Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

Coronary Artery Disease Clinical Trial

— NOTION-3  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03058627
• Other study ID #: H-16039929
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 15, 2017
• Est. completion date: November 15, 2027

Study information

• Verified date: December 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• PCI
• TAVI

Intervention

Procedure:
• PCI
FFR guided PCI

Locations

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

Sponsors (14)

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

Countries where clinical trial is conducted

Denmark,  Finland,  Latvia,  Sweden, 

Outcome

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