New balloon technique aims to keep heart arteries open longer

NCT ID NCT07391033

Not yet recruiting Disease control Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS Source: ClinicalTrials.gov ↗

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.

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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

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