NCT04931771

Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,228 (estimated)
• Sponsor: ECRI bv · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial. A total of 2228 participants will be randomized in a 1:1 fashion to either vFFR- or FFR guided revascularization. Patients will be consented prior to the procedure and then followed up to 12 (+1) months after randomization. The primary endpoint is analyzed at 12 months after randomization. Approximately 35 sites in 7 European countries (Netherlands, Ireland, United Kingdom, Germany, Italy, Spain, and France).

Detailed description

The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial of a vFFR guided strategy as compared to a FFR guided strategy to guide coronary revascularization in 2228 subjects with intermediate coronary artery lesions. Patients are screened for inclusion/exclusion criteria after the indication for coronary catheterization is established. After providing informed consent, patients are enrolled. Randomization is performed in the randomization module of the EDC system with an allocation ratio of 1:1 and stratification by center. The primary endpoint is a composite of all-cause death, any myocardial infarction, or any revascularization at 1 year post-randomization. All deaths and major cardiovascular events, including the individual components of primary and secondary endpoints are adjudicated by an independent Clinical Events Committee (CEC), using standardized definitions. An independent Data and Safety Monitoring Board (DSMB) will formally review the accumulating data to ensure there is no avoidable increased risk for harm to participants. The FAST III trial is performed in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP), ISO 14155:2020, EC requirements and country specific regulations.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	vFFR guided revascularization	3D-angio-based vessel FFR (CAAS, Pie Medical Imaging, Maastricht, The Netherlands) uses 3-Dimensional Quantitative Coronary Angiography (3D-QCA) for functional assessment of coronary stenosis. vFFR is calculated using two angiographic views with at least 30 degrees difference in rotation/angulation to generate the 3D reconstruction of the coronary artery.
DEVICE	FFR guided revascularization	Fractional flow reserve (FFR) is a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis (narrowing, usually due to atherosclerosis) to determine the likelihood that the stenosis impedes oxygen delivery to the heart muscle (myocardial ischemia)

Timeline

• Start date: 2021-11-09
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2021-06-18
• Last updated: 2023-10-18

Locations

43 sites across 7 countries: France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom