Status:
UNKNOWN
DCB for Dialysis Access Stent Graft Restenosis
Lead Sponsor:
National Taiwan University Hospital Hsin-Chu Branch
Conditions:
Hemodialysis Access Failure (Disorder)
Stent-Graft Restenosis
Eligibility:
All Genders
20-90 years
Phase:
NA
Brief Summary
Recurrent stenosis in hemodialysis access graft (AVG) is difficult to treat. For recurrent stenosis in the anastomotic junction can be treated by stent graft to improve long-term patency. However, the...
Detailed Description
Prosthetic arteriovenous hemodialysis access graft (AVG) has high incidences of venous anastomotic stenosis and access failure. A stent graft can be used in AVG with recurrent venous anastomotic steno...
Eligibility Criteria
Inclusion
- Age of 20 to 90 years on regular hemodialysis at least 3 months
- Had stent graft implemented at dialysis vascular access
- Angiographic evidence of stenosis within the stent graft or less than 2 cm from the stent graft edge
- Clinical evidence of a hemodynamically significant stenosis or thrombosis
- Patient is able to provide written informed consent
Exclusion
- Elbow fracture or any disease involve the elbow joint that prohibits the flexion maneuver.
- Target lesion cannot be crossed by the guide wire.
- Known hypersensitivity to heparin or contrast medium.
- Bleeding diathesis.
- Patients participating in another clinical trial with interfering with this trial in the past three months.
- Untreatable bleeding diathesis.
- Other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patient's life expectancy (less than 3 months).
- Patients unable or unwilling to participate this trial.
- Pregnancy, lactating woman, non-adult, criminals in sentence, psychiatric patients, research staffs or colleagues are prohibited.
Key Trial Info
Start Date :
March 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03360279
Start Date
March 5 2017
End Date
December 31 2019
Last Update
December 4 2017
Active Locations (1)
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1
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Hsinchu City, Taiwan, 300