Rota China Registry

Coronary Artery Disease Clinical Trial

Official title:

A Post-Approval Study of the RotablatorTM Rotational Atherectomy System in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03806621
• Other study ID #: 2017033
• Status: Completed
• Start date: July 18, 2018
• Est. completion date: January 20, 2022

Study information

• Verified date: August 2023
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 980
• Est. completion date: January 20, 2022
• Est. primary completion date: December 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Rotational Atherectomy
Patients with severe calcified lesions will receive rotational atherectomy during index PCI

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
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	Sir Run Run Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of USTC	Hefei	Anhui
China	Qilu Hospital (Qingdao), Shandong University	Jinan	Shandong
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Nanjing First hospital, Nanjing Medical University	Nanjing	Jiangsu
China	First Hospital of China Medical University	Shenyang	Liaoning
China	Tianjin Fourth Central Hospital	Tianjin	Tianjin
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
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	Fuwai Central China Cardiovascular Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	BSC International Medical Trading (Shanghai) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of arterial perforation (rotational atherectomy related or non-related)		Peri-procedural
Other	Rate of abrupt coronary occlusion (including dissection and thrombosis)		Peri-procedural
Other	Rate of significant coronary dissection (NHLBI types C-F)		Peri-procedural
Other	Rate of consistent no reflow		Peri-procedural
Primary	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
Primary	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	TLR rate		At 30 days and 12 months post-index procedure
Secondary	Target lesion failure (TLF) rate		At 30 days and 12 months post-index procedure
Secondary	TVR rate		At 30 days and 12 months post-index procedure
Secondary	Target vessel failure (TVF) rate		At 30 days and 12 months post-index procedure
Secondary	MI rate		At 30 days and 12 months post-index procedure
Secondary	Cardiac death rate		At 30 days and 12 months post-index procedure
Secondary	Non-cardiac death rate		At 30 days and 12 months post-index procedure
Secondary	All-cause death rate		At 30 days and 12 months post-index procedure
Secondary	Cardiac death or MI rate		At 30 days and 12 months post-index procedure
Secondary	All-cause death or MI rate		At 30 days and 12 months post-index procedure
Secondary	All-cause death, MI, or TVR rate		At 30 days and 12 months post-index procedure
Secondary	Stent thrombosis (ST) rate		At 30 days and 12 months post-index procedure
Secondary	Subgroup analyses of MACE	1. Age (< 65 years vs. = 65 years), 2. Female, 3. Hypertension, 4. Diabetes, 5. CKD, 6. Left ventricular ejection fraction (= 50% vs. > 50%), 7. LM lesion, 8. Long lesion, 9. CTO, 10. Bifurcation lesion, 11. Speed of rotation, 12. Maximal burr size, 13. IVUS or OCT use	At 30 days and 12 months post-index procedure