Rota China Registry

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Rotational Atherectomy

• Study Type: Observational
• Enrollment (Actual): 980

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated hospital of USTC
  • Beijing
    • Beijing, Beijing, China
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China, 100029
      • 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
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital, Guangdong Academy of Medical Science
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
    • Zhengzhou, Henan, China
      • Fuwai Central China Cardiovascular Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital, Nanjing Medical University
  • Liaoning
    • Shenyang, Liaoning, China
      • First Hospital of China Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University
    • Xi'an, Shaanxi, China
      • Xijing Hospital, the Fourth Military Medical University
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital (Qingdao), Shandong University
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital, Sichuan University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Fourth Central Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • The First People's Hospital of Yunnan Province
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rotational Atherectomy	Procedure: Rotational Atherectomy; Patients with severe calcified lesions will receive rotational atherectomy during index PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cardiac death rate		At 30 days and 12 months post-index procedure
Non-cardiac death rate		At 30 days and 12 months post-index procedure
All-cause death rate		At 30 days and 12 months post-index procedure
Cardiac death or MI rate		At 30 days and 12 months post-index procedure
All-cause death or MI rate		At 30 days and 12 months post-index procedure
All-cause death, MI, or TVR rate		At 30 days and 12 months post-index procedure
Stent thrombosis (ST) rate		At 30 days and 12 months post-index procedure
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

Other Outcome Measures

Outcome Measure	Time Frame
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
Rate of consistent no reflow	Peri-procedural

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital
• Collaborators: BSC International Medical Trading (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): December 27, 2020
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; coronary artery disease; rotational atherectomy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2017033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No