A Blind, Self Controlled, Multicenter Clinical Trial on the Effectiveness and Safety of Noninvasive Flow Reserve Score Analysis Software for Coronary Angiography (CTFFR)

This is a blind evaluation, self-control, multicenter clinical trial. 340 patients who need selective operation to evaluate the function of coronary artery were selected and measured with ctffr 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 DICOM data of coronary CT angiography (CCTA) 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: CHD - Coronary Heart Disease

• Study Type: Observational
• Enrollment (Anticipated): 340

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine at Zhejiang University
      • Contact: Changling Li, MD; Phone Number: +86-13718364297; Email: 153814599@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Select subjects who need selective surgery for coronary angiography and vascular function evaluation

Description

Inclusion Criteria:

1. The age is 18-75 years old (including 18 and 75 years old);
2. Subjects with clinical need and consent for coronary angiography;
3. Can provide the results of coronary CT angiography within 60 days or agree to carry out coronary CT angiography;
4. The subjects knew about the experiment and signed the informed consent voluntarily.

Exclusion Criteria:

1. Patients who have had percutaneous coronary intervention (PCI);
2. Patients who had CABG;
3. Acute coronary syndrome, such as acute ST segment elevation;
4. Severe tachycardia or arrhythmia;
5. Patients with severe hepatorenal insufficiency;
6. Patients with congenital heart disease, implanted pacemaker or defibrillator, artificial heart valve;
7. Failure to perform invasive FFR examination or obtain FFR value due to various reasons;
8. Allergic to β - blockers, nitrates and adenosine, sick sinus syndrome, long QT syndrome, severe hypotension, severe asthma, severe COPD or COPD;
9. Persistent or significant clinical instability, including acute chest pain (sudden onset), cardiogenic shock, blood pressure instability (systolic blood pressure < 90mmHg) and severe congestive heart failure (according to the heart classification of the New York Heart Association, grade III or IV of cardiac function) or acute pulmonary edema;
10. The CTA images of coronary artery showed that the stenosis rate was less than 30% or more than 90%, or the diameter of diseased segment was less than 2.0mm;
11. Ct-ffr can not be calculated because of the quality of CTA image;
12. Known pregnant and lactating women;
13. Having participated in other clinical trials within 3 months;
14. Other situations that the researchers judged were not suitable for inclusion.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The sensitivity and specificity of the test software relative to the gold standard FFR are respectively compared with the preset target value	Screening period, operation date ， 3 days after operation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2020
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): February 15, 2022

Study Registration Dates

• First Submitted: June 7, 2020
• First Submitted That Met QC Criteria: June 7, 2020
• First Posted (ACTUAL): June 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 临2019-0173

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No