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Clinical Trials in Denmark / NCT03058627
Active, not recruiting Not applicable

Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

NCT03058627 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2017-09-15
Last updated
2023-12-19

Condition(s) studied

Coronary Artery DiseaseAortic Valve StenosisTAVIPCI

Investigational drug(s) / intervention(s)

PCI

PCI: FFR guided PCI

Study summary

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)

Trial sites (12)

FacilityCityRegionStatus
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 Odense Denmark
Helsinki University Hospital Helsinki Finland
Oulu University Hospital Oulu Finland
Tampere University Hospital Tampere Finland
Turku University Hospital Turku Finland
Riga University Hospital Riga Latvia
Sahlgrenska Gothenburg Sweden
Lund University Hospital Lund Sweden
Karolinska Stockholm Sweden

More Thomas Engstrom trials in Denmark

Other trials for the same condition

Official registry record

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.

View NCT03058627 on ClinicalTrials.gov ↗ ← All trials in Denmark