Evaluating a new method for assessing coronary artery blockage

A Prospective, Multicenter, Blinded, Randomized, Noninferiority Clinical Trial of Coronary Angiography Fractional Flow Reserve (caFFR) Versus Fractional Flow Reserve (FFR) to Guide Percutaneous Coronary Intervention（Flash FFR Ⅱ ）

This study is testing a new way to check for heart artery blockages to see if it works just as well and is more cost-effective than the traditional method for patients needing heart procedures.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2132 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 13 sites (Peking, Beijing and 12 other locations)
• Trial ID: NCT04575207 on ClinicalTrials.gov

What this trial studies

The Flash FFR Ⅱ study investigates the effectiveness and cost benefits of using coronary angiography-derived fractional flow reserve (caFFR) compared to traditional fractional flow reserve (FFR) measured by a pressure wire in guiding percutaneous coronary interventions (PCI) for patients with moderate coronary artery stenosis. This multicenter, randomized, non-inferiority trial will include eligible patients who will be assigned to either the caFFR-guided or FFR-guided group. The study aims to collect data on major cardiovascular adverse events (MACE) and cost-effectiveness over a two-year follow-up period. Subgroup analyses will also be conducted to explore various patient characteristics and outcomes.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with moderate coronary artery stenosis who require angiography and possible PCI.

Not a fit: Patients with severe coronary artery stenosis or those not requiring PCI may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more cost-effective and efficient method for assessing coronary artery stenosis, potentially improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using similar approaches, but this specific method is being evaluated for its non-inferiority, making it a novel investigation.

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.

Where this trial is running

Peking, Beijing and 12 other locations

• Beijing Hospital of Traditional Chinese Medicine, Capital Medical University — Peking, Beijing, China (Recruiting)
• Peking University People's Hospital — Peking, Beijing, China (Recruiting)
• Xiamen Cardiovascular Hospital Xiamen University — Xiamen, Fujian, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Completed)
• The University of Hong Kong Shenzhen hospital — Shenzhen, Guangdong, China (Recruiting)
• The People's Hospital of Hebi — Hebi, Henan, China (Recruiting)
• The First Affiliated Hospital of Xinxiang Medical College — Xinxiang, Henan, China (Recruiting)
• Jiangxi Provincial People's Hospital — Nanchang, Jiangxi, China (Recruiting)
• QILU Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
• Zhongshan Hospital affiliated to Fudan University — Shanghai, Shanghai, China (Recruiting)
• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Affiliated Hospital of Yunnan University — Kunming, Yunnan, China (Recruiting)
• Department of Cardiology, Peking University First Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yanjun Gong, MD

Conditions Coronary Artery Disease; Coronary Stenosis; Myocardial Ischaemia; Coronary Circulation; Stable Angina Pectoris; Unstable Angina Pectoris; Asymptomatic Ischemia; Acute Myocardial Infarction