NCT06754839

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

Clinical Trial Evaluating the Effectiveness and Safety of Percutaneous Left Ventricular Assist Device in Supporting High-risk Percutaneous Coronary Intervention

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Suzhou Hearthill Medical Technology Co.,LTD · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Heart Failure
• High-risk PCI

Interventions

Type	Name	Description
DEVICE	Percutaneous left ventricular assist device(Ventiflow LP)	The PCI will be completed with the support of percutaneous left ventricular assist device(Ventiflow LP).
DEVICE	VA-ECMO	The PCI will be completed with the support of Veno-arterial extracorporeal membrane oxygenation (VA-ECMO).

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2025-01-01
• Last updated: 2025-01-01