Coronary Artery DiseaseFAITAVINCT03360591
Functional Assessment in TAVI: FAITAVI
A study testing Physiologically-guided strategy in people with Coronary Artery Disease and Aortic Valve Stenosis, run by Universita di Verona at 1 site in Italy.
Trial summary
The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated according to two different strategies: 1. the Angiographically-guided strategy; 2. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Aortic Valve Stenosis
- What is being tested?
- Physiologically-guided strategy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteItaly
- Study dates
- 24 Nov 2017to Jun 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Written informed consent
- Diagnosis of severe native aortic valve disease with the indication to endovascular valve replacement given by Heart Team
- Diagnosis of at least one coronary stenosis >50% at angiography
- No specific pharmacologic treatment is required to enter the study
Who cannot join
- Age < 18 years
- Pregnancy
- Lack of informed consent
- Impaired left ventricular function
- Signs or symptoms of acute (unstable) myocardial ischemia
- Contraindication to adenosine administration (e.g., asthma, chronic obstructive pulmonary disease, heart rate <50 beats/min, and systolic blood pressure <90 mmHg)
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- Reduced survival expectancy due to severe co-morbidities (<1 year)
- Impossibility to obtain follow-up information
- The lack of any of inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated according to two different strategies:
- the Angiographically-guided strategy;
- the Physiologically-guided strategy.
Read the detailed description
Nowadays there are no clear recommendations about treatment of coronary in patients with severe aortic valve stenosis eligible for percutaneous valve replacement, and those available rely on a "common sense", class C, level of evidence. No randomized trials debride the skein about the best strategy of revascularization in this complex group of patients. In particular, it remains unclear whether it is preferable a preventive treatment or an ischemia-driven revascularization and, in addition, if it is safer and better for patient's health a simultaneous or a staged strategy.
The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated according to two different strategies.
The Angiographically-guided strategy is that of aiming the most complete degree of revascularization based on angiographic evaluation (stenting all coronary stenosis of major branches >2.5mm, with a %DS>50% as evaluated by visual estimation).
The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and leaving on optimal medical treatment lesions with FFR >0.80. The iFR values will be recorded in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating the 0.80 FFR cut-off with different iFR cut-off values, according to recent observations and using the same study end-points.
Particular attention will be dedicated to the eventual occurrence of clinical events in patients deferred on the bases of FFR values >0.80 that show a discrepancy with positive (<0.89) iFR values to investigate the reliability of the FFR in the Aortic Stenosis setting.
Both groups will receive the same TAVI strategy and optimal medical therapy. The study is designed as randomized, prospective, multi.center, open label, experimental trial with medical device. After discharge patients will be contacted at 30 days, 6 - 12 and 24 months after the procedure to assess the general clinical status and at 12 months to assess the occurrence of events included in the primary and secondary endpoints. The duration of study participation is 24 months for enrolment, ad 24 months for final follow-up.
- Conditions
- Coronary Artery Disease, Aortic Valve Stenosis
- Being tested
- Physiologically-guided strategy
- 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.
Physiologically-guided strategyDevice
Also called Angiographically-guided strategy
The Angiographically-guided strategy is that of aiming the most complete degree of revascularization based on angiographic evaluation (stenting all coronary stenosis of major branches >2.5mm, with a % coronary stenosis>50% as evaluated by visual estimation.
The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and leaving on optimal medical treatment lesions with FFR >0.80. The iFR values will be recorded in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating the 0.80 FFR cut-off with different iFR cut-off values, and using the same study end-points.
Particular attention will be dedicated to the eventual occurrence of clinical events in patients deferred on the bases of FFR values >0.80 that show a discrepancy with positive (<0.89) iFR values to investigate the reliability of the FFR in the aortic stenosis setting. Both groups will receive the same TAVI strategy and optimal medical therapy
| Study group | Role | What they receive |
|---|---|---|
| Physiologically-guided strategy | Experimental | Patients randomized in this group will undergo stenting of coronary lesions showing FFR values ≤0.80 only.
* Lesions showing positive FFR measurements (<0.80) must be treated with PCI, before or after TAVI.
* Lesions showing clearly negative values (FFR >0.80) will not be treated with PCI before TAVI, and repeated FFR and iFR measurements after TAVI are strongly recommended.
* Lesions showing "borderline" FFR measurements before TAVI (FFR 0.80-0.83), should be measured again (both FFR and iFR) after TAVI, and the decision of treating of deferring treatment in a given lesion will be based on the FFR value obtained after TAVI.
* In all cases iFR values will be recorded for a post hoc analysis and for validation of the study endpoints according to iFR values. Receives: Device: Physiologically-guided strategy |
| Angiographically-guided strategy | Other | Patients allocated in this group will undergo stenting of all coronary stenosis ≥50% as assessed by visual estimation in vessels ≥2.5mm. PCI can be performed before in a previous procedure, or after TAVI, but always within one month, ± 5 days of the valve implantation.PCI in the group randomized to the angio-guided procedure can be performed therefore, either before or after valve implantation, in the same or in different procedures. Implantation of second-generation drug eluting stents (DES) in all interventions is advised, but not mandatory, and the brand of the stent is left to the operators and center's choice. Receives: Device: Physiologically-guided strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the treatment
Composite of all-cause death, myocardial infarction, stroke, major bleeding, need for target vessel revascularization as adjudicated by the Clinical Event Committee
Measured: 12 months
Secondary outcomes (1)
Safety endpoint
Composite of all cause mortality, all strokes (disabling and not disabling), life threatening bleeding, AKI (stages 2 or 3, including need for dialysis), coronary artery obstruction requiring intervention, major vascular complication, valve related dysfunction requiring repeat procedure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start24 Nov 2017
- Primary completion30 Jun 2024
- Study completionJun 2025 (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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavio Ribichini, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360591
- Sponsor's protocol ID
- FAITAVI
- Acronym
- FAITAVI
- Status last verified
- May 2024
- First submitted
- 28 Nov 2017
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ribichini FL, Scarsini R, Pesarini G, Fabris T, Barbierato M, D'Amico G, Zanchettin C, Gregori D, Lorenzoni G, Piva T, Nicolini E, Gandolfo C, La Spina K, Fineschi M, Gallo F, Baccani B, Petronio AS, De Carlo M, Berti S, Drago A, Saia F, Sclafani R, Esposito G, D'Ascenzo F, Tarantini G; FAITAVI Trial investigators. Physiology vs angiography-guided percutaneous coronary intervention in transcatheter aortic valve implantation: the FAITAVI trial. Eur Heart J. 2026 Jul 1;47(25):3257-3266. doi: 10.1093/eurheartj/ehaf974.
PubMed 41417623Ribichini F, Pesarini G, Fabris T, Lunardi M, Barbierato M, D'Amico G, Zanchettin C, Gregori D, Piva T, Nicolini E, Gandolfo C, Fineschi M, Petronio AS, Berti S, Caprioglio F, Saia F, Sclafani R, Esposito G, D'Ascenzo F, Tarantini G. A randomised multicentre study of angiography- versus physiologyguided percutaneous coronary intervention in patients with coronary artery disease undergoing TAVI: design and rationale of the FAITAVI trial. EuroIntervention. 2024 Apr 15;20(8):e504-e510. doi: 10.4244/EIJ-D-23-00679.
PubMed 38629420
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Assessment in TAVI: FAITAVI
- ClinicalTrials.gov ID
- NCT03360591
- Acronym / sponsor ID
- FAITAVI / FAITAVI
- Conditions
- Coronary Artery Disease, Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 4 Dec 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.
The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated according to two different strategies:
- the Angiographically-guided strategy;
- the Physiologically-guided strategy.
Detailed description
Nowadays there are no clear recommendations about treatment of coronary in patients with severe aortic valve stenosis eligible for percutaneous valve replacement, and those available rely on a "common sense", class C, level of evidence. No randomized trials debride the skein about the best strategy of revascularization in this complex group of patients. In particular, it remains unclear whether it is preferable a preventive treatment or an ischemia-driven revascularization and, in addition, if it is safer and better for patient's health a simultaneous or a staged strategy.
The aim of this study is to compare the clinical outcome of patients with severe aortic valve stenosis and associated significant coronary artery disease treated with TAVI and a percutaneous myocardial revascularization dictated according to two different strategies.
The Angiographically-guided strategy is that of aiming the most complete degree of revascularization based on angiographic evaluation (stenting all coronary stenosis of major branches >2.5mm, with a %DS>50% as evaluated by visual estimation).
The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and leaving on optimal medical treatment lesions with FFR >0.80. The iFR values will be recorded in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating the 0.80 FFR cut-off with different iFR cut-off values, according to recent observations and using the same study end-points.
Particular attention will be dedicated to the eventual occurrence of clinical events in patients deferred on the bases of FFR values >0.80 that show a discrepancy with positive (<0.89) iFR values to investigate the reliability of the FFR in the Aortic Stenosis setting.
Both groups will receive the same TAVI strategy and optimal medical therapy. The study is designed as randomized, prospective, multi.center, open label, experimental trial with medical device. After discharge patients will be contacted at 30 days, 6 - 12 and 24 months after the procedure to assess the general clinical status and at 12 months to assess the occurrence of events included in the primary and secondary endpoints. The duration of study participation is 24 months for enrolment, ad 24 months for final follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiologically-guided strategy | Experimental | Device: Physiologically-guided strategyPatients randomized in this group will undergo stenting of coronary lesions showing FFR values ≤0.80 only. * Lesions showing positive FFR measurements (<0.80) must be treated with PCI, before or after TAVI. * Lesions showing clearly negative values (FFR >0.80) will not be treated with PCI before TAVI, and repeated FFR and iFR measurements after TAVI are strongly recommended. * Lesions showing "borderline" FFR measurements before TAVI (FFR 0.80-0.83), should be measured again (both FFR and iFR) after TAVI, and the decision of treating of deferring treatment in a given lesion will be based on the FFR value obtained after TAVI. * In all cases iFR values will be recorded for a post hoc analysis and for validation of the study endpoints according to iFR values. |
| Angiographically-guided strategy | Other | Device: Physiologically-guided strategyPatients allocated in this group will undergo stenting of all coronary stenosis ≥50% as assessed by visual estimation in vessels ≥2.5mm. PCI can be performed before in a previous procedure, or after TAVI, but always within one month, ± 5 days of the valve implantation.PCI in the group randomized to the angio-guided procedure can be performed therefore, either before or after valve implantation, in the same or in different procedures. Implantation of second-generation drug eluting stents (DES) in all interventions is advised, but not mandatory, and the brand of the stent is left to the operators and center's choice. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Written informed consent
- Diagnosis of severe native aortic valve disease with the indication to endovascular valve replacement given by Heart Team
- Diagnosis of at least one coronary stenosis >50% at angiography
- No specific pharmacologic treatment is required to enter the study
Key exclusion criteria (9 listed)
- Age < 18 years
- Pregnancy
- Lack of informed consent
- Impaired left ventricular function
- Signs or symptoms of acute (unstable) myocardial ischemia
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 |
|---|---|---|
| Physiologically-guided strategyAlso: Angiographically-guided strategyThe Angiographically-guided strategy is that of aiming the most complete degree of revascularization based on angiographic evaluation (stenting all coronary stenosis of major branches >2.5mm, with a % coronary stenosis>50% as evaluated by visual estimation. The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and leaving on optimal medical treatment lesions with FFR >0.80. The iFR values will be recorded in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating the 0.80 FFR cut-off with different iFR cut-off values, and using the same study end-points. Particular attention will be dedicated to the eventual occurrence of clinical events in patients deferred on the bases of FFR values >0.80 that show a discrepancy with positive (<0.89) iFR values to investigate the reliability of the FFR in the aortic stenosis setting. Both groups will receive the same TAVI strategy and optimal medical therapy | Device | Angiographically-guided strategy, Physiologically-guided strategy |
Primary outcome
Incidence of the treatment
Time frame: 12 months
Composite of all-cause death, myocardial infarction, stroke, major bleeding, need for target vessel revascularization as adjudicated by the Clinical Event Committee
1 secondary outcome
Safety endpoint
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 41417623Ribichini FL, Scarsini R, Pesarini G, Fabris T, Barbierato M, D'Amico G, Zanchettin C, Gregori D, Lorenzoni G, Piva T, Nicolini E, Gandolfo C, La Spina K, Fineschi M, Gallo F, Baccani B, Petronio AS, De Carlo M, Berti S, Drago A, Saia F, Sclafani R, Esposito G, D'Ascenzo F, Tarantini G; FAITAVI Trial investigators. Physiology vs angiography-guided percutaneous coronary intervention in transcatheter aortic valve implantation: the FAITAVI trial. Eur Heart J. 2026 Jul 1;47(25):3257-3266. doi: 10.1093/eurheartj/ehaf974.
- Derived from this study: PubMed 38629420Ribichini F, Pesarini G, Fabris T, Lunardi M, Barbierato M, D'Amico G, Zanchettin C, Gregori D, Piva T, Nicolini E, Gandolfo C, Fineschi M, Petronio AS, Berti S, Caprioglio F, Saia F, Sclafani R, Esposito G, D'Ascenzo F, Tarantini G. A randomised multicentre study of angiography- versus physiologyguided percutaneous coronary intervention in patients with coronary artery disease undergoing TAVI: design and rationale of the FAITAVI trial. EuroIntervention. 2024 Apr 15;20(8):e504-e510. doi: 10.4244/EIJ-D-23-00679.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiologically-guided strategy in people with Coronary Artery Disease and Aortic Valve Stenosis, run by Universita di Verona at 1 site in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Results are not available in the source record.
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?
Incidence of the treatment (time frame: 12 months). 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 NCT03360591, 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 21 Mar 2025.