Other Study ID Numbers: ACADEMIC_01
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Singapore General Hospital:
non-maturing arteriovenous fistula
stenosis of arteriovenous fistula
drug-eluting balloon
Additional relevant MeSH terms:
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Arteriovenous Fistula
Fistula
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities