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NCT05491668 · ClinicalTrials.gov registry record

Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI

A clinical trial of Coronary Artery Disease, sponsored by Beth Israel Deaconess Medical Center.

Recruiting
Registry status
107
Enrollment target
1
Study location

NCT05491668 is a study of Coronary Artery Disease that is actively recruiting participants, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 107 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05491668, a study of Coronary Artery Disease, is actively recruiting participants, sponsored by Beth Israel Deaconess Medical Center.

RECRUITING
Registry status
107 participants
Enrollment target
1
Study location

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 Studied

Interventions

  • DIAGNOSTIC_TEST Non-hyperemic pressure ratio assessment pre and post PCI

Study Locations (1)

Massachusetts

  • Beth Israel Deaconess Medical Center - Boston

Trial Details

FieldValue
Enrollment Target 107 participants
Start Date 2022-10-11
Est. Completion 2026-06

What the Registry Record Tells You About NCT05491668

The ClinicalTrials.gov registry entry for NCT05491668 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 107 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (92% lower). The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Non-hyperemic pressure ratio assessment pre and post PCI is the first listed.

NCT05491668 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT05491668 about?

NCT05491668 is a clinical study titled "Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI". 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 c...

What is the current status of trial NCT05491668?

This trial is currently recruiting. The enrollment target is 107 participants. The study started on 2022-10-11. Estimated completion is 2026-06.

What conditions does trial NCT05491668 study?

This clinical trial studies the following conditions: Coronary Artery Disease.

What interventions are being tested in trial NCT05491668?

The interventions under investigation include: Non-hyperemic pressure ratio assessment pre and post PCI (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT05491668?

This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05491668 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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