Clinical Outcomes of CT-FFR Versus QFR-guided Strategy for Decision-Making in Patients With Stable Chest Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital

About this trial

This study is a multicenter, prospective, blinded (blinding of clinical evaluators), randomized controlled, event-driven non-inferiority clinical trial. Eligible subjects who meet the inclusion criteria will be registered in the central randomization system and randomized in a 1:1 ratio to either the experimental group (CT-FFR guided group) or the control group (QFR guided group).

Eligibility criteria

Qualifiers

Age ≥18 years

with stable chest pain who underwent CCTA and have at least 1 lesion with a percent diameter stenosis (DS%) between 50% and 90% in a coronary artery with a ≥2.5 mm reference vessel diameter by visual assessment.These patients plan to undergo further non-invasive or invasive diagnosis and treatment.

Able to undergo invasive coronary angiography (ICA)

Capable of complying with the study procedures and fully understand the informed consent form approved by the ethics committee, and provide voluntary consent.

Disqualifiers

Patients with acute coronary syndrome requiring urgent revascularization.

Patients with unstable angina, including those with first-onset chest pain within 48 hours, CCS III or higher first-onset angina, those whose angina has worsened to CCS III or IV within a short period of time, or those with rest angina lasting more than 20 minutes.

Patients with iodine contrast agent allergy.

Pregnant or lactating women.

Trial design

Treatments tested in this trial

  • CT-FFR
  • QFR

Treatment groups

4,648 Participants
are divided into 2 treatment groups

Sponsors and collaborators