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Heart stent study aims to cut unnecessary procedures with a simple wire test

NCT ID NCT05491668

Diagnosis Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing whether a thin wire that measures blood flow in heart arteries can help doctors decide which blockages truly need a stent. About 107 people with severe-looking blockages will have the wire test before and after stent placement. The goal is to see if some blockages that look severe on an X-ray are actually not limiting blood flow, so stents could be safely avoided.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OpSens OptoWire III (diagnostic wire)
What this could lead to
If successful, this could help doctors avoid unnecessary stents in patients whose blockages are not actually limiting blood flow, reducing risks and costs.
What could go wrong
This is a small, early-stage study (107 people) that only measures outcomes at 30 days. The wire may not change long-term outcomes, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 107 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Study population will consist of male and female subjects from the general interventional cardiology population who are scheduled for coronary angiogram at Beth Israel Deaconess Medical Center

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

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