DCB for Dialysis Access Stent Graft Restenosis

National Taiwan University Hospital Hsin-Chu Branch

Status: Unknown

Conditions: Drug-coated Balloon; Stent-Graft Restenosis; Arteriovenous Graft; Hemodialysis Access Failure (Disorder)

Treatments: Device: DCB (paclitaxel-coated balloon); Device: Regular balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT03360279

105-015-F

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Regular balloon

Active Comparator group

Description:

Use the regular balloon to perform standard balloon angioplasty.

Treatment:

Device: Regular balloon

DCB (paclitaxel-coated balloon)

Active Comparator group

Description:

Use DCB (paclitaxel-coated balloon) to perform additional balloon angioplasty.

Treatment:

Device: DCB (paclitaxel-coated balloon)