Drug-Eluting Balloon in Arteriovenous Graft

Study Overview
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Brief Summary
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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

Official Title
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A Randomized Controlled Trial of Drug-Eluting Balloon Angioplasty in Venous Anastomotic Stenosis of Dialysis Arteriovenous Graft

Conditions
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Kidney Failure, Chronic, Angioplasty, Dialysis

Intervention / Treatment
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* Device: paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)
* Device: Plain Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug-Eluting Balloon<br>PTA with DEB at venous anastomotic stenosis of AVG | Device: paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)<br>* 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.<br>|
| Active Comparator: Plain Balloon<br>PTA with PCB at venous anastomotic stenosis of AVG | Device: Plain Balloon<br>* Traditional Plain Balloon was used to dilate the venous anastomotic stenosis of arteriovenous graft (AVG) as the usual intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Time interval of patent AVG after PTA | Patent AVG was defined as luminal loss less than 50% | 1 year | 
| The rate of AVG failure at 6 months and 12 months | AVG failure was defined as AVG thrombosis, AVG re-intervention | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angioplasty, Drug Eluting Balloon, Arteriovenous Graft