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Completed

NCT Number: NCT04814550

Diagnostic Accuracy of CFD-Based Fractional Flow Reserve Derived From Coronary Angiography

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 coronary angiography, with FFR as the reference standard.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hanzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

FFR

Diagnostic Test

FFR measured by pressure wire, AccuFFRangio computed by coronary angiographic images

Other names: AccuFFRangio

Primary outcomes

  1. Diagnostic accuracy of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard

    Time frame: 7 days

    Hemodynamically significant coronary artery stenosis: FFR≤0.8

Secondary outcomes

  1. Sensitivity and specificity of AccuFFRangio to determine hemodynamically significant coronary artery stenosis compared to FFR as the reference standard

    Time frame: 7 days

    Hemodynamically significant coronary artery stenosis: FFR≤0.8

  2. AUC of AccuFFRangio for discrimination of hemodynamically significant coronary artery stenosis

    Time frame: 7 days

    Hemodynamically significant coronary artery stenosis: FFR≤0.8

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Angiography-Derived Fractional Flow Reserve for Functional Evaluation of Coronary Artery Disease

Acronym: ACCURATE

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 24, 2021
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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