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Completed

NCT Number: NCT03388892

Drug-Eluting Balloon in Arteriovenous Graft

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

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Key information

Conditions

Kidney Failure, Chronic Angioplasty Chronic Disease Dialysis Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)

Device

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.

Plain Balloon

Device

Traditional Plain Balloon was used to dilate the venous anastomotic stenosis of arteriovenous graft (AVG) as the usual intervention

Primary outcomes

  1. patent rate in percentage after PTA

    Time frame: 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 outcomes

  1. The incidence of angiography-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)

    Time frame: 1 year

    Measure the stenotic percentage every 2 months up to 1 year for angiography

  2. The incidence of IVUS-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)

    Time frame: 1 year

    Measure the stenotic percentage 1, 6, 12 months for IVUS

  3. Change of AVG flow in liter per minute

    Time frame: 1 year

    measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA

  4. Change of AVG pressure in mmHg

    Time frame: 1 year

    measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA

  5. Time interval of patent AVG after PTA

    Time frame: 1 year

    Patent AVG was defined as luminal loss less than 50%

  6. The rate of AVG failure at 6 months and 12 months

    Time frame: 1 year

    AVG failure was defined as AVG thrombosis, AVG re-intervention

Other outcomes

  1. Paclitaxel-coated balloon safety

    Time frame: 1 year

    Record complications of paclitaxel-coated balloon such as graft failure and vessel dissection or rupture.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital Hsin-Chu Branch

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jan 3, 2018
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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