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Rota China Registry

NCT03806621 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 980

Last updated 2023-08-08

No results posted yet for this study

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

Interventions

PROCEDURE

Rotational Atherectomy

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

Sponsors & Collaborators

  • BSC International Medical Trading (Shanghai) Co., Ltd.

    collaborator OTHER

  • Beijing Anzhen Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2020-12-27
Completion
2022-01-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03806621 on ClinicalTrials.gov