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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular balloon | Active Comparator | Use the regular balloon to perform standard balloon angioplasty. |
|
| DCB (paclitaxel-coated balloon) | Active Comparator | Use DCB (paclitaxel-coated balloon) to perform additional balloon angioplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regular balloon | Device | Randomization: to use regular balloon to treat stent graft restenosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Late luminal loss | The late luminal loss found by IVUS on follow-up in comparison to index procedure. | 0, 1, and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| minimal luminal area and diameter | Done by IVUS on follow-up in comparison to index procedure. | 0, 1, and 3 months |
| restenosis rate | Compare with follow-up angiography. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mu-Yang Hsieh, MD | Contact | 886-35326151 | 2009 | h11135@hch.gov.tw |
| Chih-Cheng Wu, MD | Contact | 886-35326151 | 2010 | chihchengwumd@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mu-Yang Hsieh, MD | National Taiwan University Hospital Hsin-Chu Branch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsinchu Branch | Recruiting | Hsinchu | Hsinchu City | 300 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42055649 | Derived | Wang H, Qin J, Liu C, Gao X, Ma L, Cui S, Lu X, Lu S, Huang Z, Tong Z, Guo L, Guo J. Cold Laser vs Excimer Laser in Lower Limb Atherosclerosis: A Prospective Multicenter Randomized Trial. JACC Cardiovasc Interv. 2026 Apr 27;19(8):1021-1035. doi: 10.1016/j.jcin.2026.02.036. | |
| 37209996 | Derived | Hsieh MY, Lin PS, Liao MT, Lin L, Chen TY, Boon JC, Yang TF, Wu CC. A Randomised Trial Comparing Drug Coated Balloons and Conventional Balloons for the Treatment of Stent Graft Stenosis in Dialysis Vascular Access. Eur J Vasc Endovasc Surg. 2023 Aug;66(2):253-260. doi: 10.1016/j.ejvs.2023.05.028. Epub 2023 May 18. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 25, 2017 | Nov 24, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 25, 2017 | Nov 24, 2017 | ICF_001.pdf |
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The IVUS interpreter and follow-up evaluators are masked.
| DCB (paclitaxel-coated balloon) | Device | Randomization: to use DCB (paclitaxel-coated balloon, Ranger, Boston-Scientific) to treat stent graft restenosis. The paclitaxel dose is 2 ug/mm2 delivered with the Ranger drug-coated balloon. |
|
| 0, 1, and 3 months |
| repeated intervention | defined by repeated endovascular balloon angioplasty or endovascular thrombectomy or surgical open thrombectomy. | 0, 1, and 3 months |
| abandon of AV graft, death | stopped to use the target AVG or mortality | 0, 1, and 3 months |