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

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

Study Overview

• Status: Terminated
• Conditions: Dysfunctional Dialysis Arteriovenous Fistula
• Intervention / Treatment: Device: Vessel preparation with angioplasty; Device: Drug coated balloon angioplasty; Device: Plain balloon angioplasty

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11426
    • King Abdulaziz Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug coated balloon angioplasty; Vessel preparation with Pre dilatation; Vessel treatment with Drug-coated balloon	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.; Device: 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.
Active Comparator: Plain balloon angioplasty; Vessel preparation with Pre dilatation; Vessel treatment with additional Plain balloon angioplasty:	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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AVF circuit patency	Dialysis adequacy to be assessed based on functional criteria	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	<30% residual stenosis without postdilation	intra procedural
Access circuit dysfunction free survival	Time to event based on functional criteria	12 month
Target lesion restenosis free survival	Time to event in case of new lesion causes circuit dysfunction	12 month
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

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Investigators: Principal Investigator: Mohammad Arabi, MD, King Abdulaziz Medical City

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Actual): February 5, 2019
• Study Completion (Actual): February 5, 2019

Study Registration Dates

• First Submitted: June 1, 2017
• First Submitted That Met QC Criteria: June 15, 2017
• First Posted (Actual): June 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 28, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: RC16/035/R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes