DCB for Dialysis Access Stent Graft Restenosis
- Conditions
- Stent-Graft RestenosisDrug-coated BalloonHemodialysis Access Failure (Disorder)Arteriovenous Graft
- Interventions
- Device: DCB (paclitaxel-coated balloon)Device: Regular balloon
- Registration Number
- NCT03360279
- Lead Sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DCB (paclitaxel-coated balloon) DCB (paclitaxel-coated balloon) Use DCB (paclitaxel-coated balloon) to perform additional balloon angioplasty. Regular balloon Regular balloon Use the regular balloon to perform standard balloon angioplasty.
- Primary Outcome Measures
Name Time Method Late luminal loss 0, 1, and 3 months The late luminal loss found by IVUS on follow-up in comparison to index procedure.
- Secondary Outcome Measures
Name Time Method minimal luminal area and diameter 0, 1, and 3 months Done by IVUS on follow-up in comparison to index procedure.
repeated intervention 0, 1, and 3 months defined by repeated endovascular balloon angioplasty or endovascular thrombectomy or surgical open thrombectomy.
abandon of AV graft, death 0, 1, and 3 months stopped to use the target AVG or mortality
restenosis rate 0, 1, and 3 months Compare with follow-up angiography.
Trial Locations
- Locations (1)
National Taiwan University Hospital Hsinchu Branch
🇨🇳Hsinchu, Hsinchu City, Taiwan