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NOT YET RECRUITING
NCT06357026
NA

Phitys I™ 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 intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI.

Official title: The Safety and Efficacy of the Percutaneous Left Ventricular Assist System 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

344

Start Date

2024-04-01

Completion Date

2026-04-01

Last Updated

2024-04-10

Healthy Volunteers

No

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.

Locations (8)

The Second Hospital of Jilin University

Jilin, Changchun, China

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 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

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China