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Can a balloon replace stents in treating clogged heart arteries?

NCT ID NCT07794839

Disease control Sponsor: Istanbul Mehmet Akif Ersoy Educational and Training Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This study looks at whether drug-coated balloons, which deliver medication directly to the artery wall, work as well as drug-eluting stents in people with coronary artery disease. Researchers will track 1,000 patients who received either treatment to compare rates of artery re-blockage, heart attacks, and heart-related death. The goal is to see if balloons can be a safe and effective alternative to permanent metal stents.

What this could mean

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

Active substance
drug-coated balloon
What this could lead to
If drug-coated balloons prove as effective as stents, they could offer a stent-free option for treating coronary artery disease, potentially reducing long-term complications.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by patient differences. The balloons may not match stents in preventing artery re-narrowing or heart events.

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 1,000 people

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

Started

Jan 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

coronary artery lesions treated with drug coated balloon dilatation or drug eluting stent implantation

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- Patients aged 18 years and older; 2- Patients with silent ischemia, chronic coronary syndrome, or ACS; 3- Patients treated with drug-eluting balloon angioplasty. Exclusion criteria: 1- Patients with ST-segment elevation myocardial infarction and/or cardiogenic shock; 2- Patients with graft vessels from CABG surgery; 3- Patients who are contraindicated from dual antiplatelet therapy; 4- Patients with a life expectancy of less than 1 year; 5- Pregnant patients; 6- Patients with active bleeding, hematological disease, or cancer; 7- Patients unable to attend clinical follow-ups; 8- Patients with planned surgery within the next 12 months.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease

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

    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

  • University of Health Sciences, Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Center, Training and Research Hospital, Department of Cardiology

    RECRUITING

    Istanbul, Turkey (Türkiye)

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