Actively Recruiting

Age: 18Years +
All Genders
NCT05491668

Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI

Led by Beth Israel Deaconess Medical Center · Updated on 2025-03-28

107

Participants Needed

1

Research Sites

189 weeks

Total Duration

On this page

Sponsors

B

Beth Israel Deaconess Medical Center

Lead Sponsor

O

Opsens, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Traditionally, the severity of a blockage (stenosis) in a coronary artery has been determined by visual angiographic assessment of the diameter of the artery at the level of a blockage compared to a normal healthy area of the same artery. With the advent of invasive physiological testing to assess coronary blood flow, multiple clinical trials have demonstrated a clinical benefit to a physiology-guided percutaneous coronary intervention (PCI) approach. However, despite this and the potential for significant variation in the interpretation of coronary artery stenosis severity by visual angiography alone to guide PCI, invasive physiologic indices remain significantly under-utilized. The purpose of this study is to investigate the physiologic significance of coronary lesions deemed angiographically severe by visual estimation that are planned for PCI. The investigators plan to perform blinded physiologic assessment pre and post PCI. The primary aim of the study is to determine whether a subset of lesions visually estimated as severe by angiography treated with stent placement/PCI may in fact not be physiologically significant when assessed invasively, and thus PCI could safely be deferred in these patients. A secondary aim is to evaluate physiologic assessment post PCI to detect residual ischemia that could be utilized to optimize stent placement.

CONDITIONS

Official Title

Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Patient provides written informed consent
  • Clinical presentation with stable coronary artery disease or acute coronary syndromes (unstable angina, NSTEMI, or STEMI)
  • Scheduled for clinically indicated cardiac catheterization
  • At least one lesion with angiographic severity visually estimated to be 70% or more diameter stenosis suitable for PCI
  • Operator plans to perform PCI on an ad hoc or planned basis
  • Target lesion is not planned for assessment by invasive physiology
Not Eligible

You will not qualify if you...

  • Failure to provide signed informed consent
  • Culprit vessel of acute STEMI
  • Culprit vessel of NSTEMI
  • Thrombolysis In Myocardial Infarction (TIMI) flow less than grade 3 at baseline or visible thrombus
  • Chronic total occlusion (CTO) in the target vessel
  • Target vessel supplied by major collaterals or supplies major collaterals to a CTO
  • Target lesion involves the left main coronary artery
  • Prior history of coronary artery bypass grafting (CABG) to the target vessel, except if bypass graft is occluded
  • Previously known untreated severe valvular heart disease
  • Previously known left ventricular ejection fraction below 30%
  • Sustained ventricular arrhythmias
  • Currently pregnant (pregnancy testing performed per standard protocol)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

E

Eric Osborn, MD, PhD

CONTACT

K

Killian McCarthy, MB, BCh, BAO

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

1

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