Drug-Eluting Balloon in Arteriovenous Graft

NCT03388892 | Completed

• 1 other identifier: 103-065-F
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Failure, Chronic; Angioplasty; Dialysis

Keywords

Angioplasty; Drug Eluting Balloon; Arteriovenous Graft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  1 year

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

  1 year

• Change of AVG flow in liter per minute

  1 year

• Change of AVG pressure in mmHg

  1 year

• Time interval of patent AVG after PTA

  1 year

Other Outcomes (1)

• Paclitaxel-coated balloon safety

  1 year

Study Arms (2)

Drug-Eluting Balloon

EXPERIMENTAL

PTA with DEB at venous anastomotic stenosis of AVG

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

Plain Balloon

ACTIVE COMPARATOR

PTA with PCB at venous anastomotic stenosis of AVG

Device: Plain Balloon

Interventions

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.

Drug-Eluting Balloon

Plain Balloon DEVICE

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

Plain Balloon

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead

Study Sites (1)

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Taiwan

Location

Related Publications (1)

• Liao MT, Lee CP, Lin TT, Jong CB, Chen TY, Lin L, Hsieh MY, Lin MS, Chie WC, Wu CC. A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts. J Vasc Surg. 2020 Jun;71(6):1994-2003. doi: 10.1016/j.jvs.2019.07.090. Epub 2019 Oct 11.

  PMID: 31611105 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: January 3, 2018
• Study Start: January 29, 2015
• Primary Completion: July 25, 2017
• Study Completion: November 20, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Locations

TW (1)