Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis—a multi-center study
Abstract Introduction Renal artery stenosis (RAS) is a significant reason for secondary hypertension. Impaired renal function and subsequent cardiopulmonary dysfunction could also occur. Patients of non-atherosclerotic RAS has a relatively young age and long life expectancy. Revascularization with p...
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2023-10-01
|
| Series: | BMC Cardiovascular Disorders |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12872-023-03484-5 |
| _version_ | 1797578292551745536 |
|---|---|
| author | Xitao Song Yining Fu Zhichao Lai Xiao Di Rong Zeng Jiang Shao Leng Ni Zhili Liu Xiaojun Song Wei Ye Changwei Liu Bao Liu Yuehong Zheng Yuexin Chen |
| author_facet | Xitao Song Yining Fu Zhichao Lai Xiao Di Rong Zeng Jiang Shao Leng Ni Zhili Liu Xiaojun Song Wei Ye Changwei Liu Bao Liu Yuehong Zheng Yuexin Chen |
| author_sort | Xitao Song |
| collection | DOAJ |
| description | Abstract Introduction Renal artery stenosis (RAS) is a significant reason for secondary hypertension. Impaired renal function and subsequent cardiopulmonary dysfunction could also occur. Patients of non-atherosclerotic RAS has a relatively young age and long life expectancy. Revascularization with percutaneous transluminal angioplasty (PTA) is a viable treatment option. However, restenosis is unavoidable which limits its use. Drug-coated balloon (DCB) has been proven to be effective in restenosis prevention in femoropopliteal arterial diseases and in patients with renal artery stenosis. And PTA for Renal artery fibromuscular dysplasia is safe and clinically successful. Therefore, we could speculate that DCB might have potential efficacy in non-atherosclerotic RAS treatment. Methods and analysis This will be a randomized multi-center-controlled trial. Eighty-four eligible participants will be assigned randomly in a 1:1 ratio to the control group (plain old balloon, POB) and the experimental group (DCB). Subjects in the former group will receive balloon dilatation alone, and in the latter group will undergo the DCB angioplasty. The DCB used in this study will be a paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China). Follow-up visits will be scheduled 1, 3, 6, 9, and 12 months after the intervention. Primary outcomes will include controlled blood pressure and primary patency in the 9-month follow-up. Secondary outcomes will include technical success rate, complication rate, and bail-out stenting rate. Trial registration ClinicalTrials.gov (number NCT 05858190). Protocol version V.4 (3 May 2023). |
| first_indexed | 2024-03-10T22:20:51Z |
| format | Article |
| id | doaj.art-f74ebd8529974b23835312f3e0368be9 |
| institution | Directory Open Access Journal |
| issn | 1471-2261 |
| language | English |
| last_indexed | 2024-03-10T22:20:51Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cardiovascular Disorders |
| spelling | doaj.art-f74ebd8529974b23835312f3e0368be92023-11-19T12:18:44ZengBMCBMC Cardiovascular Disorders1471-22612023-10-012311810.1186/s12872-023-03484-5Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis—a multi-center studyXitao Song0Yining Fu1Zhichao Lai2Xiao Di3Rong Zeng4Jiang Shao5Leng Ni6Zhili Liu7Xiaojun Song8Wei Ye9Changwei Liu10Bao Liu11Yuehong Zheng12Yuexin Chen13Department of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesDepartment of Vascular Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical SciencesAbstract Introduction Renal artery stenosis (RAS) is a significant reason for secondary hypertension. Impaired renal function and subsequent cardiopulmonary dysfunction could also occur. Patients of non-atherosclerotic RAS has a relatively young age and long life expectancy. Revascularization with percutaneous transluminal angioplasty (PTA) is a viable treatment option. However, restenosis is unavoidable which limits its use. Drug-coated balloon (DCB) has been proven to be effective in restenosis prevention in femoropopliteal arterial diseases and in patients with renal artery stenosis. And PTA for Renal artery fibromuscular dysplasia is safe and clinically successful. Therefore, we could speculate that DCB might have potential efficacy in non-atherosclerotic RAS treatment. Methods and analysis This will be a randomized multi-center-controlled trial. Eighty-four eligible participants will be assigned randomly in a 1:1 ratio to the control group (plain old balloon, POB) and the experimental group (DCB). Subjects in the former group will receive balloon dilatation alone, and in the latter group will undergo the DCB angioplasty. The DCB used in this study will be a paclitaxel-coated balloon (Orchid, Acotec Scientific Holdings Limited, Beijing, China). Follow-up visits will be scheduled 1, 3, 6, 9, and 12 months after the intervention. Primary outcomes will include controlled blood pressure and primary patency in the 9-month follow-up. Secondary outcomes will include technical success rate, complication rate, and bail-out stenting rate. Trial registration ClinicalTrials.gov (number NCT 05858190). Protocol version V.4 (3 May 2023).https://doi.org/10.1186/s12872-023-03484-5HypertensionRenal artery obstructionAngioplastyBalloonTreatment outcomeResearch design |
| spellingShingle | Xitao Song Yining Fu Zhichao Lai Xiao Di Rong Zeng Jiang Shao Leng Ni Zhili Liu Xiaojun Song Wei Ye Changwei Liu Bao Liu Yuehong Zheng Yuexin Chen Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis—a multi-center study BMC Cardiovascular Disorders Hypertension Renal artery obstruction Angioplasty Balloon Treatment outcome Research design |
| title | Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis—a multi-center study |
| title_full | Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis—a multi-center study |
| title_fullStr | Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis—a multi-center study |
| title_full_unstemmed | Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis—a multi-center study |
| title_short | Drug-coated balloon for treatment of non-atherosclerotic renal artery stenosis—a multi-center study |
| title_sort | drug coated balloon for treatment of non atherosclerotic renal artery stenosis a multi center study |
| topic | Hypertension Renal artery obstruction Angioplasty Balloon Treatment outcome Research design |
| url | https://doi.org/10.1186/s12872-023-03484-5 |
| work_keys_str_mv | AT xitaosong drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT yiningfu drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT zhichaolai drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT xiaodi drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT rongzeng drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT jiangshao drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT lengni drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT zhililiu drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT xiaojunsong drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT weiye drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT changweiliu drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT baoliu drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT yuehongzheng drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy AT yuexinchen drugcoatedballoonfortreatmentofnonatheroscleroticrenalarterystenosisamulticenterstudy |