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Functional Assessment In TAVI: FAITAVI (FAITAVI)

Primary Purpose

Coronary Artery Disease, Aortic Valve Stenosis

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Physiologically-guided strategy
Sponsored by
Universita di Verona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age > 18 years
  2. Written informed consent
  3. Diagnosis of severe native aortic valve disease with the indication to endovascular valve replacement given by Heart Team
  4. Diagnosis of at least one coronary stenosis >50% at angiography
  5. No specific pharmacologic treatment is required to enter the study

Exclusion Criteria:

  1. Age < 18 years
  2. Pregnancy
  3. Lack of informed consent
  4. Impaired left ventricular function
  5. Signs or symptoms of acute (unstable) myocardial ischemia
  6. Contraindication to adenosine administration (e.g., asthma, chronic obstructive pulmonary disease, heart rate <50 beats/min, and systolic blood pressure <90 mmHg)
  7. Reduced survival expectancy due to severe co-morbidities (<1 year)
  8. Impossibility to obtain follow-up information
  9. The lack of any of inclusion criteria

Sites / Locations

  • Azienda Ospedaliera Universitaria Integrata VeronaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Physiologically-guided strategy

Angiographically-guided strategy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2017
Last Updated
May 8, 2023
Sponsor
Universita di Verona
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1. Study Identification

Unique Protocol Identification Number
NCT03360591
Brief Title
Functional Assessment In TAVI: FAITAVI
Acronym
FAITAVI
Official Title
Functional Assessment In TAVI: FAITAVI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2017 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universita di Verona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Aortic Valve Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiologically-guided strategy
Arm Type
Experimental
Arm Description
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.
Arm Title
Angiographically-guided strategy
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Physiologically-guided strategy
Other Intervention Name(s)
Angiographically-guided strategy
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of the treatment
Description
Composite of all-cause death, myocardial infarction, stroke, major bleeding, need for target vessel revascularization as adjudicated by the Clinical Event Committee
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Safety endpoint
Description
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
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) Reduced survival expectancy due to severe co-morbidities (<1 year) Impossibility to obtain follow-up information The lack of any of inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flavio L Ribichini, MD
Phone
+39 045 812
Ext
2320
Email
flavio.ribichini@univr.it
Facility Information:
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavio

12. IPD Sharing Statement

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Functional Assessment In TAVI: FAITAVI

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