Clinical trial NCT03388892: 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
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Failure, Chronic
Angioplasty
Dialysis
Keywords: Angioplasty
Drug Eluting Balloon
Arteriovenous Graft
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: patent rate in percentage after PTA
timeFrame: 1 year
Secondary outcomes:
measure: The incidence of angiography-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)
timeFrame: 1 year
measure: The incidence of IVUS-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)
timeFrame: 1 year
measure: Change of AVG flow in liter per minute
timeFrame: 1 year
measure: Change of AVG pressure in mmHg
timeFrame: 1 year
measure: Time interval of patent AVG after PTA
timeFrame: 1 year
measure: The rate of AVG failure at 6 months and 12 months
timeFrame: 1 year
Other outcomes:
measure: Paclitaxel-coated balloon safety
timeFrame: 1 year
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsinchu Branch
Study officials:
References:
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.