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New stent aims to tackle tricky heart blockages

NCT ID NCT07649798

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This early study tests a new stent system designed to treat blockages at artery branch points in the heart. It involves 13 people with heart disease who need a procedure to open these blockages. The main goal is to see if the stent can be safely placed and work as intended.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

13 people

The number who actually took part.

Started

Sep 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

21 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: Be 21 years of age or older. Have symptomatic ischemic heart disease or objective evidence of reduced blood flow to the heart. Be eligible for PCI, also known as coronary stenting. Have a new coronary artery narrowing involving a branch point that meets the study's angiographic requirements. Be willing and able to complete study follow-up. Be able to provide written informed consent. If able to become pregnant, have a negative pregnancy test before the procedure and agree not to become pregnant or breastfeed for 1 year. Exclusion Criteria: Are currently participating in another investigational drug or device study that could interfere with this study. Had a coronary intervention within 30 days before the planned study procedure. Need a planned additional coronary procedure soon after the study procedure. Had a prior stent placed close to the target lesion. Have a target lesion that requires certain other treatment devices before stent placement, other than balloon angioplasty or intravascular lithotripsy. Have a serious medical condition that could limit participation, follow-up, or interpretation of the study results. Have a life expectancy of less than 3 years. Have a condition requiring chronic immunosuppressive therapy or have a severe autoimmune or immunosuppressive condition. Have significantly reduced heart pumping function. Had a recent acute heart attack, unless certain laboratory values have returned to acceptable levels. Had a stroke or transient ischemic attack within the past 6 months. Have certain abnormal blood test results, including low white blood cell count, low neutrophil count, low platelet count, or significantly reduced kidney function. Have active stomach or intestinal bleeding, active peptic ulcer disease, a bleeding disorder, or cannot receive blood transfusions. Have a known allergy or contraindication to required medications, contrast dye, or study device materials that cannot be adequately managed. Are pregnant, breastfeeding, or planning to become pregnant within 1 year after the study procedure. Have coronary anatomy that is not suitable for the study device, as determined during coronary angiography (This may include blood clot in the target lesion, severe vessel tortuosity, severe calcification, certain lesion locations, or other significant disease in the target vessel). Are unable or unwilling, in the opinion of the study doctor, to comply with the study requirements.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Cirugía Cardiovascular, Sanatorio Italiano

    Asunción, Paraguay

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