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Drug-Eluting Balloon in Arteriovenous Graft

Primary Purpose

Kidney Failure, Chronic, Angioplasty, Dialysis

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)

Plain Balloon

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Angioplasty, Drug Eluting Balloon, Arteriovenous Graft

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged 18 to 90 years
Patients under hemodialysis via prosthetic arteriovenous graft in the arm
Vascular access was created for more than 30 days and used at least one successful session
Clinical failure for hemodialysis due to higher venous pressure or lower arterial flow
Angiography proved venous anastomotic stenosis ≥50% (the entire lesion of venous anastomotic stenosis will be extended into AVG no more than 2cm and naive vein no more than 7 cm). There was no other obvious stenosis.
Reference diameter of venous anastomosis within 7 mm

Exclusion Criteria:

Patient could not write informed consent
Being unwilling or unable to return for follow-up visits or reason to believe that adherence to follow-up visits would be irregular
Current or scheduled enrollment in other, conflicting studies.
Acute thrombosis in the past 3 months
Central venous stenosis
Concomitant disease (e.g., terminal cancer) or other medical condition likely to result in death within 6 months
A blood coagulation disorder
Sepsis or infected arteriovenous access graft
A contraindication to the use of contrast medium
Pregnancy

Sites / Locations

National Taiwan University Hospital Hsinchu Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug-Eluting Balloon

Plain Balloon

Arm Description

PTA with DEB at venous anastomotic stenosis of AVG

PTA with PCB at venous anastomotic stenosis of AVG

Outcomes

Primary Outcome Measures

patent rate in percentage after PTA

Late luminal loss in patients was evaluated by quantitative angiography after PTA and intravascular ultrasound (IVUS) up to 12 months after PTA. Late luminal loss is defined as the difference between the minimal lumen diameter in percentage and the late luminal loss less than 50% was defined as patency.

Secondary Outcome Measures

The incidence of angiography-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)

Measure the stenotic percentage every 2 months up to 1 year for angiography

The incidence of IVUS-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)

Measure the stenotic percentage 1, 6, 12 months for IVUS

Change of AVG flow in liter per minute

measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA

Change of AVG pressure in mmHg

measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA

Time interval of patent AVG after PTA

Patent AVG was defined as luminal loss less than 50%

The rate of AVG failure at 6 months and 12 months

AVG failure was defined as AVG thrombosis, AVG re-intervention

Full Information

NCT ID

NCT03388892

First Posted

December 2, 2015

Last Updated

November 21, 2018

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

1. Study Identification

Unique Protocol Identification Number

NCT03388892

Brief Title

Drug-Eluting Balloon in Arteriovenous Graft

Official Title

A Randomized Controlled Trial of Drug-Eluting Balloon Angioplasty in Venous Anastomotic Stenosis of Dialysis Arteriovenous Graft

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

January 29, 2015 (Actual)

Primary Completion Date

July 25, 2017 (Actual)

Study Completion Date

November 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital Hsin-Chu Branch

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The investigators' study aims is to evaluate the safety and efficacy of percutaneous transluminal angioplasty (PTA) with paclitaxel-coated balloon (PCB) at venous anastomotic stenosis of arteriovenous graft (AVG) in patients with hemodialysis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Chronic, Angioplasty, Dialysis

Keywords

Angioplasty, Drug Eluting Balloon, Arteriovenous Graft

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug-Eluting Balloon

Arm Type

Experimental

Arm Description

PTA with DEB at venous anastomotic stenosis of AVG

Arm Title

Plain Balloon

Arm Type

Active Comparator

Arm Description

PTA with PCB at venous anastomotic stenosis of AVG

Intervention Type

Device

Intervention Name(s)

paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)

Intervention Description

Arteriovenous graft (AVG) dysfunction or acute thrombosis is mainly caused by neointimal hyperplasia. Although endovascular intervention, such as percutaneous transluminal angioplasty (PTA), catheter-based directed thrombolysis with urokinase, mechanical thrombectomy with percutaneous thrombolytic device or even if graft stenting, can salvage the hemodialysis access, the long-term primary and secondary patent rate don't improve due to repeated restenosis from neointimal hyperplasia. Drug eluting balloon is used in reducing neointimal hypoplasia in patients with coronary in-stent restenosis and it's also effective in restenosis of peripheral arterial diseases. It's reasonable to hypothesize that PTA with PCB at venous anastomotic stenosis of AVG could prolong the patency and reduce the acute thrombosis rate.

Intervention Type

Device

Intervention Name(s)

Plain Balloon

Intervention Description

Traditional Plain Balloon was used to dilate the venous anastomotic stenosis of arteriovenous graft (AVG) as the usual intervention

Primary Outcome Measure Information:

Title

patent rate in percentage after PTA

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

The incidence of angiography-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)

Description

Measure the stenotic percentage every 2 months up to 1 year for angiography

Time Frame

1 year

Title

The incidence of IVUS-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)

Description

Measure the stenotic percentage 1, 6, 12 months for IVUS

Time Frame

1 year

Title

Change of AVG flow in liter per minute

Description

measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA

Time Frame

1 year

Title

Change of AVG pressure in mmHg

Description

measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA

Time Frame

1 year

Title

Time interval of patent AVG after PTA

Description

Patent AVG was defined as luminal loss less than 50%

Time Frame

1 year

Title

The rate of AVG failure at 6 months and 12 months

Description

AVG failure was defined as AVG thrombosis, AVG re-intervention

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Paclitaxel-coated balloon safety

Description

Record complications of paclitaxel-coated balloon such as graft failure and vessel dissection or rupture.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 18 to 90 years Patients under hemodialysis via prosthetic arteriovenous graft in the arm Vascular access was created for more than 30 days and used at least one successful session Clinical failure for hemodialysis due to higher venous pressure or lower arterial flow Angiography proved venous anastomotic stenosis ≥50% (the entire lesion of venous anastomotic stenosis will be extended into AVG no more than 2cm and naive vein no more than 7 cm). There was no other obvious stenosis. Reference diameter of venous anastomosis within 7 mm Exclusion Criteria: Patient could not write informed consent Being unwilling or unable to return for follow-up visits or reason to believe that adherence to follow-up visits would be irregular Current or scheduled enrollment in other, conflicting studies. Acute thrombosis in the past 3 months Central venous stenosis Concomitant disease (e.g., terminal cancer) or other medical condition likely to result in death within 6 months A blood coagulation disorder Sepsis or infected arteriovenous access graft A contraindication to the use of contrast medium Pregnancy

Facility Information:

Facility Name

National Taiwan University Hospital Hsinchu Branch

City

Hsinchu

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

31611105

Citation

Liao MT, Lee CP, Lin TT, Jong CB, Chen TY, Lin L, Hsieh MY, Lin MS, Chie WC, Wu CC. A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts. J Vasc Surg. 2020 Jun;71(6):1994-2003. doi: 10.1016/j.jvs.2019.07.090. Epub 2019 Oct 11.

Results Reference

derived

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Drug-Eluting Balloon in Arteriovenous Graft

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