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Active Not RecruitingNANCT03058627

Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

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 a...

Lead sponsor: Thomas Engstrom•12 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Thomas Engstrom

Collaborators

Rigshospitalet, Denmark
Aarhus University Hospital
Aalborg University Hospital
Odense University Hospital
Lund University Hospital
Karolinska University Hospital
Haukeland University Hospital
Helsinki University Central Hospital
Tampere University Hospital
Oulu University Hospital
Turku University Hospital
Sahlgrenska University Hospital
Pauls Stradins Clinical University Hospital

Age

18 - No limit years

Sex

ALL

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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 19, 2023Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhaseNA

Enrollment454

Start dateSep 2017

Last updatedDec 19, 2023

Condition

Coronary Artery Disease Aortic Valve Stenosis TAVI PCI

Locations shown

Aalborg University Hospital

Aalborg

Department of Cardiology, Skejby University Hospital

Aarhus

Rigshospitalet, Copenhagen University Hospital

Copenhagen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2023Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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