The Flash FFR Ⅱ Study

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Sep 29, 2020

Keywords

ClinConnect Summary

The Flash FFR Ⅱ Study is exploring a new method to help doctors decide the best treatment for patients with moderate coronary artery disease, which can cause chest pain and other heart-related issues. Specifically, the study is comparing two techniques: one that uses special imaging from an angiogram (a type of X-ray of the heart arteries) to measure blood flow, and another that uses a pressure wire to get similar measurements. The goal is to see if the imaging method is just as effective and cost-efficient in guiding a procedure known as percutaneous coronary intervention (PCI), which is a way to open narrowed heart arteries.

To participate in this study, individuals need to be at least 18 years old and have signs of coronary heart disease, such as stable or unstable angina (chest pain). They must also need an angiogram and potentially a PCI procedure. However, there are some important criteria that would exclude them from participation, like having certain serious heart conditions or recent heart attacks. If eligible, participants can expect to have their blood flow measured using the imaging technique and may undergo PCI if needed. This study is currently recruiting participants, and anyone who joins will be contributing to important research that could improve heart care in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * General inclusion criteria:
• • 1. Age above 18 years old, no limit on the gender;
• • 2. Angiography is considered necessary and feasible by investigator, and PCI will be performed if necessary;
• • 3. Suspected coronary heart disease, stable angina pectoris, unstable angina pectoris, non-culprit vascular assessment in participants with acute non-ST-segment elevation myocardial infarction, and non-culprit vascular assessment in patients with previous ST-segment elevation acute myocardial infarction;
• • 4. Participants voluntarily participate in this clinical trial and sign informed consent form.
• * Coronary angiography inclusion criteria:
• The presence of at least one stenosis and meets the following imaging findings:
• • 1. The degree of coronary artery stenosis≥50% and ≤90% by visual measurement;
• • 2. The reference diameter of the stenotic segment≥2.25 mm by visual measurement;
• • 3. The investigator visually observes the target vessel through angiographic images, and consider that PCI surgery is technically feasible.
• Exclusion Criteria:
• * General exclusion criteria:
• • 1. Acute ST-segment elevation myocardial infarction within 6 days;
• • 2. Cardiogenic shock or left ventricular ejection fraction≤50%;
• • 3. eGFR \< 30 mL/min (1.73 m2);
• • 4. Severe coagulation dysfunctions or bleeding disorders;
• • 5. Allergic to iodine contrast medium or contraindications for adenosine administration;
• • 6. Severe aortic stenosis;
• • 7. Life expectancy less than 1 year;
• • 8. Pregnant women or women planning a recent pregnancy;
• • 9. Participation in any other clinical trials of devices or drugs (ongoing or within the past 1 month);
• • 10. The investigator believes that the particitant has other conditions that are not suitable for clinical trials.
• * Coronary angiography exclusion criteria:
• • 1. TIMI flow in the target vessel\<grade III ;
• • 2. Presence of myocardial bridge and systolic compression ≥50% in the target vessel;
• • 3. Presence of artificial bypass in the target vessel;
• • 4. Left main coronary artery or right coronary artery ostial lesions;
• • 5. Stent implantation in the target vessel within 3 months;
• • 6. Target vessel provides collateral support to chronically total occluded vessels;
• • 7. Presence of factors affecting angiographic analysis and stenosis visualization, including incomplete vessel opacification, or overlap with other coronary branches of extreme vessel foreshortening.