NCT04808310

QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to study whether the use of complex 3-dimensional assessment of the severity of a stenosis improves angina and in general cardiovascular outcomes in patients who have residual intermediate coronary artery stenosis following an acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI). Goals of the study are: * To investigate whether decision-making based on quantitative flow reserve (QFR) is associated with a decrease in angina 3 months after an ACS * To investigate whether use of QFR is associated with an improved prognosis.

Detailed description

The study is a single-center, randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions. The primary analysis will be on the per-protocol principle (i.e. including all patients who are not protocol violators). A separate analysis will be performed on an intention-to-treat basis (i.e. all randomized patients randomized to a treatment arm). Primary endpoint 1. Angina questionnaire Secondary endpoints: Number and % of patients undergoing PCI Seattle Angina Questionnaire * SAQ Physical limitation scale * SAQ angina stability scale * SAQ angina frequency scale * SAQ quality of life * SAQ Treatment Satisfaction Disease perception scale Follow-up (3 and 12 months) - Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization) and its components.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Quantitative flow ratio	Quantitative flow ratio (QFR) is a computer method that estimates the hemodynamic relevance of a coronary stenosis based on three-dimensional quantitative coronary angiography (3D QCA)
DIAGNOSTIC_TEST	Assessment of angiographic severity of the stenosis	The indication to coronary stent intervention will be based on angiography

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-04-01
• Completion: 2024-04-17
• First posted: 2021-03-22
• Last updated: 2024-10-08

Locations

1 site across 1 country: Germany