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Balloon that delivers medicine directly to heart arteries could offer Stent-Free option

NCT ID NCT04470934

Disease control Sponsor: B. Braun Melsungen AG 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This study evaluates a special balloon coated with sirolimus, a drug that helps prevent arteries from narrowing again after angioplasty. The balloon is used during routine procedures to open blocked heart arteries in people with coronary artery disease. Researchers are tracking how well it works and its safety in real-world use, focusing on whether it reduces heart attacks or the need for repeat treatments.

What this could mean

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

Active substance
a sirolimus-coated balloon catheter that delivers the drug directly to the artery wall during angioplasty
What this could lead to
If successful, this could offer a stent-free option for treating coronary artery disease, reducing the need for repeat procedures.
What could go wrong
This is an observational study without a comparison group, so results may not prove superiority over existing treatments. Risks include artery injury, blood clots, or the drug not preventing re-narrowing as expected.

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 1,302 people

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

Started

Apr 2021

Expected to finish

Mar 2027

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

This is a single-armed, prospective, international, multi-center, post-market study in patients with coronary artery disease and indication for PCI either due to anginal symptoms and a relevant stenotic coronary lesion during angiography or due to documented ischemia by non-invasive or invasive functional testing. All patients who undergo a target intervention with the SCB will be followed for 12 and 24 months after initial PCI.

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: * All common significant coronary lesions * Target lesion length \>34mm need to be covered with at least 2 devices * Patients eligible for this study must be at least 18 years of age * The patient must fulfil the standard recommendations for percutaneous coronary intervention (PCI), based on the last ESC recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment Exclusion Criteria: * Intolerance to sirolimus * Allergy to components of the coating * Pregnancy and lactation * Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized * Cardiogenic shock * Risk of an intraluminal thrombus * Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy * Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior * Severe allergy to contrast media * Lesions which are untreatable with PCI or other interventional techniques * Patients with an ejection fraction of \< 30 % * Vascular reference diameter \< 2.00 mm * Treatment of the left stem (first section of the left coronary artery) * Indication for a bypass surgery * Contraindication for whichever accompanying medication is necessary

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Conditions

The condition(s) this trial relates to.

coronary artery disorder myocardial ischemia

As listed by the trial registrant

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

Coronary artery disease Myocardial ischaemia

Contacts and locations

Locations

  • Universitätsklinikum Jena

    Jena, Thuringia, 07747, Germany

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