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

NCT06754839 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-01-01

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Suzhou Hearthill Medical Technology Co.,LTD

    lead INDUSTRY

Principal Investigators

  • Yujie Zhou, MD · Beijing Anzhen Hospital

  • Yong He, MD · West China Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2025-10-31
Completion
2025-12-31

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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 NCT06754839 on ClinicalTrials.gov