Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Coronary (Artery) Disease
  • Coronary Computed Tomography Angiography
  • Coronary Stenosis
  • Hemodynamics
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 35 years and 85 years
Gender
Both males and females

Description

This study is a prospective and single-center trial in China.It intends to enroll 216 patients with coronary artery disease whose coronary artery is determined to be 30-90% stenosis after coronary CT scan. CT image data will be imported for CT-QFR detection and undergo coronary angiography within 30...

This study is a prospective and single-center trial in China.It intends to enroll 216 patients with coronary artery disease whose coronary artery is determined to be 30-90% stenosis after coronary CT scan. CT image data will be imported for CT-QFR detection and undergo coronary angiography within 30 days. Quantitative analysis of coronary angiography (QCA) was performed with the degree of coronary stenosis. FFR and QFR were detected during the operation. Use FFR as a reference standard to verify the diagnostic performance of CT-QFR and QFR. The primary endpoint is the diagnostic accuracy of CT-QFR in identifying hemodynamically significant coronary stenosis with FFR as the reference standard. Major secondary endpoint is the non-inferiority of CT-QFR compared with QFR in the patients without extensively calcified lesions. The completion of the project will provide patients with a practical non-invasive assessment method of coronary heart disease which provides the best treatment strategy.

Tracking Information

NCT #
NCT04665817
Collaborators
Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Investigators
Not Provided