Arteriovenous Graft Clinical Trial
Official title:
A Randomized Trial Comparing Drug-coated Balloon and Regular Balloon for Dialysis Access Stent Graft Restenosis
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital Hsinchu Branch | Hsinchu | Hsinchu City |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital Hsin-Chu Branch |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Late luminal loss | The late luminal loss found by IVUS on follow-up in comparison to index procedure. | 0, 1, and 3 months | |
Secondary | minimal luminal area and diameter | Done by IVUS on follow-up in comparison to index procedure. | 0, 1, and 3 months | |
Secondary | restenosis rate | Compare with follow-up angiography. | 0, 1, and 3 months | |
Secondary | repeated intervention | defined by repeated endovascular balloon angioplasty or endovascular thrombectomy or surgical open thrombectomy. | 0, 1, and 3 months | |
Secondary | abandon of AV graft, death | stopped to use the target AVG or mortality | 0, 1, and 3 months |
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