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New balloon technique aims to keep heart arteries open longer

NCT ID NCT07391033

Disease control Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways of preparing a re-narrowed heart artery before using a drug-coated balloon to open it. In 500 adults with in-stent restenosis, half will get standard balloon prep and half will get a more aggressive prep with special cutting or scoring balloons. The goal is to see if the aggressive approach reduces heart attacks, cardiac death, or the need for another procedure.

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 (DCB) angioplasty with cutting/scoring/OPN balloons
What this could lead to
If it works, this could point toward a better way to treat re-narrowed arteries after stenting, reducing the need for repeat procedures.
What could go wrong
This is a relatively early-stage comparison study; the aggressive balloon approach may not prove safer or more effective than standard preparation, and there are risks of vessel injury or complications.

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 500 people

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

Expected to start

Jun 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.

Who is studied

Adult patients who underwent drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR) at participating centers.

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: * Adult patients ≥18 years of age * Patients who underwent DCB angioplasty for in-stent restenosis Exclusion Criteria: \- Lack of clinical outcome assessment

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary restenosis

As listed by the trial registrant

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

Coronary artery disease In-stent coronary artery restenosis

How to take part

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

  1. 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 ↗

  2. 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.

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