Kidney Failure, Chronic Clinical Trial
Official title:
A Randomized Controlled Trial of Drug-Eluting Balloon Angioplasty in Venous Anastomotic Stenosis of Dialysis Arteriovenous Graft
Verified date | November 2018 |
Source | National Taiwan University Hospital Hsin-Chu Branch |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 44 |
Est. completion date | November 20, 2018 |
Est. primary completion date | July 25, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital Hsinchu Branch | Hsinchu |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital Hsin-Chu Branch |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Paclitaxel-coated balloon safety | Record complications of paclitaxel-coated balloon such as graft failure and vessel dissection or rupture. | 1 year | |
Primary | patent rate in percentage after PTA | 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. | 1 year | |
Secondary | The incidence of angiography-guided binary restenosis rate (=50% of the diameter of the reference-vessel) | Measure the stenotic percentage every 2 months up to 1 year for angiography | 1 year | |
Secondary | The incidence of IVUS-guided binary restenosis rate (=50% of the diameter of the reference-vessel) | Measure the stenotic percentage 1, 6, 12 months for IVUS | 1 year | |
Secondary | Change of AVG flow in liter per minute | measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA | 1 year | |
Secondary | Change of AVG pressure in mmHg | measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA | 1 year | |
Secondary | Time interval of patent AVG after PTA | Patent AVG was defined as luminal loss less than 50% | 1 year | |
Secondary | The rate of AVG failure at 6 months and 12 months | AVG failure was defined as AVG thrombosis, AVG re-intervention | 1 year |
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