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New stent aims to tackle tough heart blockages

NCT ID NCT05658250

Disease control Sponsor: Yonsei University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study is testing a special drug-coated stent called Cre8 in 300 people with long blockages (at least 30 mm) in their heart arteries. The stent releases a medicine to help keep the artery open. Researchers are watching to see if it is safe and effective, looking for problems like heart attacks or the need for another procedure.

What this could mean

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

Active substance
CRE8 polymer-free amphilimus-eluting stent
What this could lead to
If successful, this could offer a better treatment option for people with long blockages in heart arteries, potentially reducing the need for repeat procedures.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The stent may still carry risks like blood clots or re-narrowing of the artery.

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 300 people

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

Started

Aug 2021

Expected to finish

Dec 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

300 patients underwent Cre 8 stent, Cre8 evo stent implantation of 30 mm or more

Ages

19 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. 19 years of age or older 2. Clinical evidence of coronary artery disease, including asymptomatic ischemia, stable angina, and acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, ST-segment elevation myocardial infarction) 3. Coronary artery lesion length 30 mm or more 4. Those who voluntarily agreed in writing to participate in this clinical study Exclusion Criteria: 1. Remaining life expectancy is less than 1 year 2. Subjects with known hypersensitivity or contraindication to the following drugs or substances: heparin, aspirin, clopidogrel, prasugrel, ticagrelor 3. In case the other researcher judges that it is inappropriate to participate in this study (pregnant women, the elderly, etc.)

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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 Drug-eluting stent

Contacts and locations

Locations

  • Yongin Severance Hospital

    Yongin, Gyeonggi-do, 16995, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.