The aim of this study is to evaluate the effect of routine FFR-guided complete revascularization with PCI compared to conservative management in patients with concomitant coronary artery disease who are undergoing TAVI.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years
2. Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team
3. At least one stenosis with FFR ≤ 0.80 or diameter stenosis \> 90% in a coronary artery ≥ 2.5 mm in diameter
Exclusion Criteria:
1. Life expectancy \< 1 year due to other severe non-cardiac disease
2. Severe renal failure with estimated glomerular filtration rate \< 20 ml/min
3. No PCI-eligible coronary artery stenosis, but rotablation is allowed
4. Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days
5. Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx))
6. Only stenoses with thrombolysis in myocardial infarction grad \< 3
7. Potential pregnancy
8. Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium
9. More than one chronic total occlusion (CTO)
Primary outcome measure(s)
All-cause mortality, myocardial infarction, or urgent revascularization — Until the last included patients have been followed for 1 year after the TAVI Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI
Trial sites (12)
Facility
City
Region
Status
Aalborg University Hospital
Aalborg
Denmark
Department of Cardiology, Skejby University Hospital
Aarhus
Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen
Denmark
Department of Cardiology, Odense University Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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