Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
980 participants
OBSERVATIONAL
2018-07-18
2022-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rotational Atherectomy
Rotational Atherectomy
Patients with severe calcified lesions will receive rotational atherectomy during index PCI
Interventions
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Rotational Atherectomy
Patients with severe calcified lesions will receive rotational atherectomy during index PCI
Eligibility Criteria
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Inclusion Criteria
* Subject who is clinically indicated for PCI/stenting
* Written informed consent
* Subject is willing to comply with all protocol-required follow-up evaluation
* Target lesion is moderately to severely calcified by visual estimate
* Unsuccessful balloon dilatation of the target lesion
* Unsuccessful passage of device(s) (microcatheter, balloon, or stent) across the target lesion
Exclusion Criteria
* Subject has any of the following angiographic findings:
* Thrombus present in the target vessel (by visual estimate)
* Significant dissection present in the target vessel (NHLBI types C-F)
* Lesion angulation \> 60°(by visual estimate)
18 Years
ALL
No
Sponsors
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BSC International Medical Trading (Shanghai) Co., Ltd.
OTHER
Beijing Anzhen Hospital
OTHER
Responsible Party
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Shao-Ping Nie
Professor of Medicine, Director, Center for Coronary Artery Disease, Division of Cardiology
Locations
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The First Affiliated Hospital of USTC
Hefei, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital, Guangdong Academy of Medical Science
Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Nanjing First hospital, Nanjing Medical University
Nanjing, Jiangsu, China
First Hospital of China Medical University
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Xijing Hospital, the Fourth Military Medical University
Xi'an, Shaanxi, China
Qilu Hospital (Qingdao), Shandong University
Jinan, Shandong, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Fourth Central Hospital
Tianjin, Tianjin Municipality, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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References
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Wang X, Zhang H, Bai X, Zhang L, Li C, Mao X, Chen J, Luo J, Zhao Y, Zhou B, You B, Zhang Y, Ma L, Du Z, Chen Y, Sun F, Qiu C, Shen Z, Wen S, Mintz GS, Ye F, Nie S; China Rota Elite Group. Practices and outcomes of rotational atherectomy in China: The Rota China registry. Catheter Cardiovasc Interv. 2024 Oct;104(4):664-675. doi: 10.1002/ccd.31211. Epub 2024 Sep 3.
Other Identifiers
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2017033
Identifier Type: -
Identifier Source: org_study_id
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