Status:
COMPLETED
Drug-Eluting Balloon in Arteriovenous Graft
Lead Sponsor:
National Taiwan University Hospital Hsin-Chu Branch
Conditions:
Kidney Failure, Chronic
Angioplasty
Eligibility:
All Genders
18-90 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
- Pregnancy
Key Trial Info
Start Date :
January 29 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 20 2018
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT03388892
Start Date
January 29 2015
End Date
November 20 2018
Last Update
November 23 2018
Active Locations (1)
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1
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Taiwan