SAVE-PCI: NyokAssistâ„¢ Small-Bore VAD vs. IABP in Elective High-Risk PCI (NCT07010965) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SAVE-PCI: NyokAssistâ„¢ Small-Bore VAD vs. IABP in Elective High-Risk PCI
China236 participantsStarted 2024-07-31
Plain-language summary
SAVE-PCI is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssistâ„¢, a small-bore percutaneous ventricular assist device (pVAD), in comparison with intra-aortic balloon pump (IABP) in patients undergoing elective high-risk percutaneous coronary intervention (PCI).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age eligible (18 ≤ Age ≤ 80)
✓. Subject is indicated for a non-emergent percutaneous treatment of at least one de novo or restenotic lesion in a native coronary vessel or bypass graft .
✓. Patient presence at least one of the following a or b:
✓. Intervention on an unprotected left main coronary artery or intervention on the last patent coronary artery .
✓. Intervention on patient presenting with three-vessel\* disease.
✓. Ejection Fraction ≤40% or Coronary rotational atherectomy or According to the assessment of the cardiac team, PCI requires hemodynamic support .
✓. Volunteered to participate and Signed Informed Consent and able to cooperate with the whole trial process.
Exclusion criteria
✕. Acute ST elevation Myocardial Infarction within 24 hours or CK-MB that have not normalized after acute ST elevation Myocardial Infarction.
✕. Pre-procedure cardiac arrest within 24 hours of enrollment requiring CPR.
✕. Subject is in cardiogenic shock defined as:
✕. Mural thrombus in the left ventricle.
✕. The presence of aortic valve replacement or mechanical circulatory support device.