A Post-Approval Study of the RotablatorTM Rotational Atherectomy System in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Beijing Anzhen Hospital
- Enrollment
- 980
- Locations
- 19
- Primary Endpoint
- Major adverse cardiovascular event (MACE) (primary safety endpoint)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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.
Investigators
Shao-Ping Nie
Professor of Medicine, Director, Center for Coronary Artery Disease, Division of Cardiology
Beijing Anzhen Hospital
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Major adverse cardiovascular event (MACE) (primary safety endpoint)
Time Frame: 30 days
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)
Procedural success rate (primary efficacy endpoint)
Time Frame: Peri-procedural
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
Secondary Outcomes
- Target lesion failure (TLF) rate(At 30 days and 12 months post-index procedure)
- TLR rate(At 30 days and 12 months post-index procedure)
- Target vessel failure (TVF) rate(At 30 days and 12 months post-index procedure)
- TVR rate(At 30 days and 12 months post-index procedure)
- Cardiac death rate(At 30 days and 12 months post-index procedure)
- All-cause death rate(At 30 days and 12 months post-index procedure)
- All-cause death or MI rate(At 30 days and 12 months post-index procedure)
- All-cause death, MI, or TVR rate(At 30 days and 12 months post-index procedure)
- Stent thrombosis (ST) rate(At 30 days and 12 months post-index procedure)
- MI rate(At 30 days and 12 months post-index procedure)
- Cardiac death or MI rate(At 30 days and 12 months post-index procedure)
- Subgroup analyses of MACE(At 30 days and 12 months post-index procedure)
- Non-cardiac death rate(At 30 days and 12 months post-index procedure)