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Phitys I™ Percutaneous Left Ventricular Assist System Study

NCT06357026 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 344

Last updated 2024-04-10

No results posted yet for this study

Summary

The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI.

Conditions

Interventions

DEVICE

Percutaneous Ventricular Assist System（Phigine Medical）

Percutaneous Ventricular Assist System or IABP provides intraoperative circulatory support during high-risk PCI.

DEVICE

intra-aortic balloon pump (IABP)

IABP provides intraoperative circulatory support during high-risk PCI.

Sponsors & Collaborators

  • Shanghai Phigine Medical Technology Co., Ltd.

    collaborator UNKNOWN

  • Shanghai NewMed Medical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yaling Han · The General Hospital of Northern Theater Command

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
2024-04-01
Primary Completion
2025-05-01
Completion
2026-04-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06357026 on ClinicalTrials.gov