MedTrace Logo

Interventional Left Ventricular Assist System for PCI in CHIP Patients

NCT07053618 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2025-08-26

No results posted yet for this study

Summary

Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage heart failure. Percutaneous mechanical circulatory support (pMCS), a key MCS modality, has advanced rapidly in recent years.

In China, pMCS adoption has accelerated significantly, evidenced by year-over-year growth in both specialized centers and clinical cases, alongside continuous technological refinement.

Common pMCS devices include: Intra-Aortic Balloon Pump (IABP), Axial flow pump systems (e.g., Impella®), Extracorporeal Membrane Oxygenation (ECMO). However, no randomized study has compared Impella with VA-ECMO in CHIP patients.

The aim of the study is to evaluate the effectiveness and safety of interventional left ventricular assist system (VADLINK) compared to the VA-ECMO in providing circulatory support for complicated and high-risk patient with indications for PCI.

Conditions

  • High-Risk Percutaneous Coronary Intervention (High-risk PCI)
  • Left Ventricular Assist Devices

Interventions

DEVICE

Implantation of the VADLINK Percutaneous Left Ventricular Assist Device

To implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI).

DEVICE

VA-ECMO

Received venous arterial extracorporeal membrane oxygenation (VA-ECMO) during PCI.

Sponsors & Collaborators

  • Suzhou Hengruihongyuan Medical Technology Co. LTD

    lead INDUSTRY

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
2025-08-06
Primary Completion
2026-12-01
Completion
2027-08-01

Countries

  • China

Study Locations

More Related Trials

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 NCT07053618 on ClinicalTrials.gov