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Heart procedure timing trial aims to reduce complications

NCT ID NCT04310046

Disease control Sponsor: University of Zurich 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial studies nearly 1,000 people with severe aortic stenosis and blocked coronary arteries who need both a valve replacement (TAVI) and artery stenting (PCI). Researchers want to see if doing the stenting before or after the valve replacement leads to fewer deaths, heart attacks, or other serious events. The goal is to find the safest timing for these two procedures.

What this could mean

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

Active substance
Procedure: PCI (stenting) and TAVI (valve replacement)
What this could lead to
If it works, this could help doctors choose the best order for these two heart procedures to reduce complications and improve outcomes.
What could go wrong
This is a large trial but still observational in timing; results may not apply to all patients or centers. Both procedures carry risks like bleeding or heart attack.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 986 people

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

Started

Sep 2020

Expected to finish

Jul 2031

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.

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: 1. Patients ≥18 years with severe aortic stenosis and concomitant coronary artery disease accepted for transfemoral TAVI with an Edwards SAPIEN Transcatheter Heart Valve™ and PCI by a multidisciplinary Heart Team. 2. Severe aortic stenosis defined as aortic valve area (AVA) ≤1.0 cm2 and/or mean pressure gradient ≥40 mmHg (echocardiography) and at least one of the following criteria: 1. Dyspnea 2. Angina symptoms 3. Syncope 4. Decline in left ventricular ejection fraction \<50%, symptoms or fall in blood pressure on exercise testing, or presence of high-risk criteria (peak transaortic velocity \>5.5 m/s, severe valve calcification, peak transaortic velocity progression ≥0.3 m/s per year, or severe pulmonary hypertension with systolic pulmonary artery pressure \>60 mmHg) according to current guidelines. 3. At least one coronary artery lesion with ≥70% diameter stenosis on coronary angiogram (by visual estimation) in a coronary artery ≥2.5 mm in diameter and Thrombolysis in Myocardial Infarction (TIMI) flow grade III, deemed amenable to PCI within 45 days before or after TAVI. Hemodynamic lesion assessment by fractional flow reserve (FFR), instantaneous wave-free ratio (iwFR), or comparable indices as well as intravascular imaging-guided PCI are left at the discretion of the operator. 4. Written informed consent. Exclusion Criteria: 1. TAVI by transapical, subclavian, or transaortic access 2. Admission with acute myocardial infarction within 30 days before randomization 3. Elective coronary revascularization within 3 months before randomization 4. Previous coronary artery bypass grafting (CABG) 5. Syntax Score I ≥33 6. Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral anticoagulation 7. Planned open heart surgery 8. Known pregnancy at the time of inclusion 9. Life expectancy \<1 year due to other severe non-cardiac disease 10. Participation in another clinical study with an investigational product 11. Acute COVID-19 infection 12. Patient with previously treated aortic stenosis

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Arterial Occlusive Diseases arteriosclerosis disorder cardiovascular disorder coronary artery disorder heart disorder myocardial ischemia vascular disorder

As listed by the trial registrant

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

Aortic stenosis Coronary artery disease PCI TAVI

Contacts and locations

Locations

  • Academic Teaching Hospital of the Friedrich-Alexander-University Erlangen-Nuremberg

    Fürth, Germany

  • Arnault Tzanck Institute Saint Laurent du Var

    Nice, France

  • Azienda Santa Croce e Carle

    Cuneo, Italy

  • Campus Kerckhoff of the Justus Liebig University Giessen

    Bad Nauheim, Germany

  • Cardiology Department Azienda Ospedaliera Ordine Mauriziano di Torino

    Turin, Italy

  • Cardiology Department, CHU Timone Marseille

    Marseille, France

  • Cardiovascular Center Bad Neustadt/Saale

    Bad Neustadt an der Saale, Germany

  • Geneva University Hospitals

    Geneva, Switzerland

  • German Heart Center of Charité

    Berlin, Germany

  • Heart Center Leipzig at University of Leipzig

    Leipzig, Germany

  • Heart and Vascular Centre Bad Bevensen

    Bad Bevensen, Germany

  • Heinrich-Heine University

    Düsseldorf, Germany

  • Helios Hospital Erfurt

    Erfurt, Germany

  • Helios Hospital Pforzheim

    Pforzheim, Germany

  • Herzzentrum Dresden

    Dresden, Germany

  • IRCCS Azienda Ospedaliera Metropolitana

    Genova, Italy

  • Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

    Palermo, Italy

  • Justus-Liebig University of Giessen

    Giessen, Germany

  • Klinikum Fulda

    Fulda, Germany

  • Klinikum Ingolstadt

    Ingolstadt, Germany

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, Austria

  • Krankenhaus der Barmherzigen Brüder

    Trier, Germany

  • LMU Munich

    Munich, Germany

  • Lausanne University Hospital

    Lausanne, Switzerland

  • Leiden University Medical Center

    Leiden, Netherlands

  • Municipial Hospital Karlsruhe

    Karlsruhe, Germany

  • Otto-von-Guericke University Magdeburg

    Magdeburg, Germany

  • Prosper Hospital

    Recklinghausen, Germany

  • Schüchtermann-Clinic Bad Rothenfelde

    Bad Rothenfelde, Germany

  • Segeberger Kliniken GmbH

    Bad Segeberg, Germany

  • TUM University Hospital

    Munich, Germany

  • The Clinique de l'Infirmerie Protestante

    Lyon, France

  • Thoraxcenter, Erasmus MC

    Rotterdam, Netherlands

  • Toulouse University Hospital

    Toulouse, France

  • Ulm University Heart Center

    Ulm, Germany

  • University Heart and Vascular Centre Hamburg

    Hamburg, Germany

  • University Hospital Basel

    Basel, Switzerland

  • University Hospital Bergmannsheil

    Bochum, Germany

  • University Hospital Dijon

    Dijon, France

  • University Hospital Erlangen

    Erlangen, Germany

  • University Hospital Jena

    Jena, Germany

  • University Hospital Regensburg

    Regensburg, Germany

  • University Hospital Schleswig-Holstein

    Kiel, Germany

  • University Hospital Zürich, Cardiology Department

    Zurich, 8091, Switzerland

  • University of Oldenburg

    Oldenburg, Germany

  • Universitäts-Herzzentrum Freiburg Bad Krozingen, Freiburg & Bad Krozingen

    Bad Krozingen, Germany

  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

  • Zentralklinik Bad Berka

    Bad Berka, Germany

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