Status:
COMPLETED
Rota China Registry
Lead Sponsor:
Beijing Anzhen Hospital
Collaborating Sponsors:
BSC International Medical Trading (Shanghai) Co., Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- Subject must meet one of following angiographic/procedural inclusion criteria:
- 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
- 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)
Key Trial Info
Start Date :
July 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 20 2022
Estimated Enrollment :
980 Patients enrolled
Trial Details
Trial ID
NCT03806621
Start Date
July 18 2018
End Date
January 20 2022
Last Update
August 8 2023
Active Locations (19)
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1
The First Affiliated Hospital of USTC
Hefei, Anhui, China
2
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
3
Beijing Hospital
Beijing, Beijing Municipality, China
4
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China