Aortic StenosisTCWNCT03424941
The TransCatheter Valve and Vessels Trial
A study testing FFR-guided PCI and TAVI and CABG and SAVR in people with Aortic Stenosis and Multi Vessel Coronary Artery Disease, run by Maatschap Cardiologie Zwolle at 20 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Stenosis, Multi Vessel Coronary Artery Disease, TAVI
- What is being tested?
- FFR-guided PCI and TAVI and CABG and SAVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 20 sitesin 10 countries
- Study dates
- 31 May 2018to 26 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
20 sites in 10 countries.
20 sites in 10 countries
Netherlands6 sites
OLVG
Amsterdam
UMCG
Groningen
St. Antonius hospital
Nieuwegein
Radboudumc
Nijmegen
Hagaziekenhuis
The Hague
Isala hospital
Zwolle
France3 sites
CHU de Bordeaux
Bordeaux
CHRU de Lille
Lille
Clinique Pasteur
Toulouse
Poland2 sites
Medical University of Silesia
Katowice
University hospital Opole
Opole
Spain2 sites
Hospital Clinico Universitario San Carlos
Madrid
Hospital Clínico Valladolid
Valladolid
About this study
Official title: TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients with Coronary MultiVessel Disease and Aortic Valve Stenosis
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.
Read the detailed description
Prospective, randomized, controlled, open label, multicenter, international, non-inferiority trial
If the Heart Team decides that a coronary revascularization and aortic valve replacement is needed and the patient complies with inclusion and exclusion criteria then the patient will be randomized in a 1:1 fashion between FFR-guided PCI + TAVI and CABG + SAVR.
Patients will receive optimal medical treatment at discharge. Follow-up will be performed at 30 days and at one year. During the 30 day follow-up visit (after TAVI) patients will be evaluated for symptoms of angina.
- Conditions
- Aortic Stenosis, Multi Vessel Coronary Artery Disease, TAVI, CABG, PCI, Fractional Flow Reserve
- Being tested
- FFR-guided PCI and TAVI, CABG and SAVR
- 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)
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
CABG and SAVRDevice
Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: FFR-guided PCI and TAVI |
| CABG and SAVR | Active comparator | CABG and SAVR Receives: Device: CABG and SAVR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: one year
All-cause mortality and all stroke at 30 days and at one year
Measured: 30 days and one year
Life-threatening or disabling bleeding at 30 days and one year
Measured: 30 days and one year
Life-threatening or disabling bleeding and major bleeding at 30 days and at one year
Measured: 30 days and one year
Rate of conduction disturbances requiring a permanent pacemaker at 30 days and at one year
Measured: 30 days and one year
Access-related complications at 30 days
Measured: 30 days
Acute kidney injury (Acute Kidney Injury Network (AKIN) classification) at 30 days and at one year
Measured: 30 days and one year
Stent thrombosis according to Academic Research Consortium (ARC) criteria (definite and probable) at 30 days and at one year
Measured: 30 days and one year
Device success (Valve Academic Research Consortium (VARC) 2 definition)
Measured: procedure
Early Safety at 30 days (VARC 2 definition)
Measured: 30 days
Early Efficacy at 30 days (VARC 2 definition)
Measured: 30 days
Time Related Valve Safety at 30 days (VARC 2 definition)
Measured: 30 days
Echocardiographic assessment of prosthetic valve performance at discharge and at one year using the following measures: a) transvalvular mean gradient, b) Effective Orifice Area (EOA), c) degree of prosthetic aortic valve regurgitation
Measured: discharge and at one year
Clinically driven revascularisation at 30 days and at one year
Measured: 30 days and one year
Change in New York Heart Association (NYHA) class before treatment, at 30 days and at one year
Measured: 30 days and one year
Change in Canadian Cardiovascular Society (CCS) class before treatment, at 30 days and at one year
Measured: 30 days and one year
Quality of life (Short Form (SF)-36) before treatment and at one year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start31 May 2018
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
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 Aortic StenosisStudies 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
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maatschap Cardiologie Zwolle
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- prof. Elvin Kedhi, MD, PhD, Principal investigator, Hopital Erasme, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424941
- Sponsor's protocol ID
- 9283
- Acronym
- TCW
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2018
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39644913Kedhi 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.
PubMed 38309610
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TransCatheter Aortic Valve Implantation and Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Versus Conventional Surgical Aortic Valve Replacement and Coronary By-Pass Grafts for Treatment of Patients with Coronary MultiVessel Disease and Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT03424941
- Acronym / sponsor ID
- TCW / 9283
- Conditions
- Aortic Stenosis, Multi Vessel Coronary Artery Disease, TAVI, CABG, PCI, Fractional 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Maatschap Cardiologie ZwolleUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 31 May 2018 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 7 Feb 2018 (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.
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.
Detailed description
Prospective, randomized, controlled, open label, multicenter, international, non-inferiority trial
If the Heart Team decides that a coronary revascularization and aortic valve replacement is needed and the patient complies with inclusion and exclusion criteria then the patient will be randomized in a 1:1 fashion between FFR-guided PCI + TAVI and CABG + SAVR.
Patients will receive optimal medical treatment at discharge. Follow-up will be performed at 30 days and at one year. During the 30 day follow-up visit (after TAVI) patients will be evaluated for symptoms of angina.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FFR-guided PCI and TAVI | Experimental | Device: FFR-guided PCI and TAVIFFR-guided PCI and subsequently TAVI treatment with the Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO |
| CABG and SAVR | Active comparator | Device: CABG and SAVRCABG and SAVR |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| FFR-guided PCI and TAVITreatment 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) | Device | FFR-guided PCI and TAVI |
| CABG and SAVRTreatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR | Device | CABG and SAVR |
Primary outcome
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
Time frame: one year
17 secondary outcomes
Major Adverse Cardiac Events (MACE: a composite of cardiovascular mortality, all stroke, myocardial infarction, unscheduled coronary or valve re-intervention) at one year
Time frame: one year
All-cause mortality and all stroke at 30 days and at one year
Time frame: 30 days and one year
Life-threatening or disabling bleeding at 30 days and one year
Time frame: 30 days and one year
Life-threatening or disabling bleeding and major bleeding at 30 days and at one year
Time frame: 30 days and one year
Rate of conduction disturbances requiring a permanent pacemaker at 30 days and at one year
Time frame: 30 days and one year
Access-related complications at 30 days
Time frame: 30 days
Acute kidney injury (Acute Kidney Injury Network (AKIN) classification) at 30 days and at one year
Time frame: 30 days and one year
Stent thrombosis according to Academic Research Consortium (ARC) criteria (definite and probable) at 30 days and at one year
Time frame: 30 days and one year
Device success (Valve Academic Research Consortium (VARC) 2 definition)
Time frame: procedure
Early Safety at 30 days (VARC 2 definition)
Time frame: 30 days
Early Efficacy at 30 days (VARC 2 definition)
Time frame: 30 days
Time Related Valve Safety at 30 days (VARC 2 definition)
Time frame: 30 days
Echocardiographic assessment of prosthetic valve performance at discharge and at one year using the following measures: a) transvalvular mean gradient, b) Effective Orifice Area (EOA), c) degree of prosthetic aortic valve regurgitation
Time frame: discharge and at one year
Clinically driven revascularisation at 30 days and at one year
Time frame: 30 days and one year
Change in New York Heart Association (NYHA) class before treatment, at 30 days and at one year
Time frame: 30 days and one year
Change in Canadian Cardiovascular Society (CCS) class before treatment, at 30 days and at one year
Time frame: 30 days and one year
Quality of life (Short Form (SF)-36) before treatment and at one year
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Derived from this study: PubMed 39644913Kedhi 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.
- Derived from this study: PubMed 38309610Kedhi 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.
- Individual participant dataSharing planned: Undecided
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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.
prof. Elvin Kedhi, MD, PhD principal investigator
Hopital Erasme, Brussels, Belgium
20 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FFR-guided PCI and TAVI and CABG and SAVR in people with Aortic Stenosis and Multi Vessel Coronary Artery Disease, run by Maatschap Cardiologie Zwolle at 20 sites in 10 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 15 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: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Netherlands, France, Austria, Poland, Spain and 5 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 (time frame: one year). 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 NCT03424941, 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 9 Jan 2025.