NCT03806621

Rota China Registry

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 980 (actual)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Rotational Atherectomy	Patients with severe calcified lesions will receive rotational atherectomy during index PCI

Timeline

• Start date: 2018-07-18
• Primary completion: 2020-12-27
• Completion: 2022-01-20
• First posted: 2019-01-16
• Last updated: 2023-08-08

Locations

19 sites across 1 country: China