Status:
COMPLETED
Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary Angiography
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, multicenter, self-control clinical trial designed to assess the efficacy of AccuFFRangio, a novel method for evaluating the functional significance of coronary stenosis from cor...
Eligibility Criteria
Inclusion
- Age ≥18 years;
- Stable or unstable angina, or myocardial infarction after the acute phase, indication for FFR in at least one vessel;
- Able to provide informed consent.
Exclusion
- Subjects judged unsuitable for diagnostic intervention or FFR;
- Myocardial infarction within 6 days;
- LVEF ≤50%;
- eGFR \<60ml/min（1.73m²）
- Severe coagulation dysfunction or bleeding disorders;
- Allergic to iodine contrast agent or adenosine, or ineligible for adenosine;
- Participated in other clinical trials within 1 months;
- Other situations that were not suitable for inclusion, as judged by investigators.
Key Trial Info
Start Date :
November 4 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 24 2022
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT04814550
Start Date
November 4 2020
End Date
February 24 2022
Last Update
March 8 2023
Active Locations (1)
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1
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, China, 310009