Rota China Registry
A Post-Approval Study of the RotablatorTM Rotational Atherectomy System in China
1 other identifier
observational
980
1 country
19
Brief Summary
Rotational atherectomy (RA) facilitates percutaneous coronary intervention for complex de novo lesions with severe calcification. Some observational studies and a small randomized trial indicated that a strategy of routine RA did not conferred reduction in restenosis or MACE, but these studies are limited by missing follow-up, insufficient power to compare outcomes, and confounding factors in the RA group (long lesion length, etc.). With recent developments in medical therapy, advances in design and delivery of drug-eluting stents (DES), and advances in noninvasive and intravascular coronary imaging, the use of RA in current real-world practice remains to be well determined. We aimed to compile real-world clinical outcomes data for the RotablatorTM Rotational Atherectomy System in routine clinical practice in China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2018
CompletedFirst Submitted
Initial submission to the registry
December 12, 2018
CompletedFirst Posted
Study publicly available on registry
January 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2022
CompletedAugust 8, 2023
August 1, 2023
2.4 years
December 12, 2018
August 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Major adverse cardiovascular event (MACE) (primary safety endpoint)
The composite of any ischemia-driven target lesion revascularization (TLR), myocardial infarction (MI), or cardiac death. Periprocedural myocardial infarction, defined as in patients with normal baseline CK-MB, the peak CK-MB measured within 48 hours of the procedure rises to ≥ 10 x the local laboratory ULN, or to ≥ 5 x ULN with new pathologic Q-waves in ≥ 2 contiguous leads or new persistent LBBB (according to SCAI definition. J Am Coll Cardiol 2013;62:1563-70)
30 days
Procedural success rate (primary efficacy endpoint)
A mean lesion diameter stenosis \<30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of in-hospital MI, target vessel revascularization (TVR), or cardiac death
Peri-procedural
Secondary Outcomes (13)
TLR rate
At 30 days and 12 months post-index procedure
Target lesion failure (TLF) rate
At 30 days and 12 months post-index procedure
TVR rate
At 30 days and 12 months post-index procedure
Target vessel failure (TVF) rate
At 30 days and 12 months post-index procedure
MI rate
At 30 days and 12 months post-index procedure
- +8 more secondary outcomes
Other Outcomes (4)
Rate of arterial perforation (rotational atherectomy related or non-related)
Peri-procedural
Rate of abrupt coronary occlusion (including dissection and thrombosis)
Peri-procedural
Rate of significant coronary dissection (NHLBI types C-F)
Peri-procedural
- +1 more other outcomes
Study Arms (1)
Rotational Atherectomy
Interventions
Patients with severe calcified lesions will receive rotational atherectomy during index PCI
Eligibility Criteria
This national, multi-center, prospective, observational study will enroll at least 1000 subjects in about 18 to 20 sites in China. All subjects who are candidates for PCI, signed the informed consent form and eligible to receive the treatment using RotablatorTM Rotational Atherectomy System will be evaluated for enrollment in this study.
You may qualify if:
- Age ≥18 years old
- 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
You may not qualify if:
- Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute MI within 2 weeks
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
The First Affiliated Hospital of USTC
Hefei, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, 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
Related Publications (1)
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.
PMID: 39223992DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine, Director, Center for Coronary Artery Disease, Division of Cardiology
Study Record Dates
First Submitted
December 12, 2018
First Posted
January 16, 2019
Study Start
July 18, 2018
Primary Completion
December 27, 2020
Study Completion
January 20, 2022
Last Updated
August 8, 2023
Record last verified: 2023-08