Drug-Eluting Balloon in Arteriovenous Graft

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

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

Study Overview

• Status: Completed
• Conditions: Kidney Failure, Chronic; Dialysis; Angioplasty
• Intervention / Treatment: Device: paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy); Device: Plain Balloon

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hsinchu, Taiwan
    • National Taiwan University Hospital HsinChu Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 18 to 90 years
2. Patients under hemodialysis via prosthetic arteriovenous graft in the arm
3. Vascular access was created for more than 30 days and used at least one successful session
4. Clinical failure for hemodialysis due to higher venous pressure or lower arterial flow
5. 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.
6. Reference diameter of venous anastomosis within 7 mm

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug-Eluting Balloon; PTA with DEB at venous anastomotic stenosis of AVG	Device: paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy); 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.
Active Comparator: Plain Balloon; PTA with PCB at venous anastomotic stenosis of AVG	Device: Plain Balloon; Traditional Plain Balloon was used to dilate the venous anastomotic stenosis of arteriovenous graft (AVG) as the usual intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
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	1 year
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	1 year
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	1 year
Time interval of patent AVG after PTA	Patent AVG was defined as luminal loss less than 50%	1 year
The rate of AVG failure at 6 months and 12 months	AVG failure was defined as AVG thrombosis, AVG re-intervention	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paclitaxel-coated balloon safety	Record complications of paclitaxel-coated balloon such as graft failure and vessel dissection or rupture.	1 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2015
• Primary Completion (Actual): July 25, 2017
• Study Completion (Actual): November 20, 2018

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: January 2, 2018
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Angioplasty; Arteriovenous Graft; Drug Eluting Balloon
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Renal Insufficiency; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: 103-065-F

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No