NCT03424941

Brief Summary

The trial objective is to investigate whether Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention (PCI) and TransCatheter Aortic Valve Implantation (TAVI) strategy for treatment of multivessel disease and aortic stenosis will be non-inferior to Coronary Artery By-pass Grafting (CABG) and Surgical Aortic Valve Replacement (SAVR) for a composite primary endpoint of all-cause mortality, stroke, myocardial infarction, coronary or valve re-intervention and life-threatening or disabling bleeding at one year.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
10 countries

20 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 9, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2024

Completed
Last Updated

January 9, 2025

Status Verified

January 1, 2025

Enrollment Period

6.1 years

First QC Date

January 9, 2018

Last Update Submit

January 7, 2025

Conditions

Aortic StenosisMulti Vessel Coronary Artery DiseaseTAVICABGPCIFractional Flow Reserve

Keywords

Aortic Stenosis (AS)Multi Vessel Coronary Artery Disease (MVD)TransCatheter Aortic Valve Implantation (TAVI)Coronary Artery By-pass Grafting (CABG)Percutaneous Coronary Intervention (PCI)Fractional Flow Reserve (FFR)Surgical Aortic Valve Replacement (SAVR)

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint is a composite of all-cause mortality, myocardial infarction, disabling stroke, unscheduled clinically-driven target vessel revascularization, valve re-intervention, and life threatening or disabling bleeding at one year

    one year

Secondary Outcomes (17)

  • Major Adverse Cardiac Events (MACE: a composite of cardiovascular mortality, all stroke, myocardial infarction, unscheduled coronary or valve re-intervention) at one year

    one year

  • All-cause mortality and all stroke at 30 days and at one year

    30 days and one year

  • Life-threatening or disabling bleeding at 30 days and one year

    30 days and one year

  • Life-threatening or disabling bleeding and major bleeding at 30 days and at one year

    30 days and one year

  • Rate of conduction disturbances requiring a permanent pacemaker at 30 days and at one year

    30 days and one year

  • +12 more secondary outcomes

Study Arms (2)

FFR-guided PCI and TAVI

EXPERIMENTAL

FFR-guided PCI and subsequently TAVI treatment with the Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO

Device: FFR-guided PCI and TAVI

CABG and SAVR

ACTIVE COMPARATOR

CABG and SAVR

Device: CABG and SAVR

Interventions

FFR-guided PCI and TAVIDEVICE

Treatment of subjects with multivessel coronary artery disease and aortic stenosis for FFR-guided PCI and TAVI (Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO)

FFR-guided PCI and TAVI
CABG and SAVRDEVICE

Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR

CABG and SAVR

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Symptomatic patients aged ≥70 years with aortic stenosis fulfilling one of these criteria (Aortic Valve Area (AVA) ≤1 cm2; mean gradient ≥40 mmHg; Aortic jet velocity \>4 m/sec; or Velocity index ≤ 0.25) feasible for treatment by both trans femoral or subclavian approach TAVI as well as conventional SAVR and where the Heart Team decides that treatment is needed (final decision is left to the Heart Team)
  • Presence of ≥2 de novo coronary lesions of ≥50% diameter stenosis on visual estimation located in any of main epicardial coronary arteries, or side branches of a lumen caliber of more than 2 mm or single Left Anterior Descending (LAD) lesion with more than 20 mm length or involving a bifurcation (complex), feasible for treatment with CABG as well as PCI (Heart Team decision)
  • Patients willing and capable to provide written informed consent

You may not qualify if:

  • Patients in cardiogenic shock or acute heart failure, requiring inotropic agents during procedure and/or i.v. diuretics \<48 hours before procedure
  • Left ventricular ejection fraction \<30%
  • Concomitant presence of other than aortic valve disease requiring intervention
  • Previous CABG, SAVR, TAVI or thoracotomy for any other reason
  • Bicuspid or unicuspid aortic valve
  • Recent myocardial infarction (less than 2 weeks)
  • Involvement of left main trifurcation (all three branches being larger than 2 mm)
  • Expected total stent length more 60mm per vessel
  • FFR measurement judged impossible
  • Life expectancy \<1 year
  • Known malignancy
  • Contraindication for dual antiplatelet therapy or expected surgical intervention requiring interruption of Dual Antiplatelet Therapy (DAPT) in the first 6 months
  • Reduced renal function (Glomerular Filtration Rate (GFR) \<29 ml/min/1.73m2; Kidney Disease Outcomes Quality Initiative (KDOQI) stage 4 and 5)
  • Previous disabling stroke, Transient Ischemic Attack (TIA) in the last 6 months, or known severe stenosis of carotid or vertebral arteries
  • Participation in other investigational clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Medical University of Graz

Graz, Austria

Location

General Hospital Vienna

Vienna, Austria

Location

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Denmark

Location

CHU de Bordeaux

Bordeaux, France

Location

CHRU de Lille

Lille, France

Location

Clinique Pasteur

Toulouse, France

Location

Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH

Hamburg, Germany

Location

Onassis Cardiac Surgery Center

Kallithea, Greece

Location

OLVG

Amsterdam, Netherlands

Location

UMCG

Groningen, Netherlands

Location

St. Antonius hospital

Nieuwegein, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

Hagaziekenhuis

The Hague, Netherlands

Location

Isala hospital

Zwolle, Netherlands

Location

Medical University of Silesia

Katowice, Poland

Location

University hospital Opole

Opole, Poland

Location

Hospital de Santa Cruz

Lisbon, Portugal

Location

SUSCCH

Banská Bystrica, Slovakia

Location

Hospital Clinico Universitario San Carlos

Madrid, Spain

Location

Hospital Clínico Valladolid

Valladolid, Spain

Location

Related Publications (2)

  • Kedhi E, Hermanides RS, Dambrink JE, Singh SK, Ten Berg JM, van Ginkel D, Hudec M, Amoroso G, Amat-Santos IJ, Andreas M, Campante Teles R, Bonnet G, Van Belle E, Conradi L, van Garsse L, Wojakowski W, Voudris V, Sacha J, Cervinka P, Lipsic E, Somi S, Nombela-Franco L, Postma S, Piayda K, De Luca G, Kolkman E, Malinowski KP, Modine T; TCW study group. TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and complex or multivessel coronary disease (TCW): an international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial. Lancet. 2025 Dec 21;404(10471):2593-2602. doi: 10.1016/S0140-6736(24)02100-7. Epub 2024 Dec 4.

    PMID: 39644913DERIVED

  • Kedhi E, Rroku A, Hermanides RS, Dambrink JH, Singh S, Berg JT, van Ginkel DJ, Hudec M, Amoroso G, Amat-Santos IJ, Andreas M, Teles RC, Bonnet G, Van Belle E, Conradi L, van Garsse L, Wojakowski W, Voudris V, Sacha J, Cervinka P, Lipsic E, Somi S, Nombela-Franco L, Postma S, Piayda K, De Luca G, Malinofski K, Modine T. TransCatheter aortic valve implantation and fractional flow reserve-guided percutaneous coronary intervention versus conventional surgical aortic valve replacement and coronary bypass grafting for treatment of patients with aortic valve stenosis and multivessel or advanced coronary disease: The transcatheter valve and vessels trial (TCW trial): Design and rationale. Am Heart J. 2024 Apr;270:86-94. doi: 10.1016/j.ahj.2024.01.010. Epub 2024 Feb 1.

    PMID: 38309610DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • prof. Elvin Kedhi, MD, PhD

    Hopital Erasme, Brussels, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2018

First Posted

February 7, 2018

Study Start

May 31, 2018

Primary Completion

June 26, 2024

Study Completion

June 26, 2024

Last Updated

January 9, 2025

Record last verified: 2025-01

Locations

DK(1)PL(2)FR(3)ES(2)NL(6)GR(1)AU(2)DE(1)SL(1)PT(1)