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New balloon treatment could unclog tiny heart arteries without stents

NCT ID NCT07158307

Disease control Sponsor: Genoss Co., Ltd. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study is testing a special balloon coated with a drug (paclitaxel) and natural substances (shellac and vitamin E) to treat small coronary artery disease. The balloon is inflated inside the narrowed artery to deliver the drug and help keep it open. Researchers will follow 3,000 adults for several years to see if this approach reduces heart-related complications like heart attack 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
paclitaxel-coated balloon catheter with shellac and vitamin E
What this could lead to
If successful, this could provide a safer, effective way to treat small coronary artery disease without permanent implants like stents.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. Risks include vessel injury or incomplete opening.

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 3,000 people

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

Started

Jun 2024

Expected to finish

Jun 2031

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.

Who is studied

Subjects who underwent PCI with GENOSS DCB for small coronary artery disease with de novo lesions

Ages

19 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: * Adults over the age of 19 * Patients with new lesions with coronary small vascular disease (vascular diameter \<3.0 mm) underwent a GENOSS® DCB procedure through percutaneous coronary intervention * Subjects who agreed to the clinical research plan and the clinical follow-up plan, voluntarily decided to participate in this clinical study, and agreed in writing to the consent of the study subjects Exclusion Criteria: * Subjects who plan to become pregnant during the period of this study as women of the gestational age * Subjects whose remaining life expectancy is expected to be less than one year * Subjects who visited the hospital due to psychogenic shock at the time of visiting the hospital and are predicted to have a low chance of survival based on medical judgment * If it falls under any of the following items after prior dilation of the target lesion; * Stent procedures are required due to vascular detachment that limits blood flow * If the residual stenosis is \>30% * If the TIMI flow is \<3 * Subjects participating in a randomized study of medical devices * If the researcher determines that it is not appropriate for this clinical study or may increase the risk associated with participation in the study

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary microvascular disorder

As listed by the trial registrant

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

Coronary artery disease (CAD)

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Ulsan University Hospital

    Ulsan, 44033, South Korea

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