Clinical Trial

Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)

Not Yet Recruiting
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Record status
This record was last updated January 1, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients during high-risk PCI procedures compared to veno-arterial extracorporeal membrane oxygenation (VA-ECMO).The participants will be randomly assigned to the experimental group or the control group after enrollment, and will undergo percutaneous coronary intervention(PCI) with support from Ventiflow LP or VA-ECMO respectively. All participants need to undergo a 3-month follow-up after operative.
Trial Details
NCT Number NCT06754839
Lead Sponsor Suzhou Hearthill Medical Technology Co.,LTD
Conditions Coronary Artery Disease, Heart Failure, High-risk PCI
Enrollment 250 participants
Start Date 2024-12
Primary Completion 2025-10 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-01-01