Coronary Artery Disease Clinical Trial
— NOTION-3Official title:
Routine Revascularization With Percutaneous Coronary Intervention in Patients With Coronary Artery Disease Undergoing Transcatheter Aortic Valve Implantation - the Nordic Aortic Valve Intervention-3 Trial
Verified date | December 2023 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 454 |
Est. completion date | November 15, 2027 |
Est. primary completion date | January 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | 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 | |
Finland | Helsinki University Hospital | Helsinki | |
Finland | Oulu University Hospital | Oulu | |
Finland | Tampere University Hospital | Tampere | |
Finland | Turku University Hospital | Turku | |
Latvia | Riga University Hospital | Riga | |
Sweden | Sahlgrenska | Gothenburg | |
Sweden | Lund University Hospital | Lund | |
Sweden | Karolinska | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Thomas Engstrom | Aalborg University Hospital, Aarhus University Hospital, Haukeland University Hospital, Helsinki University Central Hospital, Karolinska University Hospital, Lund University Hospital, Odense University Hospital, Oulu University Hospital, Pauls Stradins Clinical University Hospital, Rigshospitalet, Denmark, Sahlgrenska University Hospital, Sweden, Tampere University Hospital, Turku University Hospital |
Denmark, Finland, Latvia, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality, myocardial infarction, or urgent revascularization | Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | All cause mortality | Number of patients experiencing all cause mortality | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Myocardial infarction | Number of patients experiencing myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Urgent revascularization | Number of patients experiencing urgent revascularization | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | All cause mortality or myocardial infarction | Number of patients experiencing all cause mortality or myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Cardiovascular mortality | Number of patients experiencing cardiovascular mortality | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Cardiovascular mortality, myocardial infarction, or urgent PCI | Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Cardiovascular mortality or myocardial infarction | Number of patients experiencing cardiovascular mortality or myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Admission for new onset of heart failure | Number of patients experiencing admission for new onset of heart failure | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Peri-procedural (PCI) myocardial infarction | Number of patients experiencing peri-procedural (PCI) myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Peri-procedural (TAVI) myocardial infarction | Number of patients experiencing peri-procedural (TAVI) myocardial infarction | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Any revascularization | Number of patients experiencing any revascularization | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Stroke or transient ischemic attack (TIA) | Number of patients experiencing stroke or transient ischemic attack (TIA) | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Angina status (Seattle questionnaire), CCS and NYHA class | Number of patients experiencing CCS and NYHA class | 30 days and 1 year | |
Secondary | Bleeding | Number of patients experiencing bleeding | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Quality of Life | Number of patients experiencing improvement in Quality of life | 30 days and 1 year | |
Secondary | Acute kidney injury | Number of patients experiencing acute kidney injury | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Target vessel revascularization | Number of patients experiencing target vessel revascularization | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Target lession revascularization | Number of patients experiencing target lession revascularization | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Cost effectiveness analysis | Cost effectiveness analysis | Until the last included patients have been followed for 1 year after the TAVI | |
Secondary | Stent thrombosis | Number of patients experiencing stent thrombosis | Until the last included patients have been followed for 1 year after the TAVI |
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