Rota China Registry

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

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.

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)