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New camera inside heart arteries could improve stent placement

NCT ID NCT07182799

Diagnosis Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether using a special camera called optical coherence tomography (OCT) during heart artery procedures helps doctors make better decisions and get better results. About 3,200 people with various heart conditions will be included. The goal is to see if OCT guidance reduces the risk of heart-related death, heart attacks, or the need for repeat procedures.

What this could mean

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

Active substance
optical coherence tomography (OCT) imaging
What this could lead to
If successful, this could show that using OCT during heart procedures leads to better treatment decisions and fewer future heart events.
What could go wrong
This is an observational registry, not a controlled trial, so it can't prove cause and effect. Results may not apply to all patients or hospitals.

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 3,200 people

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

Started

Sep 2025

Expected to finish

Sep 2036

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

All subjects over 18 years who are undergoing an OCT coronary assessment during clinically indicated coronary angiogram regardless of the clinical syndrome (silent ischemia, effort angina or acute coronary syndrome).

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 over 18 years; * Patients with clinical indication to coronary angiography undergoing intra-procedural OCT regardless of the clinical syndrome; * Patients with at least one end-procedural OCT assessment with a sufficient acquisition length to address the whole length of plaque or stented segments plus the proximal and distal reference segments; * Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the Ethical Committee of the respective clinical site. Exclusion Criteria: * Female with childbearing potential or lactating; * Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl and/or glomerular filtration rate \<30 ml/min); * Advanced heart failure (NYHA III-IV); * Previous heart transplantation; * Co-morbidities that could interfere with completion of study procedures, or life expectancy less than 1 year; * Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study; * Heavily calcified lesion or tortuous vessel which cannot be successfully imaged by OCT; * Lesion located at the coronary ostium or in angulated (\>70°), sharp take-off vessel;

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder coronary microvascular disorder coronary restenosis MINOCA

As listed by the trial registrant

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

Acute coronary syndromes (ACS) Chronic coronary syndrome Clinical outcome Coronary stent implantation Inoca (ischemia with non obstructive coronary artery disease) MINOCA Percutaneous coronary intervention (PCI) Stent restenosis Stent thrombosis

Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

    Rome, 00168, Italy

More trials for these conditions

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