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

National Taiwan University Hospital Hsin-Chu Branch1 site in 1 country44 target enrollmentJanuary 29, 2015

ConditionsKidney Failure, Chronic Angioplasty Dialysis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Kidney Failure, Chronic
Sponsor: National Taiwan University Hospital Hsin-Chu Branch
Enrollment: 44
Locations: 1
Primary Endpoint: patent rate in percentage after PTA
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 29, 2015

End Date

November 20, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

National Taiwan University Hospital Hsin-Chu Branch

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

patent rate in percentage after PTA

Time Frame: 1 year

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 Outcomes

The incidence of IVUS-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)(1 year)
Time interval of patent AVG after PTA(1 year)
The rate of AVG failure at 6 months and 12 months(1 year)
The incidence of angiography-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)(1 year)
Change of AVG flow in liter per minute(1 year)
Change of AVG pressure in mmHg(1 year)