An interventional study of PCI before TAVI and PCI after TAVI in Aortic Stenosis, Coronary Artery Disease and TAVI, sponsored by University of Zurich. Active, not recruiting at 48 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by University of Zurich · Not applicable, Interventional, and Treatment
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®.
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.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 986 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →University of Zurich is the lead sponsor of 1,049 studies on the registry; 133 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PCI is performed within 1-45 days before TAVI.
Procedure: PCI before TAVI
PCI is performed within 1-45 days after TAVI.
Procedure: PCI after TAVI
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.
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.
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)
Time frame: 1 year
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
Bleeding events are defined according to the Bleeding Academic Research Consortium (BARC) definition
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)
Kansas City Cardiomyopathy questionnaire (KCCQ) and the Toronto Aortic Stenosis Quality of Life questionnaire (TASQ)
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)
Kansas City Cardiomyopathy questionnaire (KCCQ) and the Toronto Aortic Stenosis Quality of Life questionnaire (TASQ)
Time frame: Admission (for second procedure), 3 months, 1 year, 2 years and 5 years
Procedural success (PCI)
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Device success (TAVI)
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Any revascularization
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Target lesion revascularization
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Target vessel revascularization
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
In-stent thrombosis
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Acute kidney injury
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
New-onset atrial fibrillation
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
New permanent pacemaker implantation
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Aortic valve-related dysfunction requiring repeat procedure
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Amount of contrast medium (PCI)
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Fluoroscopy time (PCI)
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Radiation exposure (dose area product, PCI)
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Conversion to open heart surgery
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Use of catecholamines during PCI
Time frame: Discharge (hospitalization first and second procedure), 3 months, 1 year, 2 years and 5 years
Plan to share: No
Started Sep 2020 (actual). Primary completion is estimated for Jul 2026, 70 months after the start.
Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 70 months is above that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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