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

Primary Purpose

Dysfunctional Dialysis Arteriovenous Fistula

Status
Terminated
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Vessel preparation with angioplasty
Plain balloon angioplasty
Drug coated balloon angioplasty
Sponsored by
King Abdullah International Medical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysfunctional Dialysis Arteriovenous Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • King ABdulaziz Medical City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug coated balloon angioplasty

Plain balloon angioplasty

Arm Description

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

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

Outcomes

Primary Outcome Measures

AVF circuit patency
Dialysis adequacy to be assessed based on functional criteria

Secondary Outcome Measures

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
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

Full Information

First Posted
June 1, 2017
Last Updated
April 28, 2019
Sponsor
King Abdullah International Medical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03189667
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment and recent concerns of safety of Paclitaxel coated balloons and associated increased risk death
Study Start Date
October 15, 2017 (Actual)
Primary Completion Date
February 5, 2019 (Actual)
Study Completion Date
February 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Abdullah International Medical Research Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysfunctional Dialysis Arteriovenous Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open label randomized clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug coated balloon angioplasty
Arm Type
Experimental
Arm Description
Vessel preparation with Pre dilatation Vessel treatment with Drug-coated balloon
Arm Title
Plain balloon angioplasty
Arm Type
Active Comparator
Arm Description
Vessel preparation with Pre dilatation Vessel treatment with additional Plain balloon angioplasty:
Intervention Type
Device
Intervention Name(s)
Vessel preparation with angioplasty
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Plain balloon angioplasty
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Drug coated balloon angioplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
AVF circuit patency
Description
Dialysis adequacy to be assessed based on functional criteria
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Technical success
Description
<30% residual stenosis without postdilation
Time Frame
intra procedural
Title
Access circuit dysfunction free survival
Description
Time to event based on functional criteria
Time Frame
12 month
Title
Target lesion restenosis free survival
Description
Time to event in case of new lesion causes circuit dysfunction
Time Frame
12 month
Title
Number of participants with treatment-related adverse events
Description
Number of participants with treatment-related adverse events as assessed by the Society of Interventional Radiology Clinical Practice Guidelines
Time Frame
12 month following the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Arabi, MD
Organizational Affiliation
King Abdulaziz Medical City
Official's Role
Principal Investigator
Facility Information:
Facility Name
King ABdulaziz Medical City
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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