Drug-Eluting Balloon in Arteriovenous Graft

Kidney Failure, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388892
• Other study ID #: 103-065-F
• Status: Completed
• Phase: N/A
• Start date: January 29, 2015
• Est. completion date: November 20, 2018

Study information

• Verified date: November 2018
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 20, 2018
• Est. primary completion date: July 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Angioplasty
• Dialysis
• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Hsinchu Branch	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Paclitaxel-coated balloon safety	Record complications of paclitaxel-coated balloon such as graft failure and vessel dissection or rupture.	1 year
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time interval of patent AVG after PTA	Patent AVG was defined as luminal loss less than 50%	1 year
Secondary	The rate of AVG failure at 6 months and 12 months	AVG failure was defined as AVG thrombosis, AVG re-intervention	1 year