IVUS-FFR Accuracy for Coronary Stenosis

Summary

IVUS-FFR Online Accuracy for Coronary Stenosis What is this study testing? This study is testing a new technology called IVUS-FFR , which uses ultrasound imaging inside heart arteries (IVUS) to quickly measure whether a narrowed artery ( coronary stenosis ) is reducing blood flow. Unlike the current standard test (FFR), this new method doesn't require extra wires or medication to work.

Why is this important?

Many patients with heart artery narrowing need tests to decide if a stent is necessary.

Current FFR tests involve inserting a pressure wire and giving medication (like adenosine) that can cause discomfort.

IVUS-FFR could provide equally accurate results faster, cheaper, and more comfortably .

What happens in the study?

If you join:

Standard heart artery imaging (angiogram) will be performed. An ultrasound probe (IVUS) will be moved through the artery to create detailed images.

The new IVUS-FFR software will analyze these images immediately to estimate blood flow.

For comparison, a standard FFR test (with pressure wire and medication) will also be done.

All steps use existing approved devices and take \<10 extra minutes. Who can participate?

Adults (≥18 years) with:

Suspected or known heart artery disease At least one artery narrowing (30%-90% blocked) Excluded: Recent heart attack (\<72 hrs), severe kidney/heart failure, or pregnancy.

What are the risks and benefits?

Risks: Same as routine heart catheterization (bleeding, infection, artery injury). The IVUS and FFR steps add minimal extra risk.

Benefits: No direct benefit, but results may improve future care by reducing need for invasive tests.

Study goal:

To validate if IVUS-FFR is as accurate as the current FFR standard in 292 patients across multiple hospitals in China.

Who is running the study? Led by heart specialists at Fuwai Hospital (Beijing) - China's top cardiovascular center - with ethics committee oversight.

Conditions

• Percutaneous Coronary Intervention
• Intravenous Ultrasound
• Coronary Physiology

Interventions

DIAGNOSTIC_TEST

Ultrasound-Derived Fractional Flow Reserve Computational System

1. Core Technological Innovation This diagnostic system revolutionizes coronary stenosis assessment by integrating intravascular ultrasound (IVUS) imaging with real-time computational physiology . Its proprietary technology features: AI-driven vessel segmentation : Deep neural networks automatically delineate lumen boundaries and external elastic lamina from IVUS images, enabling millimeter-level precision in 3D coronary reconstruction. Dynamic hemodynamic modeling : Adaptive algorithms apply Murray's law to calculate branch-specific blood flow distribution, accounting for plaque composition (calcified/fibrous/lipidic) and vessel tapering. 2. Procedural Implementation The intervention seamlessly integrates into standard coronary angiography workflows: Image acquisition : A 40MHz IVUS catheter performs automated pullback (0.5 mm/sec) across the target stenosis and adjacent segments. Real-time processing : DICOM data transfers to an embedded GPU server, initiat

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases

  lead OTHER_GOV

Principal Investigators

• Kefei Dou, MD · Chinese Academy of Medical Sciences and Peking Union Medical College

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-01

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• China

Study Locations