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SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI

NCT07010965 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-01-12

No results posted yet for this study

Summary

SAVE-PCI 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 intra-aortic balloon pump (IABP) in patients undergoing elective high-risk percutaneous coronary intervention (PCI).

Conditions

  • High-Risk PCI

Interventions

DEVICE

NyokAssist™

The 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 .

DEVICE

IABP Intra-aortic balloon pump

IABP uses counterpulsation to provide coronary flow

Sponsors & Collaborators

  • magAssist, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-11-21
Completion
2026-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07010965 on ClinicalTrials.gov