Coronary Artery Disease Clinical Trial
Official title:
Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
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).
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |