Drug-Eluting Balloon in Arteriovenous Graft

NCT ID: NCT03388892

Last Updated: 2018-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-29
• Study Completion Date: 2018-11-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Drug-Eluting Balloon

PTA with DEB at venous anastomotic stenosis of AVG

Group Type: EXPERIMENTAL

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

Intervention Type: 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

PTA with PCB at venous anastomotic stenosis of AVG

Group Type: ACTIVE_COMPARATOR

Plain Balloon

Intervention Type: DEVICE

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

Interventions

paclitaxel-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.

Intervention Type: DEVICE

Plain Balloon

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital Hsinchu Branch

Hsinchu, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 31611105 (View on PubMed)

Other Identifiers

103-065-F

Identifier Type: -

Identifier Source: org_study_id