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

Dysfunctional Dialysis Arteriovenous Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03189667
• Other study ID #: RC16/035/R
• Status: Terminated
• Phase: N/A
• Start date: October 15, 2017
• Est. completion date: February 5, 2019

Study information

• Verified date: April 2019
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: February 5, 2019
• Est. primary completion date: February 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Dysfunctional Dialysis Arteriovenous Fistula
• Fistula

Intervention

Device:
• Vessel preparation with angioplasty
Vessel preparation with Pre dilatation: All lesions to be predilated with high pressure balloons until waist is obliterated. At least two minutes dilatation. Balloon sizing: not to exceed the average diameter of adjacent normal appearing non-aneurysmal segments by more than 25%. Multiple lesions: To be treated with single balloon if possible. To be treated with multiple inflation if cannot be covered with single balloon.
• Plain balloon angioplasty
Plain balloon angioplasty Vessel treatment with additional Plain balloon angioplasty: Inflation to nominal pressure for at least 1 minute. Balloon size: similar to predilation balloon.
• Drug coated balloon angioplasty
Lutonix® Drug Coated Balloon: The balloon is coated with a specialized formulation that includes the drug, paclitaxel. The paclitaxel coating is evenly distributed across the working length of the balloon at a surface concentration of 2 µg/mm2. The key functional characteristic of the formulation is to allow for release of paclitaxel to the tissue of the vascular wall during inflation. Inflation to nominal pressure for at least 1 minute. Balloon size: similar to the predilation balloon. New drug coated balloon will be required for each lesion.

Locations

Country	Name	City	State
Saudi Arabia	King ABdulaziz Medical City	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AVF circuit patency	Dialysis adequacy to be assessed based on functional criteria	12 month
Secondary	Technical success	<30% residual stenosis without postdilation	intra procedural
Secondary	Access circuit dysfunction free survival	Time to event based on functional criteria	12 month
Secondary	Target lesion restenosis free survival	Time to event in case of new lesion causes circuit dysfunction	12 month
Secondary	Number of participants with treatment-related adverse events	Number of participants with treatment-related adverse events as assessed by the Society of Interventional Radiology Clinical Practice Guidelines	12 month following the procedure