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Stent-Free strategy shows promise for Rock-Hard heart arteries

NCT ID NCT07515703

Disease control Sponsor: University of Rome Tor Vergata 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a two-step procedure for people with severely hardened heart arteries. First, doctors used a special device to shave away hard plaque, then inflated a drug-coated balloon to open the artery. The goal was to see if this approach could safely improve blood flow and reduce future heart problems without leaving a permanent stent. The study involved 134 adults with stable or unstable heart disease.

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

134 people

The number who actually took part.

Started

Mar 2019

Finished

Mar 2026

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

all patients with severe calcific coronary lesions treated with plaque modification and solo DCB PCI

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: * Inclusion criteria comprised patients aged ≥18 years with stable or unstable coronary artery disease (chronic coronary syndrome \[CCS\] or acute coronary syndrome \[ACS\]) eligible for percutaneous coronary intervention (PCI). Exclusion Criteria: * Angiographic exclusion criteria included in-stent restenosis (ISR), lesions treated with a hybrid approach (DCB plus drug-eluting stent \[DES\]), residual stenosis \>30%, or ≥ type C dissection after lesion preparation. Clinical exclusion criteria were hemodynamic instability and life expectancy \<1 year.

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Conditions

The condition(s) this trial relates to.

Color Vision Defects coronary artery disorder

As listed by the trial registrant

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

Coronary calcific lesions Drug coated balloon Plaque modification technique

Contacts and locations

Locations

  • Daniela Benedetto

    Rome, Rome, 00133, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.