SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
ConditionHigh-risk PCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsormagAssist, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
LVEF ≤ 35%; or LVEF ≤ 40% with NYHA functional class ≥ III.
Disqualifiers
CI < 2.2 L/min/m2 and PCWP > 15 mmH
Hypotension (systolic BP < 90 mmHg for >30 minutes or the need for supportive measures to maintain a systolic BP of greater than or equal to 90 mmHg) AND end organ hypoperfusion (cool extremities OR [a urine output of < 30 mL/hour AND a HR > 60 BPM]) 4.Mural thrombus in the left ventricle. 5.The presence of aortic valve replacement or mechanical circulatory support device. 6.Subject has mechanical complications of myocardial infarction.
Trial design
Design model
Parallel
Treatments tested in this trial
NyokAssist
DeviceThe NyokAssist™ Ventricular Assist Device can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta .
ECMO
DeviceExtracorporeal Membrane Oxygenation provides extracorporeal gas exchange through use of a membrane oxygenator. Blood is drained from a central vein and returned after oxygenation into the arterial circulation .
Treatment groups
204 Participants
are divided into 2 treatment groupsGroup A: NyokAssist™Experimental treatment 1 intervention
Group B: ECMOActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
30-day MAE rate after randomization
The major adverse events are defined as: Death. Stroke. Myocardial infarction. Revascularization. Rehospitalization due to cardiovascular reasons. Type 3, 4, and 5 bleeding (as defined by MCS-ARC). Acute kidney injury. Severe device-related adverse events. Cardiopulmonary resuscitation.
Time frame
30-day after randomizationSponsors and contacts
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Source ClinicalTrials.gov