Clinical trial NCT03360279: DCB for Dialysis Access Stent Graft Restenosis
Official title: A Randomized Trial Comparing Drug-coated Balloon and Regular Balloon for Dialysis Access Stent Graft Restenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis Access Failure (Disorder)
Stent-Graft Restenosis
Arteriovenous Graft
Drug-coated Balloon
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, there is no data regarding treatment of stent graft restenosis in AVG. This randomized trial is designed to compare the efficacy and safety of drug-coated balloon (DCB) versus regular balloon in AVG stent graft restenosis.

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 stenosis to improve long-term patency rate. However, after stent graft implementation, the effective treatment for restenosis in a stent graft is still unknown. This randomized trial is designed to evaluate the efficacy and safety of drug-coated balloon versus regular balloon for in-stent restenosis in stent graft. The investigators plan to enroll 40 patients who presented with prosthetic AVG in-stent restenosis, and then to evaluate the restenosis lesions by intravascular ultrasound. Patients will be randomized into two groups of treatment: drug-coated balloon angioplasty or regular balloon angioplasty.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Late luminal loss
timeFrame: 0, 1, and 3 months
Secondary outcomes:
measure: minimal luminal area and diameter
timeFrame: 0, 1, and 3 months
measure: restenosis rate
timeFrame: 0, 1, and 3 months
measure: repeated intervention
timeFrame: 0, 1, and 3 months
measure: abandon of AV graft, death
timeFrame: 0, 1, and 3 months
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsinchu Branch
state: Hsinchu City
Study officials:
affiliation: National Taiwan University Hospital Hsin-Chu Branch
name: Mu-Yang Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References: