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Clinical Trials/NCT03189667
NCT03189667TerminatedNot Applicable

Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula

King Abdullah International Medical Research Center2 sites in 1 country23 target enrollmentStarted: October 15, 2017Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
23
Locations
2
Primary Endpoint
AVF circuit patency
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis arteriovenous fistulas (AVFs).

Detailed Description

Objectives of the Study:

Hypothesis: Drug-coated balloons improve functional and patency outcomes of failing/dysfunctional hemodialysis fistulas compared to plain uncoated balloons

Aim of the Study:

Compare the effectiveness of drug-coated balloons to plain balloon angioplasty in reducing stenosis rates in dialysis AVFs.

Specific Objectives:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Inclusion criteria
  • •>18 year old
  • •Dysfunctional dialysis fistula
  • •Radiocephalic
  • •Brachiocephalic
  • •Brachiobasilic
  • •Clinical criteria for diagnosis of dysfunctional fistula:
  • •Swelling of the fistula limb
  • •Prolonged bleeding after withdrawing access needles
  • •Abnormal pulsations or weak thrill.
  • •Functional criteria for the diagnosis of dysfunctional criteria:
  • •Arteriovenous fistula is unable to deliver dialysis blood flow (Qb) of equal to or more than 300 ml/min and/or access recirculation of more than 10% on at least two occasions,
  • •A rising trend of venous pressure or excessive negative arterial pressure, and/or unable to deliver a Kt/v of 1.2 or more.
  • •Non-thrombosed

Exclusion Criteria

  • •Dysfunctional arteriovenous (AV) grafts
  • •Thrombosed fistulas
  • •Intra-stent stenosis
  • •Stenoses not responding to balloon angioplasty and requiring stenting.
  • •Stenosis less than 50%
  • •Surgical intervention that excludes the treatment segment from the access circuit
  • •Systemic or local (to the fistula) infection treated for less than 10 days prior to the study procedure
  • •Location of isolated stenosis central to the thoracic inlet.
  • •Women who are breastfeeding, pregnant or are intending to become pregnant
  • •Known hypersensitivity or contraindication to contrast medium which cannot be adequately premeditated.
  • •Sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel

Arms & Interventions

Drug coated balloon angioplasty

Experimental
  • Vessel preparation with Pre dilatation
  • Vessel treatment with Drug-coated balloon

Intervention: Vessel preparation with angioplasty (Device)

Drug coated balloon angioplasty

Experimental
  • Vessel preparation with Pre dilatation
  • Vessel treatment with Drug-coated balloon

Intervention: Drug coated balloon angioplasty (Device)

Plain balloon angioplasty

Active Comparator
  • Vessel preparation with Pre dilatation
  • Vessel treatment with additional Plain balloon angioplasty:

Intervention: Vessel preparation with angioplasty (Device)

Plain balloon angioplasty

Active Comparator
  • Vessel preparation with Pre dilatation
  • Vessel treatment with additional Plain balloon angioplasty:

Intervention: Plain balloon angioplasty (Device)

Outcomes

Primary Outcomes

AVF circuit patency

Time Frame: 12 month

Dialysis adequacy to be assessed based on functional criteria

Secondary Outcomes

  • Technical success(intra procedural)
  • Target lesion restenosis free survival(12 month)
  • Access circuit dysfunction free survival(12 month)
  • Number of participants with treatment-related adverse events(12 month following the procedure)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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