RecruitingNCT05491668

Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI

Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (REFINE PCI)


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

107 participants

Start Date

Oct 11, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Age >/= 18 years
  • Patient provides written informed consent
  • Clinical presentation with stable coronary artery disease or acute coronary syndromes (unstable angina, Non-ST Elevation Myocardial Infarction (NSTEMI), or ST Elevation Myocardial Infarction (STEMI))
  • Scheduled for clinically indicated cardiac catheterization
  • At least one lesion with angiographic severity visually estimated to be >/= 70% diameter stenosis that is deemed suitable for PCI
  • The operator plans to perform PCI on an ad hoc or planned basis
  • The target lesion is not planned for assessment by invasive physiology

Exclusion Criteria12

  • Failure to provide signed informed consent
  • Culprit vessel of acute ST Elevation Myocardial Infarction (STEMI)
  • Culprit vessel of Non-ST Elevation Myocardial Infarction (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 is 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 <30%
  • Sustained ventricular arrhythmias
  • Patients who are currently pregnant (pregnancy testing will be performed as per standard cardiac catheterization laboratory protocol)

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Interventions

DIAGNOSTIC_TESTNon-hyperemic pressure ratio assessment pre and post PCI

Pre and post PCI invasive physiologic assessment


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT05491668


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