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Heart artery balloon study seeks Long-Term answers

NCT ID NCT06915597

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looking at how well drug-coated balloons work for treating narrowed heart arteries. Researchers will follow 1,500 adults who get this treatment to see how they do in the short and long term. The goal is to gather more information on the success and safety of this approach in different situations.

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 1,500 people

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

Started

May 2025

Expected to finish

May 2026

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

The study population will consist of adult patients (≥18 years) with coronary artery disease who undergo percutaneous coronary intervention (PCI) in routine clinical practice in participating centers and are treated with a drug-coated balloon (DCB) for at least one target coronary lesion. The registry will include patients across a broad spectrum of clinical presentations, including stable coronary artery disease and acute coronary syndromes, and will encompass a wide range of lesion subsets such as de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions. Both prospectively and retrospectively enrolled patients will be included, reflecting real-world practice without additional diagnostic or therapeutic interventions beyond standard of care. The population will therefore represent an unselected, all-comer cohort treated with contemporary DCB-based strategies, allowing comprehensive evaluation of clinical and procedural outcomes.

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: Age ≥18 years. Patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) in whom a drug-coated balloon (DCB) is used as the intended treatment strategy for at least one target lesion. DCB use in any clinical presentation, including stable coronary artery disease and acute coronary syndromes. DCB treatment for different lesion subsets, including de novo lesions, in-stent restenosis, bifurcation lesions, small and large vessels, and chronic total occlusions. Successful lesion preparation allowing DCB angioplasty (residual stenosis ≤30% and absence of flow-limiting dissection before DCB inflation, according to operator judgment). Availability of baseline clinical, angiographic, and procedural data. Ability to provide informed consent for prospective enrollment or availability of data according to local regulations for retrospective inclusion. Planned clinical follow-up. Exclusion Criteria: Primary treatment strategy without the use of a drug-coated balloon (e.g., exclusive drug-eluting stent implantation without DCB). Cardiogenic shock at the time of index procedure. Life expectancy less than 1 year due to non-cardiac comorbidities. Contraindication to antiplatelet therapy. Known severe allergy to contrast media not amenable to premedication. Pregnancy. Inability to comply with clinical follow-up. Participation in another interventional clinical trial that could confound outcome assessment.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Bahcelievler Memorial Hospital

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • Bezmialem Vakıf Universitesi

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • Goztepe Medicalpark Hastanesi

    RECRUITING

    Istanbul, Turkey (Türkiye)

  • Kutahya City Hospital

    RECRUITING

    Kütahya, Turkey (Türkiye)

  • Pamukkale University

    RECRUITING

    Denizli, Turkey (Türkiye)

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