Percutaneous Coronary Intervention (PCI) Clinical Trials

Clinical trials related to Percutaneous Coronary Intervention (PCI) Procedure

Diagnostic Accuracy of Intravascular Ultrasound-Derived Fractional Flow Reserve for Online Assessment of Functionally Significant Coronary Stenosis: A Multicenter Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age Diagnosed with stable/unstable angina or post-acute phase myocardial infarction (\>72 hours after onset) Able to comprehend study design and provide written informed consent Angiographic \& IVUS-Specific Requirements

Locations
Other Locations
China
Fuwai hospital
RECRUITING
Beijing
Contact Information
Primary
Kefei Dou, Principal Investigator
drdoukefei@126.com
15980609858
Backup
Zhihao Zheng, MD
fwzh97@126.com
15980609858
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 292
Treatments
Experimental: IVUS-FFR Online Assessment
Intervention Protocol~Participants receive a real-time functional coronary evaluation using the integrated IVUS-FFR system during diagnostic angiography. The procedure consists of three sequential phases:~IVUS Image Acquisition A clinically approved IVUS catheter (40MHz frequency) is advanced to the target coronary segment Standardized automated pullback (0.5 mm/sec) captures cross-sectional vessel images Minimum imaging length: 30mm proximal-to-distal to stenosis Real-Time Computational Analysis DICOM data transfer to IVUS-FFR processing platform~AI-driven segmentation of:~Lumen boundaries External elastic lamina (EEL) Plaque morphology~Hemodynamic simulation using:~Adaptive blood flow models based on Murray's law Branching-specific flow distribution algorithms Processing time: ≤90 seconds Diagnostic Output Delivery Primary metric: Computed IVUS-FFR value (scale 0-1) Clinical threshold: IVUS-FFR ≤0.80 = hemodynamically significant stenosis Quality control: Auto
Sponsors
Leads: China National Center for Cardiovascular Diseases

This content was sourced from clinicaltrials.gov