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Dissolving heart scaffolds put to the test in massive Real-World study

NCT ID NCT03327961

Disease control Sponsor: University Hospital of Ferrara 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing absorbable scaffolds—temporary tubes that support blocked heart arteries and then dissolve over time—in over 1,100 people with coronary artery disease. Researchers are tracking heart-related deaths, heart attacks, and the need for repeat procedures to see how safe and effective these scaffolds are in everyday medical practice. Participants must be over 18, have at least one scaffold implanted, and agree to follow-up for at least one year.

What this could mean

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

Active substance
absorbable scaffold (e.g., Magmaris, Desolve)
What this could lead to
If successful, this could show that absorbable scaffolds are a safe and effective option for treating blocked arteries, potentially reducing the need for permanent metal stents.
What could go wrong
This is an observational study, not a randomized trial, so results may not prove superiority over standard stents. Risks include blood clots, vessel re-narrowing, and the need for long-term anti-clotting medication.

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 1,111 people

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

Started

Dec 2017

Expected to finish

Dec 2034

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

Patients with symptomatic coronary artery disease needing the treatment of de novo native coronary artery lesions.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * subjects \>18 years * sign of the patients informed consent * implanation of at least one scaffold Exclusion Criteria: * inability to garantuee at least one year follow-up * inabiliuty to garantuee at least one year compliance to dual antiplatelet regimen

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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

    17 sites. 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

  • AO San Giovanni di Dio

    RECRUITING

    Agrigento, Agrigento, Italy

  • AOU San Luigi Gonzaga

    RECRUITING

    Orbassano, Torino, Italy

  • Azienda Ospedaliera Universitaria di Bologna

    RECRUITING

    Bologna, Bologna, Italy

  • Maria Cecilia Hospital - GVM Care & Research

    RECRUITING

    Cotignola, Ravenna, Italy

  • Ospedale Caravaggio-Treviglio

    RECRUITING

    Treviglio, Bergamo, Italy

  • Ospedale Guglielmo da Saliceto

    RECRUITING

    Piacenza, Piacenza, Italy

  • Ospedale SS Annunziata

    RECRUITING

    Savigliano, Cuneo, Italy

  • Ospedale di Rivoli

    RECRUITING

    Rivoli, Torino, Italy

  • Ospedale di Sanremo

    RECRUITING

    Sanremo, Italy

  • U.O. Cardiologia, Azienda Ospedaliera Universitaria di Modena, Policlinico

    RECRUITING

    Modena, Modena, Italy

  • U.O. Cardiologia, Ospedale Maggiore

    RECRUITING

    Bologna, Bologna, Italy

  • U.O. Cardiologia, Ospedale Morgagni Pierantoni

    RECRUITING

    Forlì, Forlì-Cesena, Italy

  • U.O. Cardiologia, Ospedale di Baggiovara

    RECRUITING

    Modena, Modena, Italy

  • U.O. di Cardiologia, Azienda Ospedaliero-Universitaria di Parma

    RECRUITING

    Parma, Parma, Italy

  • U.O. di Cardiologia, Ospedale Santa Maria delle Croci

    RECRUITING

    Ravenna, Ravenna, Italy

  • U.O. di Cardiologia, Ospedale degli Infermi

    RECRUITING

    Rimini, Rimini, Italy

  • University Hospital of Ferrara

    RECRUITING

    Cona, Ferrara, 44124, Italy

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