Status: Recruiting
SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
SAVE-PCI Ⅱ is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with ECMO in patients undergoing elective high-risk percutaneous coronary intervention (PCI).
Participants needed: 204
Trial details
Age: 18-90Biological sex: AllType: InterventionalSponsor: magAssist, Inc.Updated: Oct 6, 2026Locations: 14
Eligibility criteria
LVEF ≤ 35%; or LVEF ≤ 40% with NYHA functional class ≥ III.
CI < 2.2 L/min/m2 and PCWP > 15 mmH [+1]