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

Launched by ECRI BV · Jun 11, 2021

Keywords

ClinConnect Summary

The FAST III trial is studying two different ways to guide a medical procedure called revascularization, which helps improve blood flow in patients with coronary artery disease. Specifically, it compares two techniques: one using a technology called vessel fractional flow reserve (vFFR) and the other using traditional fractional flow reserve (FFR). This trial involves 2,228 participants from various hospitals across seven European countries, and each participant will be followed for up to 12 months to see how well these methods work.

To be eligible for this trial, participants need to be at least 18 years old and have certain heart conditions, such as stable angina (chest pain) or silent ischemia (lack of blood flow without symptoms). They should also have narrowing in their coronary arteries that isn't clearly severe. Participants will be informed about the study's risks and benefits and must agree to take part before any procedures are done. Throughout the study, patients can expect regular check-ins to monitor their health and the effectiveness of the treatment received. This trial is currently recruiting participants, and it's important to note that those with certain severe heart conditions or other specific health issues may not be eligible to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The patient must be ≥18 years of age
• • 2. Presenting with silent ischemia, stable angina, or non-ST-elevation acute coronary syndrome (NSTE-ACS)
• • 3. Coronary artery disease with at least one native artery in which the stenosis severity is questionable (typically 30-80% stenosis)
• • 4. FFR assessment and vFFR assessment feasible
• • 5. The patient is willing and able to cooperate with study procedures and follow-up until study completion
• • 6. Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee
• Exclusion Criteria:
• • 1. ST-elevation myocardial infarction (STEMI) at presentation
• • 2. Cardiogenic shock or severe hemodynamic instability at the time of intervention (heart rate\<50 beats per minute, systolic blood pressure \<90mmHg) or use of left ventricular assist device
• • 3. Any target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow \<3.
• • 4. Presence of thrombus in intermediate target lesion.
• • 5. Known untreated severe valvular heart disease
• • 6. Target lesion is located in or supplied by an arterial or venous bypass graft
• • 7. History of cardiac allograft transplantation
• • 8. Aorto-ostial lesions with an estimated diameter stenosis \>50%
• • 9. Severe tortuosity precluding the acquisitions of 2 orthogonal projections of the target vessel with minimal overlap or foreshortening.
• • 10. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or adenosine
• • 11. Non-cardiac co-morbidities with a life expectancy less than 1 year
• • 12. Currently participating in another trial that is not yet at its primary endpoint. The patient is not allowed to participate in another investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study
• • 13. Women of childbearing potential who do not have a negative pregnancy test within 24 hours before the procedure
• • 14. Subject belongs to a vulnerable population (per Investigator's judgment) or subject unable to read or write