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

Not Applicable

Terminated

• Conditions: Dysfunctional Dialysis Arteriovenous Fistula
• Interventions: Device: Vessel preparation with angioplasty; Device: Plain balloon angioplasty; Device: Drug coated balloon angioplasty

• Registration Number: NCT03189667
• Lead Sponsor: King Abdullah International Medical Research Center

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:

Primary functional endpoint: Access circuit patency based on functional criteria at 12 month.

Primary safety endpoint: Peri procedural complication rate

Secondary endpoints:

* Technical success (\<30% residual stenosis without postdilation)

* Access circuit dysfunction free survival (Time to event) based on functional criteria

* Target lesion restenosis free survival (Time to event) (in case of new lesion causes circuit dysfunction)

Study Timeline

• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-16
• Study Start: 2017-10-15
• Primary Completion: 2019-02-05
• Study Completion: 2019-02-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-28
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plain balloon angioplasty	Plain balloon angioplasty	* Vessel preparation with Pre dilatation * Vessel treatment with additional Plain balloon angioplasty:
Drug coated balloon angioplasty	Vessel preparation with angioplasty	* Vessel preparation with Pre dilatation * Vessel treatment with Drug-coated balloon
Drug coated balloon angioplasty	Drug coated balloon angioplasty	* Vessel preparation with Pre dilatation * Vessel treatment with Drug-coated balloon
Plain balloon angioplasty	Vessel preparation with angioplasty	* Vessel preparation with Pre dilatation * Vessel treatment with additional Plain balloon angioplasty:

Primary Outcome Measures

Name	Time	Method
AVF circuit patency	12 month	Dialysis adequacy to be assessed based on functional criteria

Secondary Outcome Measures

Name	Time	Method
Target lesion restenosis free survival	12 month	Time to event in case of new lesion causes circuit dysfunction
Technical success	intra procedural	\<30% residual stenosis without postdilation
Access circuit dysfunction free survival	12 month	Time to event based on functional criteria
Number of participants with treatment-related adverse events	12 month following the procedure	Number of participants with treatment-related adverse events as assessed by the Society of Interventional Radiology Clinical Practice Guidelines

Trial Locations

Locations (1)

King ABdulaziz Medical City; 🇸🇦 Riyadh, Saudi Arabia