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Can a Drug-Coated balloon keep heart arteries open without a stent?

NCT ID NCT07817719

Disease control Sponsor: University of Sao Paulo General Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether a drug-coated balloon alone can keep heart arteries open after clearing a chronic total blockage, without leaving a permanent metal stent. The study plans to enroll 38 adults with a long-standing coronary occlusion and angina or documented ischemia. Doctors deliver paclitaxel to the artery wall using a balloon, then track how well the vessel stays open at nine months with angiography and ultrasound imaging.

What this could mean

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

Active substance
a paclitaxel-coated balloon catheter
What this could lead to
If it works, this could offer a stent-free option for reopening long-blocked heart arteries, leaving no metal implant behind.
What could go wrong
This is a small, single-center pilot with no comparison group, so it cannot prove the approach beats stents. The artery may renarrow, and the trial is not designed to show clinical superiority.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 38 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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.

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 or older * Chronic total coronary occlusion (CTO) of more than three months' duration, confirmed by prior angiography or lesion characteristics * Clinical indication for revascularization, defined as limiting angina and/or documented ischemia * Successful CTO recanalization, defined as restoration of Thrombolysis in Myocardial Infarction (TIMI) grade 3 antegrade flow and absence of any flow-limiting dissection * Life expectancy greater than one year * Written informed consent provided Exclusion Criteria: * Acute coronary syndrome or cardiogenic shock at presentation * Flow-limiting dissection (TIMI grade below 3) requiring stent implantation * Left main coronary artery as the CTO target vessel * Reference vessel diameter below 2.0 mm or above 4.0 mm * In-stent chronic total occlusion * Absolute contraindication to dual antiplatelet therapy for the protocol-defined duration of 3 to 6 months * Inability to achieve adequate lesion preparation, defined as absence of flow-limiting or otherwise significant dissection and satisfactory conditions for drug delivery, confirmed by angiography and intravascular ultrasound (IVUS)

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Conditions

The condition(s) this trial relates to.

Angina, Stable coronary artery disorder Coronary Occlusion intermediate coronary syndrome Vascular Remodeling

As listed by the trial registrant

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

Angina (stable) Chronic total occlusion Coronary artery disease Coronary occlusion

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

  • InCor - Instituto do Coracao - University of Sao Paulo Heart Institute

    São Paulo, São Paulo, 05403-000, Brazil

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