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NOT YET RECRUITING
NCT07855614
NA

OPTIMized Diagnosis and Treatment System Based on AI and Multimodal Imaging Fusion for PCI (OPTIMAI-PCI)

Sponsor: Zhejiang Hospital

View on ClinicalTrials.gov

Summary

This study compares an AI-based imaging fusion guidance system with standard intravascular ultrasound-guided PCI in adults with complex coronary artery lesions. The system combines angiography and intravascular ultrasound to help physicians plan and optimize stent placement. The study will assess whether the system improves immediate post-procedure vessel function and stent optimization without increasing safety risks.

Official title: An Optimized Diagnosis and Treatment System Based on Artificial Intelligent and Multimodality Imaging Fusion for Percutaneous Coronary Intervention: a Prospective and Multicenter Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

554

Start Date

2026-09

Completion Date

2028-12

Last Updated

2026-10-02

Healthy Volunteers

No

Interventions

DEVICE

AI-Based Imaging Fusion Guidance System

AI-based software device for real-time fusion of coronary angiography and intravascular ultrasound during PCI. It supports virtual stent planning, stent recognition and reconstruction, quantitative evaluation of stent expansion and apposition, detection of edge complications, and functional assessment support including micro quantitative flow ratio.

PROCEDURE

Standard IVUS-Guided PCI

Percutaneous coronary intervention guided by intravascular ultrasound according to current clinical guidelines, including pre-procedural imaging assessment, stent selection, and post-procedural optimization.

Locations (8)

Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Hangzhou First People's Hospital affiliated with Westlake University School of Medicine

Hangzhou, Zhejiang, China

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Hospital

Hangzhou, Zhejiang, China

Yuhuan Second People's Hospital

Yuhuan, Zhejiang, China

Zhoushan Hospital

Zhoushan, Zhejiang, China