Coronary disease & ACSCohort study
Clinical Experience With a Novel Percutaneous LV Assist Device in High-Risk Percutaneous Intervention (PCI): Primary Results From the SUPPORT I Study
- prospective, single-arm feasibility study
- early feasibility study
- 4 centers in the United States
Authors' conclusion
As an early feasibility study, treatment with the Supira pVAD demonstrated favorable performance and device-related safety. These findings add to existing experience with the Supira pVAD to support a forthcoming pivotal trial in high-risk PCI.
Study context
- Population
- Patients undergoing elective high-risk PCI with hemodynamic support using the Supira percutaneous ventricular assist device (pVAD) systempatients who underwent elective high-risk PCI with the Supira pVAD
- Participants
- Fifteen patients
- Outcome
- Primary feasibility end point: successful initiation and maintenance of hemodynamic support without sustained hypotension or need for alternative mechanical circulatory support
Main finding
As reported in the abstract
Supira pVAD
100%
15 of 15
Observational data: associations, not effects.
Further findings
Procedural characteristics
- Multivessel PCI
- 80%
- Unprotected left main revascularization
- 67%
- Atherectomy and intravascular lithotripsy
- 60%
Technical and procedural success
- Technical success
- 93.3%
- Procedural success
- 86.7%
Safety
| Outcome | Values |
|---|---|
| Primary safety end point: major device-related adverse events attributed to the study device or procedure from device insertion to removal · from the time of device insertion to removal | Supira pVAD 6.7% |
| Deaths · 90 days · unrelated to the study device | Supira pVAD 2 events |
Bleeding events, vascular/limb complications requiring intervention, cardiac structural/valve injury, or stroke attributed to the study device
- None
Original publication
Clinical Experience With a Novel Percutaneous LV Assist Device in High-Risk PCI: Primary Results From the SUPPORT I Study. Circ Cardiovasc Interv. Published 5 May 2026. doi:10.1161/circinterventions.125.016010
Summarised from the published abstract; every number is checked against it