Coronary Artery DiseaseNOTION-3NCT03058627

Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation

A study testing PCI in people with Coronary Artery Disease and Aortic Valve Stenosis, run by Thomas Engstrom at 12 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Aortic Valve Stenosis, TAVI
What is being tested?: PCI
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 454 participants
Where: 12 sitesin 4 countries
Study dates: 15 Sep 2017to 15 Nov 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years
Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team
At least one stenosis with FFR ≤ 0.80 or diameter stenosis > 90% in a coronary artery ≥ 2.5 mm in diameter

Who cannot join

Life expectancy < 1 year due to other severe non-cardiac disease
Severe renal failure with estimated glomerular filtration rate < 20 ml/min
No PCI-eligible coronary artery stenosis, but rotablation is allowed
Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days
Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx))
Only stenoses with thrombolysis in myocardial infarction grad < 3

Show all 9Show fewer

Potential pregnancy
Known allergy towards P2Y12 receptor antagonists, heparin or contrast medium
More than one chronic total occlusion (CTO)

Trial locations and contacts

12 sites in 4 countries.

Country

City, postcode or hospital

12 sites in 4 countries

Denmark4 sites

Aalborg University Hospital
Aalborg
Department of Cardiology, Skejby University Hospital
Aarhus, 8200
Rigshospitalet, Copenhagen University Hospital
Copenhagen
Department of Cardiology, Odense University Hospital
Odense, 5000

Other trials in Denmark

Finland4 sites

Helsinki University Hospital
Helsinki
Oulu University Hospital
Oulu
Tampere University Hospital
Tampere
Turku University Hospital
Turku

Other trials in Finland

Sweden3 sites

Sahlgrenska
Gothenburg
Lund University Hospital
Lund
Karolinska
Stockholm

Other trials in Sweden

Latvia1 site

Riga University Hospital
Riga

Other trials in Latvia

About this study

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

Conditions: Coronary Artery Disease, Aortic Valve Stenosis, TAVI, PCI
Being tested: PCI
Medical subject headings: Coronary Artery Disease, Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PCIProcedure or surgery
FFR guided PCI

Study groups in NCT03058627
Study group	Role	What they receive
TAVI only	No intervention	TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.
TAVI + FFR-guided complete revascularization	Experimental	TAVI is performed according to current guidelines and the choice of transcatheter heart valve is at the operators' discretion. PCI is performed in any suitable lesion with diameter stenosis > 90% or FFR ≤ 0.80 in vessels ≥ 2.5 mm in diameter . Receives: Procedure: PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

All-cause mortality, myocardial infarction, or urgent revascularization
Number of patients experiencing all-cause mortality, myocardial infarction, or urgent PCI
Measured: Until the last included patients have been followed for 1 year after the TAVI

Secondary outcomes (20)

All cause mortality
Number of patients experiencing all cause mortality
Measured: Until the last included patients have been followed for 1 year after the TAVI
Myocardial infarction
Number of patients experiencing myocardial infarction
Measured: Until the last included patients have been followed for 1 year after the TAVI
Urgent revascularization
Number of patients experiencing urgent revascularization
Measured: Until the last included patients have been followed for 1 year after the TAVI
All cause mortality or myocardial infarction
Number of patients experiencing all cause mortality or myocardial infarction
Measured: Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality
Number of patients experiencing cardiovascular mortality
Measured: Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality, myocardial infarction, or urgent PCI
Number of patients experiencing cardiovascular mortality, myocardial infarction, or urgent PCI
Measured: Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality or myocardial infarction
Number of patients experiencing cardiovascular mortality or myocardial infarction
Measured: Until the last included patients have been followed for 1 year after the TAVI
Admission for new onset of heart failure
Number of patients experiencing admission for new onset of heart failure
Measured: Until the last included patients have been followed for 1 year after the TAVI
Peri-procedural (PCI) myocardial infarction
Number of patients experiencing peri-procedural (PCI) myocardial infarction
Measured: Until the last included patients have been followed for 1 year after the TAVI
Peri-procedural (TAVI) myocardial infarction
Number of patients experiencing peri-procedural (TAVI) myocardial infarction
Measured: Until the last included patients have been followed for 1 year after the TAVI
Any revascularization
Number of patients experiencing any revascularization
Measured: Until the last included patients have been followed for 1 year after the TAVI
Stroke or transient ischemic attack (TIA)
Number of patients experiencing stroke or transient ischemic attack (TIA)
Measured: Until the last included patients have been followed for 1 year after the TAVI
Angina status (Seattle questionnaire), CCS and NYHA class
Number of patients experiencing CCS and NYHA class
Measured: 30 days and 1 year
Bleeding
Number of patients experiencing bleeding
Measured: Until the last included patients have been followed for 1 year after the TAVI
Quality of Life
Number of patients experiencing improvement in Quality of life
Measured: 30 days and 1 year
Acute kidney injury
Number of patients experiencing acute kidney injury
Measured: Until the last included patients have been followed for 1 year after the TAVI
Target vessel revascularization
Number of patients experiencing target vessel revascularization
Measured: Until the last included patients have been followed for 1 year after the TAVI
Target lession revascularization
Number of patients experiencing target lession revascularization
Measured: Until the last included patients have been followed for 1 year after the TAVI
Cost effectiveness analysis
Cost effectiveness analysis
Measured: Until the last included patients have been followed for 1 year after the TAVI
Stent thrombosis
Number of patients experiencing stent thrombosis
Measured: Until the last included patients have been followed for 1 year after the TAVI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 201715 Nov 2027

First posted23 Feb 2017
Study start15 Sep 2017
Primary completion15 Jan 2024 (estimated)
Study completion15 Nov 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 454 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03058627
Sponsor's protocol ID: H-16039929
Acronym: NOTION-3
Status last verified: Dec 2023
First submitted: 11 Feb 2017
Last updated: 19 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jorgensen TH, Engstrom T, Jabbari R, Glinge C, Sabbah M, Veien KT, Niemela M, Freeman P, Linder R, Sorensen R, Holmvang L, Ioanes D, Terkelsen CJ, Ellert-Gregersen J, Christiansen EH, Eftekhari A, Piuhola J, Kajander O, Koul S, Savontaus M, Karjalainen P, Sondergaard L, De Backer O, Lonborg J. Fractional Flow Reserve to Guide Revascularization in Patients With Coronary Artery Disease Undergoing TAVR. JACC Cardiovasc Interv. 2025 Dec 8;18(23):2925-2936. doi: 10.1016/j.jcin.2025.10.015.
PubMed 41371788
Lonborg J, Jabbari R, Sabbah M, Veien KT, Niemela M, Freeman P, Linder R, Ioanes D, Terkelsen CJ, Kajander OA, Koul S, Savontaus M, Karjalainen P, Erglis A, Minkkinen M, Sorensen R, Tilsted HH, Holmvang L, Bieliauskas G, Ellert J, Piuhola J, Eftekhari A, Angeras O, Ruck A, Christiansen EH, Jorgensen T, Ozbek BT, Glinge C, Sondergaard L, De Backer O, Engstrom T; NOTION-3 Study Group. PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2024 Dec 12;391(23):2189-2200. doi: 10.1056/NEJMoa2401513. Epub 2024 Aug 31.
PubMed 39216095

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Coronary Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03058627
Acronym / sponsor ID: NOTION-3 / H-16039929
Conditions: Coronary Artery Disease, Aortic Valve Stenosis, TAVI, PCI
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 454 participants (actual)
Lead sponsor: Thomas EngstromUniversity, hospital or other
Collaborators: Copenhagen University Hospital, Rigshospitalet, 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
Study start: 15 Sep 2017 (actual)
Primary completion: 15 Jan 2024 (estimated)
Study completion: 15 Nov 2027 (estimated)
First posted: 23 Feb 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TAVI only	No intervention	–TAVI is performed according to current guidelines and the choice of valve prosthesis is at the operators' discretion.
TAVI + FFR-guided complete revascularization	Experimental	Procedure: PCITAVI is performed according to current guidelines and the choice of transcatheter heart valve is at the operators' discretion. PCI is performed in any suitable lesion with diameter stenosis > 90% or FFR ≤ 0.80 in vessels ≥ 2.5 mm in diameter .

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age ≥ 18 years
Severe aortic valve stenosis and selected for TAVI by a multi-disciplinary Heart Team
At least one stenosis with FFR ≤ 0.80 or diameter stenosis > 90% in a coronary artery ≥ 2.5 mm in diameter

Key exclusion criteria (9 listed)

Life expectancy < 1 year due to other severe non-cardiac disease
Severe renal failure with estimated glomerular filtration rate < 20 ml/min
No PCI-eligible coronary artery stenosis, but rotablation is allowed
Admitted with a new acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-STEMI) within 14 days
Significant stenosis in left main stenosis or ostial left anterior descending artery (LAD) + ostial left circumflex artery (LCx))

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PCIFFR guided PCI	Procedure or surgery	TAVI + FFR-guided complete revascularization

Primary outcome

All-cause mortality, myocardial infarction, or urgent revascularization
Time frame: 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

20 secondary outcomes

All cause mortality
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Myocardial infarction
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Urgent revascularization
Time frame: Until the last included patients have been followed for 1 year after the TAVI
All cause mortality or myocardial infarction
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality, myocardial infarction, or urgent PCI
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Cardiovascular mortality or myocardial infarction
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Admission for new onset of heart failure
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Peri-procedural (PCI) myocardial infarction
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Peri-procedural (TAVI) myocardial infarction
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Any revascularization
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Stroke or transient ischemic attack (TIA)
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Angina status (Seattle questionnaire), CCS and NYHA class
Time frame: 30 days and 1 year
Bleeding
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Quality of Life
Time frame: 30 days and 1 year
Acute kidney injury
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Target vessel revascularization
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Target lession revascularization
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Cost effectiveness analysis
Time frame: Until the last included patients have been followed for 1 year after the TAVI
Stent thrombosis
Time frame: Until the last included patients have been followed for 1 year after the TAVI

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
Derived from this study: PubMed 41371788Jorgensen TH, Engstrom T, Jabbari R, Glinge C, Sabbah M, Veien KT, Niemela M, Freeman P, Linder R, Sorensen R, Holmvang L, Ioanes D, Terkelsen CJ, Ellert-Gregersen J, Christiansen EH, Eftekhari A, Piuhola J, Kajander O, Koul S, Savontaus M, Karjalainen P, Sondergaard L, De Backer O, Lonborg J. Fractional Flow Reserve to Guide Revascularization in Patients With Coronary Artery Disease Undergoing TAVR. JACC Cardiovasc Interv. 2025 Dec 8;18(23):2925-2936. doi: 10.1016/j.jcin.2025.10.015.
Derived from this study: PubMed 39216095Lonborg J, Jabbari R, Sabbah M, Veien KT, Niemela M, Freeman P, Linder R, Ioanes D, Terkelsen CJ, Kajander OA, Koul S, Savontaus M, Karjalainen P, Erglis A, Minkkinen M, Sorensen R, Tilsted HH, Holmvang L, Bieliauskas G, Ellert J, Piuhola J, Eftekhari A, Angeras O, Ruck A, Christiansen EH, Jorgensen T, Ozbek BT, Glinge C, Sondergaard L, De Backer O, Engstrom T; NOTION-3 Study Group. PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation. N Engl J Med. 2024 Dec 12;391(23):2189-2200. doi: 10.1056/NEJMoa2401513. Epub 2024 Aug 31.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Engstrøm, MD, DMSC, PhD study chair

Rigshospitalet University Hospital, Denmark

Jacob Lønborg, MD, DMSC, PhD principal investigator

Rigshospitalet University Hospital, Denmark

Lars Søndergaard, MD, DMSc, PhD study chair

Rigshospitalet University Hospital, Denmark

12 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PCI in people with Coronary Artery Disease and Aortic Valve Stenosis, run by Thomas Engstrom at 12 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Denmark, Finland, Sweden, Latvia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality, myocardial infarction, or urgent revascularization (time frame: Until the last included patients have been followed for 1 year after the TAVI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03058627, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.