Clinical trial NCT03189667: Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula
Official title: Drug Coated Balloons vs Plain Balloons for the Management of Dysfunctional Dialysis Fistula
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dysfunctional Dialysis Arteriovenous Fistula
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized clinical trial
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: AVF circuit patency
timeFrame: 12 month
Secondary outcomes:
measure: Technical success
timeFrame: intra procedural
measure: Access circuit dysfunction free survival
timeFrame: 12 month
measure: Target lesion restenosis free survival
timeFrame: 12 month
measure: Number of participants with treatment-related adverse events
timeFrame: 12 month following the procedure
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King ABdulaziz Medical City
Study officials:
affiliation: King Abdulaziz Medical City
name: Mohammad Arabi, MD
role: PRINCIPAL_INVESTIGATOR
References: