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

King Abdullah International Medical Research Center

Status: Terminated

Conditions: Dysfunctional Dialysis Arteriovenous Fistula

Treatments: Device: Plain balloon angioplasty; Device: Drug coated balloon angioplasty; Device: Vessel preparation with angioplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03189667

RC16/035/R

Details and patient eligibility

About

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

Full 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)

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Drug coated balloon angioplasty

Experimental group

Description:

* Vessel preparation with Pre dilatation * Vessel treatment with Drug-coated balloon

Treatment:

Device: Vessel preparation with angioplasty

Device: Drug coated balloon angioplasty

Plain balloon angioplasty

Active Comparator group

Description:

* Vessel preparation with Pre dilatation * Vessel treatment with additional Plain balloon angioplasty:

Treatment:

Device: Plain balloon angioplasty

Device: Vessel preparation with angioplasty