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Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI

NCT05491668 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 107

Last updated 2025-03-28

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Non-hyperemic pressure ratio assessment pre and post PCI

Pre and post PCI invasive physiologic assessment

Sponsors & Collaborators

Principal Investigators

  • Eric Osborn, MD, PhD · Beth Israel Deaconess Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-11
Primary Completion
2025-12-31
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491668 on ClinicalTrials.gov