Drug-Eluting Balloon in Arteriovenous Graft

Not Applicable

Completed

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

• Registration Number: NCT03388892
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-29
• Study First Submitted: 2015-12-02
• Primary Completion: 2017-07-25
• Study First Submitted QC: 2018-01-02
• Study First Posted: 2018-01-03
• Status Verified: 2018-11
• Study Completion: 2018-11-20
• Last Update Submitted: 2018-11-21
• Last Update Posted: 2018-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug-Eluting Balloon	paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)	PTA with DEB at venous anastomotic stenosis of AVG
Plain Balloon	Plain Balloon	PTA with PCB at venous anastomotic stenosis of AVG

Primary Outcome Measures

Name	Time	Method
patent rate in percentage after PTA	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 Outcome Measures

Name	Time	Method
The incidence of IVUS-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)	1 year	Measure the stenotic percentage 1, 6, 12 months for IVUS
Time interval of patent AVG after PTA	1 year	Patent AVG was defined as luminal loss less than 50%
The rate of AVG failure at 6 months and 12 months	1 year	AVG failure was defined as AVG thrombosis, AVG re-intervention
The incidence of angiography-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)	1 year	Measure the stenotic percentage every 2 months up to 1 year for angiography
Change of AVG flow in liter per minute	1 year	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	1 year	measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA

Trial Locations

Locations (1)

National Taiwan University Hospital Hsinchu Branch; 🇨🇳 Hsinchu, Taiwan