Kidney Failure, Chronic, Angioplasty, Dialysis
Conditions
Keywords
Angioplasty, Drug Eluting Balloon, Arteriovenous Graft
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
Interventions
DEVICEpaclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)
Arteriovenous graft (AVG) dysfunction or acute thrombosis is mainly caused by neointimal hyperplasia. Although endovascular intervention, such as percutaneous transluminal angioplasty (PTA), catheter-based directed thrombolysis with urokinase, mechanical thrombectomy with percutaneous thrombolytic device or even if graft stenting, can salvage the hemodialysis access, the long-term primary and secondary patent rate don't improve due to repeated restenosis from neointimal hyperplasia. Drug eluting balloon is used in reducing neointimal hypoplasia in patients with coronary in-stent restenosis and it's also effective in restenosis of peripheral arterial diseases. It's reasonable to hypothesize that PTA with PCB at venous anastomotic stenosis of AVG could prolong the patency and reduce the acute thrombosis rate.
DEVICEPlain Balloon
Traditional Plain Balloon was used to dilate the venous anastomotic stenosis of arteriovenous graft (AVG) as the usual intervention
Sponsors
National Taiwan University Hospital Hsin-Chu Branch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Paclitaxel-coated balloon safety | 1 year | Record complications of paclitaxel-coated balloon such as graft failure and vessel dissection or rupture. |
Countries
Taiwan
Outcome results
None listed