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NCT06357026

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
Shanghai NewMed Medical Co., Ltd.·ClinicalTrials.gov·device·Device trialNot yet recruiting
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Study focus
Disease/Condition
Coronary Artery Disease
Drug/Device/Intervention
Percutaneous Ventricular Assist System（Phigine Medical）
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Shanghai NewMed Medical Co., Ltd.
Location
Jilin,Harbin,Zhengzhou,Wuhan,Changsha,Shenyang,Shanghai,Chengdu, China
Timeline & enrollment
Phase
N/A
Start date
Apr 01, 2024
End date
Apr 01, 2026
Enrollment
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, unspecifiedAtherosclerotic cardiovascular disease, so describedAtherosclerotic heart diseaseAbnormal findings on diagnostic imaging of heart and coronary circulationCoronary vasodilators, not elsewhere classified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06357026
Type
Device Trial
About this record

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.