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Heart stent SUPRAFLEX CRUZ under Post-Market scrutiny for multivessel disease

NCT ID NCT05617599

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study is tracking 508 patients with multivessel coronary artery disease who received the SUPRAFLEX CRUZ stent during routine care. Researchers are monitoring for heart-related events like heart attacks, repeat procedures, and heart function over 12 months. The goal is to confirm the stent's safety and performance in real-world settings.

What this could mean

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

Active substance
SUPRAFLEX CRUZ stent (a medical device used to open blocked heart arteries)
What this could lead to
If successful, this study could confirm that the SUPRAFLEX CRUZ stent is safe and effective for treating patients with blockages in multiple heart arteries.
What could go wrong
This is an observational post-market study, not a randomized trial, so results may be less definitive. Risks include stent-related complications like blood clots or re-narrowing of arteries.

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 508 people

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

Started

May 2023

Expected to finish

Dec 2026

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 treated with MULTIFLEX PMCF according to routine hospital practice and following instructions for use

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: * ≥ 18 years old and; * Patients treated with SUPRAFLEX CRUZ according to routine hospital practice and following instructions for use * Patients with multivessel coronary artery disease (understood as that which affects more than one territory of the major epicardial coronary arteries - anterior descending, circumflex, right coronary artery) who is treated with more than 1 stent under study in lesions located in more than 1 of the aforementioned arteries. * Substudy: Patients with Ejection Fraction \<45% by Echocardiography * Informed consent signed Exclusion Criteria: * Not meet inclusion criteria * Contraindication for antiplatelet treatment * Patient life expectancy less than 12 months

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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 (CAD) 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

    21 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

  • Hospital Clinico Universitario de Salamanca

    RECRUITING

    Salamanca, 37007, Spain

  • Hospital Clínico Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, 30120, Spain

  • Hospital Clínico Universitario de Santiago de Compostela

    RECRUITING

    Santiago de Compostela, 15706, Spain

  • Hospital General Universitario de Castellón

    RECRUITING

    Castelló, 12004, Spain

  • Hospital General Universitario de Ciudad Real

    RECRUITING

    Ciudad Real, 13005, Spain

  • Hospital General Universitario de Elche

    RECRUITING

    Elche, Alicante, 03203, Spain

  • Hospital Parc Tauli

    RECRUITING

    Sabadell, 08208, Spain

  • Hospital Universitari Arnau de Vilanova

    RECRUITING

    Lleida, 25198, Spain

  • Hospital Universitari Dr. Josep Trueta

    RECRUITING

    Girona, 17007, Spain

  • Hospital Universitari Vall D'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • Hospital Universitario Clínico San Cecilio

    RECRUITING

    Granada, 18016, Spain

  • Hospital Universitario Lozano Blesa

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario San Pedro de Alcántara

    RECRUITING

    Cáceres, 10003, Spain

  • Hospital Universitario Virgen Del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Hospital Universitario Y Politécnico La Fé

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario de Cruces

    RECRUITING

    Barakaldo, 48903, Spain

  • Hospital Universitario de Leon

    RECRUITING

    León, 24001, Spain

  • Hospital Universitario de Toledo

    RECRUITING

    Toledo, 45007, Spain

  • Hospital de La Santa Creu I Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

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