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The Flash FFR Ⅱ Study

NCT04575207 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2132

Last updated 2023-03-21

No results posted yet for this study

Summary

The overall purpose of Flash FFR Ⅱ is to investigate whether coronary angiography-derived fractional flow reserve (caFFR), compared with fractional flow reserve (FFR) measured by a pressure wire, has non-inferior clinical effect and cost benefit in guiding the percutaneous coronary intervention (PCI) for patients with moderate coronary artery stenosis in terms of long-term clinical prognosis.

Conditions

  • Coronary Artery Disease
  • Coronary Stenosis
  • Myocardial Ischaemia
  • Coronary Circulation
  • Stable Angina Pectoris
  • Unstable Angina Pectoris
  • Asymptomatic Ischemia
  • Acute Myocardial Infarction
  • Percutaneous Coronary Intervention

Interventions

DIAGNOSTIC_TEST

caFFR

caFFR is a new index of physiological assessment of coronary artery stenosis severity, based on angiographic images. Through two-dimensional analysis and three-dimensional reconstruction of two coronary angiography image series with an angle-off \> 30 degrees, combined with fluid mechanics, TIMI frame counting method, and optimized CFD algorithm, the pressure drop from coronary ostium to every point in the vessel can be obtained, and then the caFFR value of each point in the vessel can be computed. The cutoff value in this trial is caFFR ≤ 0.80 for myocardial ischemia.

DIAGNOSTIC_TEST

FFR

FFR is a widely used, pressure-based functional assessment index of coronary stenoses obtained with an intracoronary pressure wire fitted with pressure sensors. The pressure wire passes through the stenosis and directly measures the pressure distal to the stenosis. FFR value can be obtained by combining the pressure at the coronary ostium and the distal pressure to the stenosis. The cutoff value in this trial is FFR ≤ 0.80 for myocardial ischemia.

Sponsors & Collaborators

  • Rainmed Ltd., Suzhou, China

    collaborator UNKNOWN

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Yong Huo, MD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-12
Primary Completion
2023-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575207 on ClinicalTrials.gov