NCT03058627

Brief 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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
454

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
19mo left

Started Sep 2017

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
4 countries

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Sep 2017Nov 2027

First Submitted

Initial submission to the registry

February 11, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

September 15, 2017

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2027

Expected
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

6.3 years

First QC Date

February 11, 2017

Last Update Submit

December 18, 2023

Conditions

Coronary Artery DiseaseAortic Valve StenosisTAVIPCI

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (20)

  • All cause mortality

    Until the last included patients have been followed for 1 year after the TAVI

  • Myocardial infarction

    Until the last included patients have been followed for 1 year after the TAVI

  • Urgent revascularization

    Until the last included patients have been followed for 1 year after the TAVI

  • All cause mortality or myocardial infarction

    Until the last included patients have been followed for 1 year after the TAVI

  • Cardiovascular mortality

    Until the last included patients have been followed for 1 year after the TAVI

  • +15 more secondary outcomes

Study Arms (2)

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 .

Procedure: PCI

Interventions

PCIPROCEDURE

FFR guided PCI

TAVI + FFR-guided complete revascularization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Aalborg University Hospital

Aalborg, Denmark

Location

Department of Cardiology, Skejby University Hospital

Aarhus, 8200, Denmark

Location

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Location

Department of Cardiology, Odense University Hospital

Odense, 5000, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Riga University Hospital

Riga, Latvia

Location

Sahlgrenska

Gothenburg, Sweden

Location

Lund University Hospital

Lund, Sweden

Location

Karolinska

Stockholm, Sweden

Location

Related Publications (2)

  • 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 E, 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.

    PMID: 41371788DERIVED

  • 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.

    PMID: 39216095DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAortic Valve Stenosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAortic Valve DiseaseHeart Valve DiseasesVentricular Outflow Obstruction

Study Officials

  • Thomas Engstrøm, MD, DMSC, PhD

    Rigshospitalet University Hospital, Denmark

    STUDY CHAIR

  • Jacob Lønborg, MD, DMSC, PhD

    Rigshospitalet University Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • Lars Søndergaard, MD, DMSc, PhD

    Rigshospitalet University Hospital, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant, PhD, DMSci

Study Record Dates

First Submitted

February 11, 2017

First Posted

February 23, 2017

Study Start

September 15, 2017

Primary Completion

January 15, 2024

Study Completion (Estimated)

November 15, 2027

Last Updated

December 19, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

FI(4)DK(4)LA(1)SE(3)