Rota China Registry

Capital Medical University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Rotational Atherectomy

Study type: Observational

Funder types: Other

Identifiers

NCT03806621

2017033

Details and patient eligibility

About

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.

Enrollment: 980 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

980 participants in 1 patient group

Rotational Atherectomy

Treatment:

Procedure: Rotational Atherectomy