Rota China Registry

Beijing Anzhen Hospital980 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

980

Conditions

Coronary Artery Disease

Interventions

Rotational AtherectomyPROCEDURE

Patients with severe calcified lesions will receive rotational atherectomy during index PCI

Medical Language ↔ Plain English

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)

Locations (19)

The First Affiliated Hospital of USTC

Hefei, Anhui, China

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 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

...and 9 more locations

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: Peri-procedural