Aortic & peripheral vascular diseaseCohort study
The PERFORMANCE II Trial
- Prospective single-arm study
- multicentre
Authors' conclusion
The rate of major adverse events was extremely low, demonstrating the study system is a safe, effective, and durable treatment option for high-risk patients.
Study context
- Population
- Patients at elevated risk for adverse events from carotid endarterectomy, treated with a novel carotid stent system (stent, adjustable integrated embolic filter, postdilation balloon); US and Europe
- Participants
- 305 patients · 32 centres
- Outcome
- Composite of:
- Death
- All stroke and MI within 30 days of the procedure
- Plus ipsilateral stroke through 12 months
- Follow-up
- 12 months
Main finding
As reported in the abstract
Primary endpoint:
- Death
- All stroke
- MI within 30 days plus ipsilateral stroke through 12 months
12-month primary endpoint rate
2.8%
Observational data: associations, not effects.
Further findings
30-day all stroke plus ipsilateral stroke through 12 months
- Rate
- 1.8%
Stroke and death at 30 days
- Minor strokes: 4
- 1.3%
- Stroke/death rate
- 1.6%
- Stroke/death/myocardial infarction (MI) rate
- 2.3%
- No major strokes
- 1 cardiac death on day 30
Safety
Major stroke, clinically driven TLR, stent thrombosis, neurological death · 12 months
- No major strokes, clinically driven target lesion revascularizations, stent thromboses or neurological deaths
Original publication
The PERFORMANCE II Trial. JACC Cardiovasc Interv. Published 8 January 2025. doi:10.1016/j.jcin.2024.10.031
Summarised from the published abstract; every number is checked against it