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Phitys I™ Percutaneous Left Ventricular Assist System Study - Trial NCT06357026

Access comprehensive clinical trial information for NCT06357026 through Pure Global AI's free database. This phase not specified trial is sponsored by Shanghai NewMed Medical Co., Ltd. and is currently Not yet recruiting. The study focuses on Coronary Artery Disease. Target enrollment is 344 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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Trial Details
ClinicalTrials.govNCT06357026
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Phitys I™ Percutaneous Left Ventricular Assist System Study
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

Study Focus

Coronary Artery Disease

Percutaneous Ventricular Assist System(Phigine Medical)

Interventional

device

Sponsor & Location

Shanghai NewMed Medical Co., Ltd.

Jilin,Harbin,Zhengzhou,Wuhan,Changsha,Shenyang,Shanghai,Chengdu, China

Timeline & Enrollment

N/A

Apr 01, 2024

Apr 01, 2026

344 participants

Primary Outcome

Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)

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.

ICD-10 Classifications

Cardiovascular disease, unspecified
Atherosclerotic cardiovascular disease, so described
Atherosclerotic heart disease
Abnormal findings on diagnostic imaging of heart and coronary circulation
Coronary vasodilators, not elsewhere classified

Data Source

ClinicalTrials.gov

NCT06357026

Device Trial