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New balloon treatment for clogged arteries shows promise

NCT ID NCT07326735

Disease control Sponsor: Frisch Medical Device Private Limited 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026

Summary

This study tested a special balloon coated with sirolimus, a drug that helps keep heart arteries open after a blockage is cleared. 360 adults with coronary artery disease were treated and followed for 12 months to see if the balloon reduced major heart problems like heart attack or the need for another procedure. The goal was to see if this balloon is a safe and effective option for managing heart disease.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

360 people

The number who actually took part.

Started

Jan 2023

Finished

Mar 2024

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Age 18 years or older. 2. Patient diagnosed with obstructive coronary artery disease suitable for percutaneous coronary intervention. 3. Target lesion located in a native coronary artery with reference vessel diameter of ≥2.0 mm. 4. Successful lesion preparation prior to DCB treatment (defined by \<30% residual stenosis and TIMI flow ≥2). 5. Patient able and willing to comply with scheduled follow-up evaluations at 1, 6, and 12 months. 6. Signed informed consent obtained prior to the procedure. Exclusion Criteria: 1. ST-elevation myocardial infarction (STEMI) within the previous 48 hours. 2. Left main disease \>50% requiring stenting or surgical intervention. 3. Presence of thrombus or severe vessel calcification that prevents adequate balloon expansion. 4. Previous stenting at the target lesion within the previous 3 months. 5. Known allergy or contraindication to sirolimus, contrast media, or dual antiplatelet therapy. 6. Pregnant or breastfeeding women. 7. Life expectan

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Conditions

The condition(s) this trial relates to.

Angina Pectoris Color Vision Defects coronary artery disorder myocardial infarction

As listed by the trial registrant

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

Coronary artery disease (CAD) (E.G., angina, myocardial infarction, and atherosclerotic heart disease (ASHD))

Contacts and locations

Locations

  • National Heart Centre Malaysia

    Kuala Lumpur, Malaysia

  • Prime Heart Institute

    Yangon, Gujarat, 380052, Burma

More trials for these conditions

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