Clinical Research Services

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Imaging and Clinical Research Services

Pulse Medical leverages its world-leading computational coronary physiological assessment technology platform and, together with the Cardiology AI Vanguard Club, is dedicated to providing one-stop, high-standard professional services for cardiovascular clinical research worldwide. With a professional team rich in clinical research experience, and built on its proprietary technologies such as μFR, OFR, UFR, and CT-μFR, Pulse Medical offers end-to-end support to partners across three pillars: imaging data analysis, clinical monitoring, and research services.

Imaging Data Analysis Services

Pulse Medical's Core Laboratory has a professional team with extensive experience in imaging data analysis. It has been deeply involved in the data analysis of multiple large-scale RCTs, and provides multimodality imaging data analysis services that meet international standards — covering comprehensive evaluation from CCTA and coronary angiography to intracoronary imaging.

Angio Data (Coronary Angiography)

· μFR Analysis: Angiography-based functional assessment that requires no pressure wire or vasodilator, supporting rapid fractional flow reserve (FFR) computation from single or two angiographic views.
· RWS Analysis: Radial wall strain analysis that reflects plaque vulnerability through the rate of change in vessel diameter.
· AMR Analysis: Angiography-based microvascular resistance analysis for assessing coronary microcirculatory function.
· CFR Analysis: Angiography-based coronary flow reserve assessment.
Virtual Stent Analysis: Adjusting the length and position of a virtual stent to observe residual μFR changes and optimize PCI strategy.
· QCA Analysis: Quantitative coronary angiography analysis providing anatomical parameters such as diameter stenosis, area stenosis, and minimum lumen diameter.
CCTA Data (Coronary Computed Tomography Angiography)

· CT-μFR Analysis: Computes FFR from CCTA images to support the assessment of functionally significant myocardial ischemia prior to invasive coronary angiography.
· Plaque Analysis: Assesses plaque characteristics (calcified, lipid-rich, or fibrous), plaque burden, plaque volume, and plaque angle based on CCTA, generating a 3D plaque view.
· CT-Angio Co-registration: Registers CCTA data with coronary angiography to assist pre-procedural planning and virtual stent positioning for complex lesions such as CTO.
· Fat Attenuation Index (FAI) Analysis: Automatically detects and quantitatively analyzes the pericoronary fat attenuation index for non-invasive assessment of coronary inflammation.
· Coronary Tree 3D Reconstruction and Stenosis Analysis: Generates a 3D coronary tree, automatically identifies lesion locations, and outputs anatomical parameters such as diameter stenosis and area stenosis.
IVUS Data (Intravascular Ultrasound)

· UFR Analysis: IVUS-based FFR computation for integrated anatomical and functional assessment in a single analysis.
· Automated Lumen Segmentation and 3D Reconstruction: AI-based ultra-high-precision recognition of lumen and vessel wall contours with 3D vascular reconstruction.
· IVUS-Angio Co-registration: Registers IVUS data with coronary angiography to assist in localizing stent / balloon landing zones.
· Plaque Characterization: Quantitative analysis of calcific plaque burden, calcification angle, and more.
· Stent Assessment: Quantitative and qualitative evaluation of stent apposition and stent expansion.
OCT Data (Optical Coherence Tomography)

· OFR Analysis: FFR computation based on OCT images, enabling integrated, precise anatomical-and-functional assessment within a single modality.
· Automated Plaque Recognition and Quantification: Based on fully automated AI-based identification of OCT plaque characteristics, it enables quantitative analysis of lipids, fibrous tissue, calcification, macrophages, and other components.
· Automated Lumen / Stent Recognition and 3D Reconstruction: AI-based automatic lumen segmentation and recognition, together with high-precision stent recognition and 3D reconstruction.

Clinical Monitoring Services

Service available in China only

Pulse Medical provides professional CRA (Clinical Research Associate) services covering the full clinical trial lifecycle, ensuring studies strictly comply with China GCP and relevant regulatory requirements.

Site Initiation Phase

Site Initiation Phase

Feasibility survey and site selection; assistance with ethics submission and contract execution; organization of initiation visits and training of the research team on protocol, SOP, informed consent, AE/SAE reporting, and the EDC system; ensuring study materials are delivered on time and in compliance.

Routine Monitoring Phase

Routine Monitoring Phase

Regular site visits with 100% source data verification; monitoring protocol compliance, recording and following up on protocol deviations; ensuring complete documentation and timely reporting of AE/SAE; monitoring the receipt, use, storage, and return of investigational devices; tracking enrollment progress.

Site Close-out Phase

Site Close-out Phase

Completing data cleaning to ensure the database is lockable; retrieving unused materials; archiving all study documents per GCP requirements.

Service Highlights

Service Highlights

All team members are GCP-trained with extensive experience in cardiovascular device clinical trials; full-process management from site selection to close-out.

Research Services

Drawing on the Cardiology AI Vanguard Club and its extensive experience in industry-academia-research-clinic integration, Pulse Medical provides clinical experts with end-to-end research support spanning from study design to translation of outcomes.

Clinical Study Protocol Design

Assists in developing a complete clinical study protocol based on the research objectives, including study background, inclusion / exclusion criteria, study workflow, and endpoint definitions.
Full-Process Clinical Study Management

Provides project management services covering protocol design, ethics submission, study registration, patient enrollment, quality control, and statistical analysis.

Why Choose Pulse Medical

Proprietary Technology Leadership

The sequential coronary physiological assessment technologies μFR, CT-μFR, OFR, and UFR are all world-first innovations, supported by an internationally leading technology platform.

Top-Tier Academic Endorsement

Pulse Medical's technologies have yielded over leading international journals such as The Lancet, NEJM, JACC, and the European Heart Journal, reflecting extensive clinical research experience.

End-to-End Service Capability

Provides one-stop, closed-loop services spanning imaging analysis, clinical monitoring, and research consulting.

Deep Industry-Academia-Research-Clinic Integration

Built on the Cardiology AI Vanguard Club and deep collaboration with top institutions such as the Fuwai Hospital of the Chinese Academy of Medical Sciences, Zhongshan Hospital of Fudan University, and Yale School of Medicine, ensuring the cutting-edge and professional quality of research services.

Contact us to obtain a customized imaging and clinical research service plan.