Actively Recruiting

Age: 20Years +
All Genders
NCT07151976

Thrombus Aspiration and Pathology and OCT Study

Led by Fujita Health University · Updated on 2026-02-05

200

Participants Needed

1

Research Sites

600 weeks

Total Duration

On this page

Sponsors

F

Fujita Health University

Lead Sponsor

F

Fondazione IRCCS Policlinico San Matteo di Pavia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Most acute coronary syndromes (ACS) are caused by plaque complications triggering thrombotic events in the culprit plaques. Plaque complications include plaque rupture (Ruptured Fibrous Cap-RFC) with exposure of highly thrombogenic substrate to the flow and plaque erosion (Intact Fibrous Cap-IFC) a condition characterized by endothelial/intimal damage occurring over non-ruptured plaques. Far less commonly (\<5%), calcified nodules (CN) may trigger acute coronary thrombosis. Plaque rupture accounts for 75% of fatal AMI in autopsy series, while erosion is found in about 25% of cases. These proportions have been supported by in vivo invasive studies (OCT) and OCT-pathology correlation studies. However, it remains unclear whether OCT findings consistently align with in vivo pathology-based evidence of RFC in ACS. Guidelines addressing treatments of ACS unanimously indicate percutaneous coronary intervention (PCI) to restore the coronary flow. Pre-PCI thrombus aspiration is not currently indicated by most guidelines, with the exception of cases with very high thrombus burden. The samples retrieved from thrombus aspiration can be suitable for pathology investigation and aim to evaluate the presence of plaque components in the context of the thrombotic material, a finding that demonstrates plaque rupture as the substrate for the acute coronary event. These studies are uniquely qualified to provide information on the correct OCT-based interpretation of plaque complications in ACS and require OCT imaging quality suitable to classify RFC, IFC, and CN. Therefore, a prospective OCT-pathology study was designed using the pre-PCI aspirated material from patients with high thrombus burden, to explore the contribution of pathology study in OCT-based classification of plaque complications.

CONDITIONS

Official Title

Thrombus Aspiration and Pathology and OCT Study

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with acute coronary syndrome showing STEMI or NSTEMI
  • Only native coronary artery lesions included
  • OCT imaging performed prospectively with both thrombus aspiration and OCT observations available
  • Written informed consent provided for procedure, follow-up, and data use
Not Eligible

You will not qualify if you...

  • Patients with cardiogenic shock or contraindications to anticoagulation and anti-platelet therapy
  • Lesions in tortuous vessels, ostial segment, or left main stem excluded due to imaging difficulty

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fujita Health University

Toyoake, Aichi-ken, Japan, 470-1192

Actively Recruiting

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Research Team

Y

Yukio Ozaki, MD, PhD

CONTACT

R

Reina Ozaki, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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