Drug-Eluting Balloon in Arteriovenous Graft

National Taiwan University Hospital Hsin-Chu Branch

Status: Completed

Conditions: Dialysis; Angioplasty; Kidney Failure, Chronic

Treatments: Device: paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy); Device: Plain Balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT03388892

103-065-F

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Drug-Eluting Balloon

Experimental group

Description:

PTA with DEB at venous anastomotic stenosis of AVG

Treatment:

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

Plain Balloon

Active Comparator group

Description:

PTA with PCB at venous anastomotic stenosis of AVG

Treatment:

Device: Plain Balloon