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NCT07855614
OPTIMized Diagnosis and Treatment System Based on AI and Multimodal Imaging Fusion for PCI (OPTIMAI-PCI)
Conditions: Coronary Artery Disease
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 554
Sponsor: Zhejiang Hospital
Location: Affiliated Hospital of Hangzhou Normal University Hangzhou Zhejiang
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.
Eligibility Criteria
Inclusion Criteria:
1. Age 18 to 80 years, inclusive, at the time of informed consent.
2. Planned PCI for a target non-left-main coronary lesion meeting at least one of the following: typical myocardial ischemic symptoms with angiographic stenosis \>70%; atypical symptoms with angiographic stenosis \>=90%; functional measurement by FFR or QFR \
Source: ClinicalTrials.gov (NCT07855614). StuddyBuddy aggregates publicly available trial information.