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New heart stent tool could simplify procedures for millions

NCT ID NCT05437900

Disease control Sponsor: CoreAalst BV 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a new pressure microcatheter works as well as the standard pressure wire for guiding stent placement in people with coronary artery disease. About 2,500 participants will be randomly assigned to one of the two devices during their procedure. The main goal is to see if the microcatheter leads to similar rates of major heart problems like death, heart attack, or repeat procedures over 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
Pressure microcatheter (a thin tube used during heart stent placement to measure blood flow)
What this could lead to
If it works, this could show that the pressure microcatheter is just as good as the standard wire for guiding stent placement, potentially offering doctors a simpler tool.
What could go wrong
This is a large phase 4 trial, but it's testing non-inferiority (not superiority), so the new device may not be better. Risks include typical heart procedure complications like bleeding or vessel damage.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 2,500 people

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

Started

Sep 2022

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

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: 1. The subject must be at least 18 years of age and younger than 85 years old. 2. Eligible for elective PCI. 3. Stable angina or ACS (non-culprit vessels only and outside of primary intervention during acute STEMI) 4. Subject willing to participate and able to understand, read and sign the Informed Consent. Exclusion Criteria: 1. STEMI as clinical presentation. 2. Chronic total occlusion as a target vessel. 3. Significant contraindication to adenosine administration (e.g. heart block, severe asthma) 4. Uncontrolled or recurrent ventricular tachycardia. 5. Hemodynamic instability. 6. Severe valvular disease. 7. Severe renal dysfunction defined as an eGFR ≤30 mL/min/1.73 m2. 8. Comorbidity with life expectancy ≤ 2 years. 9. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 months in the patient presenting with an ACS, or at least six months in the patient presenting with stable CAD, unless the patient is also taking chronic oral anticoagulation in which case a shorter duration of DAPT may be prescribed per local standard of care. 10. Planned major cardiac or non-cardiac surgery within 24 months after the index procedure. Note: major surgery is any invasive procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded. 11. Subject has known hypersensitivity or contraindication to any of the study drugs (including all P2Y12 inhibitors, one or more components of the study devices, including everolimus, zotarolimus, biolimus, sirolimus, cobalt, chromium, nickel, platinum, tungsten, acrylic, and fluoropolymers, or radiocontrast dye that cannot be adequately pre- medicated. 12. The subject has received a functioning solid organ transplant or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months. 13. The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy. 14. The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum. 15. Subject has a platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3. 16. The subject has a documented or suspected hepatic disorder defined as cirrhosis or Child-Pugh ≥ Class B. 17. The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, any prior intracranial bleed, any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy of \<2 years for any non-cardiac cause. 18. The subject is currently participating in another investigational drug or device clinical study. 19. Pregnancy or nursing. 20. Presence of other anatomic or comorbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements or impact the scientific soundness of the clinical investigation results.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder

As listed by the trial registrant

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

Acute coronary syndrome 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

    24 sites in 7 countries. 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

  • Amsterdam UMC

    RECRUITING

    Amsterdam, Netherlands

  • Azienda Ospedaliera Universitaria Federico II

    RECRUITING

    Naples, Italy

  • Azienda Ospedaliera Universitaria Sant'Andrea

    RECRUITING

    Rome, Italy

  • CHU Lille

    RECRUITING

    Lille, France

  • Catharina Ziekenhuis

    RECRUITING

    Eindhoven, Netherlands

  • Catholic Medical Center Koblenz-Montabaur

    ACTIVE_NOT_RECRUITING

    Koblenz, Germany

  • Claude Bernard University

    ACTIVE_NOT_RECRUITING

    Lyon, France

  • Dr. Jurasz University Hospital No. 1

    RECRUITING

    Bydgoszcz, Poland

  • Germans Trias i Pujol Hopital

    RECRUITING

    Barcelona, Spain

  • Herzzentrum Dresden

    RECRUITING

    Dresden, Germany

  • Herzzentrum Lahr

    RECRUITING

    Lahr, Germany

  • Hospital Clínic Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital de Belvitge

    RECRUITING

    Barcelona, Spain

  • ICPS

    RECRUITING

    Paris, France

  • John Paul II Specialistic Hospital

    RECRUITING

    Krakow, Poland

  • Klinikum Fürth

    RECRUITING

    Fürth, Germany

  • Klinikum Herford

    RECRUITING

    Herford, Germany

  • National Cardiac Institute

    RECRUITING

    Warsaw, Poland

  • Nuovo Arcispedale S.Anna Di Ferrara

    RECRUITING

    Ferrara, Italy

  • OLV Aalst

    RECRUITING

    Aalst, Oost-Vlaanderen, 9300, Belgium

  • Ospedale Civile Sant'Andrea

    RECRUITING

    La Spezia, Italy

  • Ospedale Santa Maria Goretti

    RECRUITING

    Latina, Italy

  • QILU Hospital of Shandong University

    ACTIVE_NOT_RECRUITING

    Shandong, China

  • UMCN Radboud

    RECRUITING

    Nijmegen, Netherlands

  • Universitair ziekenhuis Brussel

    RECRUITING

    Brussels, Belgium

  • Universitätsklinik

    RECRUITING

    Mainz, Germany

  • West China Hospital of Sichuan University

    ACTIVE_NOT_RECRUITING

    Sichuan, China

  • ZOL

    RECRUITING

    Genk, Belgium

  • Zhongshan Hospital of Fudan University

    ACTIVE_NOT_RECRUITING

    Shanghai, Xuhui District, 200031, China

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