Obstacles Hindering Optical Coherence Tomography Adoption in Coronary Care Settings

Clinical teams worldwide are looking toward advanced imaging modalities, yet Optical Coherence Tomography (OCT) faces hurdles in penetrating coronary care practices. A new clinical trial, sponsored by Consorzio Futuro in Ricerca and registered under NCT07193693, aims to investigate barriers limiting OCT application in the diagnosis and treatment of coronary artery disease (CAD). Slated to commence recruitment, this study could reshape clinical adoption strategies for OCT.

In this article

What challenges are limiting OCT adoption?

The clinical trial seeks to pinpoint technical, regulatory, and practical barriers that prevent wider adoption of OCT for patients with coronary artery disease (CAD). Early reports highlight concerns such as:

  • High operational costs of OCT compared to alternative imaging technologies.
  • Complexity in integrating OCT devices into existing workflows.
  • Unfamiliarity among clinicians regarding OCT capabilities and performance metrics.

Investigators hope to establish data-backed solutions to inform policy makers, manufacturers, and healthcare practitioners about overcoming these barriers.

What is the clinical context for OCT in CAD management?

OCT provides high-resolution cross-sectional imaging of coronary vessels, allowing for detailed assessment of plaque morphology, vessel size, and treatment response. Despite its innovative edge, OCT is underutilized in diagnosing conditions like angina, myocardial infarction, and atherosclerotic heart disease (ASHD). Contrast agents, specialized probes, and interpretation complexity add layers of challenges.

The insights gained from this trial could redefine how OCT is positioned against widely adopted methods such as intravascular ultrasound (IVUS) and angiography.

Frequently asked questions

  1. Why is OCT important in coronary care?
    OCT offers unparalleled imaging resolution, permitting precise diagnoses and informing tailored treatment plans.
  2. What conditions are being studied?
    The trial focuses on coronary artery diseases such as angina, myocardial infarction, and atherosclerotic heart disease.
  3. Who sponsors this trial?
    It is sponsored by Consorzio Futuro in Ricerca.
  4. When will recruitment begin?
    The trial is not yet recruiting as of this publication date: September 30, 2025.

What actions should stakeholders consider?

Regulatory, clinical, and quality teams should monitor this trial closely for actionable outcomes. Industry stakeholders might consider investing in clinician education around OCT’s advantages while policymakers evaluate cost-benefit analyses to encourage wider device adoption.

Disclaimer

This content is for informational purposes only. It does not constitute legal or regulatory advice. Consult your regulatory advisors for compliance guidance specific to your organization.

Clinical trial details

For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07193693?term=medical+device