A Prospective, Multicenter, Self-control Clinical Trial on the Effectiveness and Safety of AccuFFRangio Plus

March 22, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Prospective, Multicenter, Self-control Clinical Trial on the Effectiveness and Safety to Access Coronary Artery Stenosis Blood Flow Reserve Fraction of AccuFFRangio Plus

This is a prospective, multicenter, self-control clinical trial. 318 patients who need selective operation to evaluate the function of coronary artery were selected and measured with AccuFFRangio Plus and FFR. The data of the experimental group was defined as: FFR value at the distal end of stenosis was obtained by calculating the original X-ray angiographic images of the coronary arteries before operation with the non-invasive blood flow reserve analysis software of Hangzhou ArteryFlow Technology Co., Ltd. The gold standard group data is the clinical measured FFR (clinical gold standard) at the stenosis lesions. It is defined that when the coronary artery reaches the maximum congestion state, the pressure value at the distal end of the stenosis lesions is accurately measured by the guide wire with a pressure sensor, and the ratio value with the coronary mouth pressure is the FFR. By comparing the data of the experimental group and the data of the gold standard group, the effectiveness and safety of the devices in the experimental group were evaluated.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310009
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine at Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  1. Patients with stable angina, unstable angina, myocardial infarction after acute phase;
  2. Visually, the degree of diameter stenosis of coronary artery stenosis segment was greater than and equal to 30% and less than and equal to 90%.

Description

Inclusion Criteria:

  1. Male or female above 18 years old;
  2. Have stable or unstable angina symptoms, or need to measure FFR after acute myocardial infarction;
  3. The subjects knew about the experiment and signed the informed consent voluntarily.

Exclusion Criteria:

  1. People is considered not suitable for a diagnostic intervention by the researcher determines;
  2. Myocardial infarction within 6 days;
  3. Left ventricular ejection fraction(LVEF)≤50%;
  4. eGFR<60ml/min（1.73m²）
  5. Severe coagulation dysfunction or hemorrhagic disease;
  6. Allergic to iodine contrast agent or adenosine, or not suitable for adenosine;
  7. Having participated in other clinical trials within 1 months;
  8. Other situations that the researchers judged were not suitable for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The accuracy of the comparison for test result between the test software and the gold standard FFR
Time Frame: The specific duration of time over which each participant is assessed is within a week
The specific duration of time over which each participant is assessed is within a week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Changling Li, MD, 2nd Affiliated Hospital, School of Medicine at Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 4, 2020

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

June 1, 2021

Study Registration Dates

First Submitted

December 6, 2020

First Submitted That Met QC Criteria

March 22, 2021

First Posted (ACTUAL)

March 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • clinical 2020-100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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