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NOT YET RECRUITING
NCT06639321
NA

Phimume® Percutaneous Left Ventricular Assist System Study

Sponsor: Shanghai NewMed Medical Co., Ltd.

View on ClinicalTrials.gov

Summary

The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus extracorporeal membrane oxygenation (ECMO) for circulatory support during high-risk PCI.

Official title: The Safety and Efficacy of the Percutaneous Left Ventricular Assist System Versus ECMO for Intraoperative Circulatory Support During High-risk Percutaneous Coronary Intervention (PCI): a Prospective, Multi-center, Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

250

Start Date

2024-10-14

Completion Date

2026-10-14

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

DEVICE

Percutaneous Ventricular Assist System

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

DEVICE

extracorporeal membrane oxygenation (ECMO)

ECMO provides intraoperative circulatory support during high-risk PCI.

Locations (6)

The Second Hospital of Jilin University

Jilin, Changchun, China

West China Hospital, Sichuan University

Chengdu, Chengdu, China

Henan Provincial Chest Hospital

Zhengzhou, Henan, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

General Hospital of Northern Theater Command

Shenyang, Liaoning, China