Rota China Registry

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Rotational Atherectomy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rotational Atherectomy<br> | Procedure: Rotational Atherectomy<br>* Patients with severe calcified lesions will receive rotational atherectomy during index PCI<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, percutaneous coronary intervention, rotational atherectomy