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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03388892
Other study ID # 103-065-F
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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