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Drug-Coated balloon for clogged arteries under Long-Term review

NCT ID NCT06678490

Disease control Sponsor: OrbusNeich 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is tracking 282 patients with coronary artery disease who received a paclitaxel-coated balloon catheter (Support C DCB) during routine care. Researchers are monitoring for heart-related events like cardiac death, heart attack, or the need for repeat procedures over the long term. The goal is to confirm the device's safety and performance in real-world use.

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
What this could lead to
If successful, this could confirm that the paclitaxel-coated balloon is a safe and effective option for treating blocked heart arteries in everyday medical practice.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. The study is already done enrolling, and long-term outcomes are still being collected.

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

282 people

The number who actually took part.

Started

Jul 2025

Expected to finish

Feb 2029

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

Patients with symptomatic ischemic coronary heart disease due to discrete de novo lesions or restenosis of the coronary arteries as well as arterial or venous bypasses can be included in the study. The vessel diameter must be 2.0 - 4.0 mm.

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: * Consecutive patients intended to be, or treated by Support C DCB as per physicians' decision and according to Instructions for Use (IFU) in the setting of routine clinical care are entered into the registry. Note: 1. In case of major dissection requiring bailout stenting after DCB use the patients will be included in the registry and followed as per study schedule. 2. If major dissection occurred after lesion preparation, but before DCB use and lesion was stented, the patient will not be included in the registry. Exclusion Criteria: * Patients are excluded if ANY of the following additional conditions apply: * High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * Currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned * A life expectancy of \<1year * Explicit refusal of participation in the registry

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder coronary artery disorder Coronary Disease heart disorder myocardial ischemia

As listed by the trial registrant

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

Coronary arteriosclerosis

Contacts and locations

Locations

  • Evangelisches Krankenhaus Hagen-Haspe gGmbH

    Hagen, 58135, Germany

  • Hospital Universitario Lucus Augusti

    Lugo, 27003, Spain

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, 30120, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital Universitario de La Princesa

    Madrid, 28006, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08026, Spain

  • Katholischen Krankenhaus "St. Johann Nepomuk"

    Erfurt, 99097, Germany

  • Krajska nemocnice Liberec

    Liberec, 46001, Czechia

  • Martha Maria Nürnberg

    Nuremberg, 90491, Germany

  • MediClin Herzzentrum Lahr

    Lahr, 77933, Germany

  • Motol University Hospital

    Prague, 15006, Czechia

  • National Heart Institute (Institut Jantung Negara)

    Kuala Lumpur, 50400, Malaysia

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