Aortic StenosisTAVI-PCINCT04310046
Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
A study testing PCI before TAVI and PCI after TAVI in people with Aortic Stenosis and Coronary Artery Disease, run by University of Zurich at 48 sites in 6 countries.
Trial summary
The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the safety and efficacy of angiography-guided… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Coronary Artery Disease, TAVI
- What is being tested?
- PCI before TAVI and PCI after TAVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 986 participants
- Where
- 48 sitesin 6 countries
- Study dates
- 30 Sep 2020to Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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:
- Dyspnea
- Angina symptoms
- Syncope
- 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.
- 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.
- Written informed consent.
Who cannot join
- TAVI by transapical, subclavian, or transaortic access
- Admission with acute myocardial infarction within 30 days before randomization
- Elective coronary revascularization within 3 months before randomization
- Previous coronary artery bypass grafting (CABG)
- Syntax Score I ≥33
- Any contraindications for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor (clopidogrel, ticagrelor or prasugrel), except for patients on oral anticoagulation
Show all 12Show fewer
- Planned open heart surgery
- Known pregnancy at the time of inclusion
- Life expectancy <1 year due to other severe non-cardiac disease
- Participation in another clinical study with an investigational product
- Acute COVID-19 infection
- Patient with previously treated aortic stenosis
Trial locations and contacts
48 sites in 6 countries.
48 sites in 6 countries
Germany32 sites
Zentralklinik Bad Berka
Bad Berka
Heart and Vascular Centre Bad Bevensen
Bad Bevensen
Universitäts-Herzzentrum Freiburg Bad Krozingen, Freiburg & Bad Krozingen
Bad Krozingen
Campus Kerckhoff of the Justus Liebig University Giessen
Bad Nauheim
Cardiovascular Center Bad Neustadt/Saale
Bad Neustadt an der Saale
Schüchtermann-Clinic Bad Rothenfelde
Bad Rothenfelde
Segeberger Kliniken GmbH
Bad Segeberg
German Heart Center of Charité
Berlin
University Hospital Bergmannsheil
Bochum
Herzzentrum Dresden
Dresden
Heinrich-Heine University
Düsseldorf
Helios Hospital Erfurt
Erfurt
University Hospital Erlangen
Erlangen
Universitätsklinikum Frankfurt
Frankfurt
Klinikum Fulda
Fulda
Academic Teaching Hospital of the Friedrich-Alexander-University Erlangen-Nuremberg
Fürth
Justus-Liebig University of Giessen
Giessen
University Heart and Vascular Centre Hamburg
Hamburg
Klinikum Ingolstadt
Ingolstadt
University Hospital Jena
Jena
Municipial Hospital Karlsruhe
Karlsruhe
University Hospital Schleswig-Holstein
Kiel
Heart Center Leipzig at University of Leipzig
Leipzig
Otto-von-Guericke University Magdeburg
Magdeburg
LMU Munich
Munich
TUM University Hospital
Munich
University of Oldenburg
Oldenburg
Helios Hospital Pforzheim
Pforzheim
Prosper Hospital
Recklinghausen
University Hospital Regensburg
Regensburg
Krankenhaus der Barmherzigen Brüder
Trier
Ulm University Heart Center
Ulm
France5 sites
University Hospital Dijon
Dijon
The Clinique de l'Infirmerie Protestante
Lyon
Cardiology Department, CHU Timone Marseille
Marseille
Arnault Tzanck Institute Saint Laurent du Var
Nice
Toulouse University Hospital
Toulouse
Italy4 sites
Azienda Santa Croce e Carle
Cuneo
IRCCS Azienda Ospedaliera Metropolitana
Genova
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
Palermo
Cardiology Department Azienda Ospedaliera Ordine Mauriziano di Torino
Turin
Switzerland4 sites
University Hospital Basel
Basel
Geneva University Hospitals
Geneva
Lausanne University Hospital
Lausanne
University Hospital Zürich, Cardiology Department
Zurich, 8091
Netherlands2 sites
Leiden University Medical Center
Leiden
Thoraxcenter, Erasmus MC
Rotterdam
About this study
The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the safety and efficacy of angiography-guided complete revascularization performed after (within 1-45 days) with angiography-guided complete revascularization performed before (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.
Read the detailed description
The prevalence of coronary artery disease in patients with severe aortic stenosis is high. About 30-60% of patients undergoing TAVI exhibit coexisting coronary artery disease. Optimal timing of coronary revascularization in patients with severe aortic stenosis and concomitant coronary artery disease undergoing TAVI is uncertain.
The goal of this investigator-initiated, randomized, multicenter, two-arm, open-label, non-inferiority trial is to compare two treatment strategies that are currently performed in clinical practice: PCI before TAVI versus PCI after TAVI in patients with severe aortic stenosis and concomitant coronary artery disease.
In this trial, patients with severe aortic stenosis and concomitant coronary artery disease accepted for TAVI and PCI by the Heart Team will be randomized in a 1:1 ratio to the following strategies: angiography-guided complete coronary revascularization before (within 1-45 days) or after (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.
For both treatment groups, coronary artery lesions with ≥70% diameter stenosis on coronary angiogram (by visual estimation) in a coronary artery ≥2.5 mm in diameter are considered significant.
TAVI and PCI will be performed according to current guidelines.
- Conditions
- Aortic Stenosis, Coronary Artery Disease, TAVI, PCI
- Being tested
- PCI before TAVI, PCI after TAVI
- Keywords
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, Percutaneous Coronary Intervention, Heart Diseases, Valvular Disease, Coronary Artery Disease, Myocardial Ischemia, Cardiovascular Diseases, Vascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases
- Medical subject headings
- Aortic Valve Stenosis, Coronary Artery Disease, Heart Diseases, Myocardial Ischemia, Cardiovascular Diseases, Vascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI before TAVIProcedure or surgery
TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with ≥70% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter.
PCI after TAVIProcedure or surgery
TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with ≥70% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter.
| Study group | Role | What they receive |
|---|---|---|
| PCI before TAVI | Other | PCI is performed within 1-45 days before TAVI. Receives: Procedure: PCI before TAVI |
| PCI after TAVI | Experimental | PCI is performed within 1-45 days after TAVI. Receives: Procedure: PCI after TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is the number of participants experiencing the primary outcome measure
The primary outcome measure is a composite of:
- All-cause death
- Non-fatal myocardial infarction
- Ischemia-driven revascularization
- Rehospitalization (valve- or procedure-related including heart failure)
- Life-threatening/disabling or major bleeding (according to VARC-2)
Measured: 1 year
Secondary outcomes (15)
The primary outcome measure
Measured: Discharge (hospitalization first and second procedure), 3 months, 2 years and 5 years
Single components of the primary endpoint
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
All cause death and myocardial infarction
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Cardiovascular death and myocardial infarction
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
All cause death, myocardial infarction and ischemia-driven revascularization
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
All cause death, myocardial infarction, ischemia-driven revascularization and rehospitalization
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Cardiovascular death
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Stroke
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Peri-procedural myocardial infarction (PCI)
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Peri-procedural myocardial infarction (TAVI)
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Major vascular complications
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Bleeding events
Bleeding events are defined according to the Bleeding Academic Research Consortium (BARC) definition
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Symptom status and change from baseline in symptom status (Canadian Cardiovascular Society (CCS) and New York Hear Association (NYHA) classification)
Measured: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Quality of life (as assessed by the KCCQ and TASQ questionnaires)
Kansas City Cardiomyopathy questionnaire (KCCQ) and the Toronto Aortic Stenosis Quality of Life questionnaire (TASQ)
Measured: Admission (for second procedure), 3 months, 1 year, 2 years and 5 years
Change from baseline in Quality of life (as assessed by the KCCQ and TASQ questionnaires)
Kansas City Cardiomyopathy questionnaire (KCCQ) and the Toronto Aortic Stenosis Quality of Life questionnaire (TASQ)
Measured: Admission (for second procedure), 3 months, 1 year, 2 years and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start30 Sep 2020
- Primary completionJul 2026 (estimated)
- Study completionJul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 986 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Kasel, MD, Principal investigator, University Hospital, ZürichBarbara E. Stähli, MD, eMBA, Principal investigator, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310046
- Sponsor's protocol ID
- TAVI PCI
- Acronym
- TAVI-PCI
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2020
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stahli BE, Linke A, Westermann D, Van Mieghem NM, Leistner DM, Massberg S, Alber H, Mugge A, Musumeci G, Kesterke R, Schneider S, Kastrati A, Ford I, Ruschitzka F, Kasel MA; TAVI PCI Investigators. A randomized comparison of the treatment sequence of percutaneous coronary intervention and transcatheter aortic valve implantation: Rationale and design of the TAVI PCI trial. Am Heart J. 2024 Nov;277:104-113. doi: 10.1016/j.ahj.2024.07.019. Epub 2024 Aug 8.
PubMed 39121916Stahli BE, Ruschitzka F, Westermann D, Linke A, Mangner N, Van Mieghem NM, Kesterke R, Oberholzer L, Rothe J, von Zur Muhlen C, Zeus T, Kim WK, Lauten P, Werner N, Burgdorf C, Alber H, Schulze PC, Joner M, Michel J, Candreva A, Jakob P, Wurdinger M, Stehli J, Gotschy A, Templin C, Dzemali O, Gaede L, Massberg S, Lauten A, van der Kley F, Ewers A, Nestelberger T, Abdel-Wahab M, Musumeci G, Barth S, Hansen M, Mugge A, Seiffert M, Leistner DM, Cuisset T, Schneider S, Kastrati A, Ford I, Kasel MA; TAVI PCI Investigators. Timing of PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2026 Aug 30. doi: 10.1056/NEJMoa2606924. Online ahead of print.
PubMed 42670987
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of Transcatheter Aortic Valve Implantation and Percutaneous Coronary Intervention - The TAVI PCI Trial
- ClinicalTrials.gov ID
- NCT04310046
- Acronym / sponsor ID
- TAVI-PCI / TAVI PCI
- Conditions
- Aortic Stenosis, Coronary Artery Disease, TAVI, PCI
- Keywords
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, Percutaneous Coronary Intervention, Heart Diseases, Valvular Disease, Coronary Artery Disease, Myocardial Ischemia, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 986 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the safety and efficacy of angiography-guided complete revascularization performed after (within 1-45 days) with angiography-guided complete revascularization performed before (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.
Detailed description
The prevalence of coronary artery disease in patients with severe aortic stenosis is high. About 30-60% of patients undergoing TAVI exhibit coexisting coronary artery disease. Optimal timing of coronary revascularization in patients with severe aortic stenosis and concomitant coronary artery disease undergoing TAVI is uncertain.
The goal of this investigator-initiated, randomized, multicenter, two-arm, open-label, non-inferiority trial is to compare two treatment strategies that are currently performed in clinical practice: PCI before TAVI versus PCI after TAVI in patients with severe aortic stenosis and concomitant coronary artery disease.
In this trial, patients with severe aortic stenosis and concomitant coronary artery disease accepted for TAVI and PCI by the Heart Team will be randomized in a 1:1 ratio to the following strategies: angiography-guided complete coronary revascularization before (within 1-45 days) or after (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.
For both treatment groups, coronary artery lesions with ≥70% diameter stenosis on coronary angiogram (by visual estimation) in a coronary artery ≥2.5 mm in diameter are considered significant.
TAVI and PCI will be performed according to current guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI before TAVI | Other | Procedure: PCI before TAVIPCI is performed within 1-45 days before TAVI. |
| PCI after TAVI | Experimental | Procedure: PCI after TAVIPCI is performed within 1-45 days after TAVI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- 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:
- 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.
- Written informed consent.
Key exclusion criteria (12 listed)
- TAVI by transapical, subclavian, or transaortic access
- Admission with acute myocardial infarction within 30 days before randomization
- Elective coronary revascularization within 3 months before randomization
- Previous coronary artery bypass grafting (CABG)
- Syntax Score I ≥33
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI before TAVITAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with ≥70% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter. | Procedure or surgery | PCI before TAVI |
| PCI after TAVITAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with ≥70% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter. | Procedure or surgery | PCI after TAVI |
Primary outcome
The primary outcome measure is the number of participants experiencing the primary outcome measure
Time frame: 1 year
The primary outcome measure is a composite of: * All-cause death * Non-fatal myocardial infarction * Ischemia-driven revascularization * Rehospitalization (valve- or procedure-related including heart failure) * Life-threatening/disabling or major bleeding (according to VARC-2)
15 secondary outcomes
The primary outcome measure
Time frame: Discharge (hospitalization first and second procedure), 3 months, 2 years and 5 years
Single components of the primary endpoint
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
All cause death and myocardial infarction
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Cardiovascular death and myocardial infarction
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
All cause death, myocardial infarction and ischemia-driven revascularization
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
All cause death, myocardial infarction, ischemia-driven revascularization and rehospitalization
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Cardiovascular death
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Stroke
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Peri-procedural myocardial infarction (PCI)
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Peri-procedural myocardial infarction (TAVI)
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Major vascular complications
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Bleeding events
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Symptom status and change from baseline in symptom status (Canadian Cardiovascular Society (CCS) and New York Hear Association (NYHA) classification)
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Quality of life (as assessed by the KCCQ and TASQ questionnaires)
Time frame: Admission (for second procedure), 3 months, 1 year, 2 years and 5 years
Change from baseline in Quality of life (as assessed by the KCCQ and TASQ questionnaires)
Time frame: Admission (for second procedure), 3 months, 1 year, 2 years and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Background: PubMed 39121916Stahli BE, Linke A, Westermann D, Van Mieghem NM, Leistner DM, Massberg S, Alber H, Mugge A, Musumeci G, Kesterke R, Schneider S, Kastrati A, Ford I, Ruschitzka F, Kasel MA; TAVI PCI Investigators. A randomized comparison of the treatment sequence of percutaneous coronary intervention and transcatheter aortic valve implantation: Rationale and design of the TAVI PCI trial. Am Heart J. 2024 Nov;277:104-113. doi: 10.1016/j.ahj.2024.07.019. Epub 2024 Aug 8.
- Derived from this study: PubMed 42670987Stahli BE, Ruschitzka F, Westermann D, Linke A, Mangner N, Van Mieghem NM, Kesterke R, Oberholzer L, Rothe J, von Zur Muhlen C, Zeus T, Kim WK, Lauten P, Werner N, Burgdorf C, Alber H, Schulze PC, Joner M, Michel J, Candreva A, Jakob P, Wurdinger M, Stehli J, Gotschy A, Templin C, Dzemali O, Gaede L, Massberg S, Lauten A, van der Kley F, Ewers A, Nestelberger T, Abdel-Wahab M, Musumeci G, Barth S, Hansen M, Mugge A, Seiffert M, Leistner DM, Cuisset T, Schneider S, Kastrati A, Ford I, Kasel MA; TAVI PCI Investigators. Timing of PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2026 Aug 30. doi: 10.1056/NEJMoa2606924. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Kasel, MD principal investigator
University Hospital, Zürich
Barbara E. Stähli, MD, eMBA principal investigator
University Hospital, Zürich
48 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI before TAVI and PCI after TAVI in people with Aortic Stenosis and Coronary Artery Disease, run by University of Zurich at 48 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Germany, France, Italy, Switzerland, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is the number of participants experiencing the primary outcome measure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04310046, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.