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New stent aims to cut bleeding risk for heart patients on blood thinners

NCT ID NCT06863155

Disease control Sponsor: Fundación EPIC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests a new type of stent (a small mesh tube) for people with heart disease who also take blood thinners. These patients have a high risk of bleeding when they also need anti-clotting drugs after stent placement. The new stent is designed to allow a shorter course of anti-clotting medication, which may lower bleeding risk. The study will enroll 500 participants to see if this approach is safe and effective.

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.

Started

May 2025

Expected to finish

Mar 2029

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 under chronic oral anticoagulation undergoing PCI with implantation of a SupraFlex Cruz(r) stent

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: Patients must meet all inclusion criteria: * Patients with Signed informed consent and * Patients with \>=18 years old and * Patients with chronically receiving oral anticoagulation treatment with any type of anticoagulant for any reason and * Patients with de novo Coronary artery disease requiring both elective or urgent percutaneous revascularization due to stable coronary artery disease or acute coronary syndrome with or without ST-segment elevation, and in which an ultrathin strut Sirolimus-eluting stent with bioabsorbable polymer has been used Exclusion Criteria: Patients do not have to meet any exclusion criteria * Patients treated percutaneously with any type of stent other than the SupraFlex Cruz® in the 6 months prior to the index procedure in which he or she is included. * Use in the same procedure or in a scheduled procedure of other stents different from the one evaluated for the treatment of another vessel(s). * Patients treatment for restenosis or stent thrombosis. * Patients presentation in cardiogenic shock or after cardiorespiratory arrest. * Patients with allergy to any of the components of the stent to be used. * Patients with impossibility for follow-up. * Patients with life expectancy less than 1 year.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder myocardial ischemia

As listed by the trial registrant

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

Coronary artery disease Ischemic heart disease

How to take part

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

  1. The places running it

    13 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

  • H.G.U. de Ciudad Real.

    RECRUITING

    Ciudad Real, 13005, Spain

  • Hospital Clinico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Doctor Jose Molina Orosa

    RECRUITING

    Las Palmas de Gran Canaria, 35500, Spain

  • Hospital General Universitari d'Elx

    RECRUITING

    Elche, 03203, Spain

  • Hospital General Universitari de Castelló

    RECRUITING

    Castelló, 12004, Spain

  • Hospital General Universitario de Albacete

    RECRUITING

    Albacete, 02008, Spain

  • Hospital General Universitario de Merida

    RECRUITING

    Badajoz, 6800, Spain

  • Hospital General de Fuerteventura

    RECRUITING

    Puerto del Rosario, 35600, Spain

  • Hospital Universitari de Bellvitge

    RECRUITING

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital Universitario Puerta de Hierro

    RECRUITING

    Majadahonda, 28222, Spain

  • Hospital Universitario San Juan de Alicante

    RECRUITING

    Alicante, 03550, Spain

  • Hospital Universitario de Canarias

    RECRUITING

    Laguna, 38320, Spain

  • Hospital Universitario de Navarra

    RECRUITING

    Pamplona, 31008, Spain

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