Aortic Valve StenosisFORTUNANCT03665389
Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR
A study testing iFR / FFR measurement in people with Aortic Valve Stenosis and Coronary Artery Disease, run by Kobe University.
Trial summary
The objective of this study is to evaluate the relationship between fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRct) before transcatheter aortic valve replacement (TAVR) and FFR after TAVR so as to investigate whether FFRct is useful for evaluating myocardial ischemia of… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Coronary Artery Disease
- What is being tested?
- iFR / FFR measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 13 Sep 2018to 31 Mar 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Among patients who have undergone cCTA prior to TAVR, those with moderate stenotic lesions (30 to <70%) or severe stenotic lesions on CT who are candidates for percutaneous coronary intervention (PCI) following TAVR
- Patients aged 20 years or older at the time of diagnosis
Who cannot join
- Patients who meet any one of the following criteria will be excluded from this study:
- Patients who were implanted with metal stents in the left main trunk,
- Patients with stenosis of >30% in the left main trunk who were implanted with at least one metal stent in the vessel(s) of the left coronary circulation,
- Patients who were implanted with metal stents in at least 2 vessels of the coronary circulation,
- Patients who requested withdrawal of consent for participation in this research study after providing their consent,
- Patients who underwent coronary artery bypass surgery,
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- Patients with coronary artery chronic total occlusion,
- Patients who developed acute myocardial infarction in the past 2 months,
- Patients whose cCTA was determined to be unreadable during its evaluation at the study site because of the presence of artifacts which were severe enough to cause problems with the angiogram,
- Patients who were judged by the principal investigator to be unsuitable for the study for other reasons
About this study
Official title: Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing Transcatheter Aortic Valve Replacement（FORTUNA）: Single Center, Open-label, Exploratory, Prospective Study
The objective of this study is to evaluate the relationship between fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRct) before transcatheter aortic valve replacement (TAVR) and FFR after TAVR so as to investigate whether FFRct is useful for evaluating myocardial ischemia of severe AS. Furthermore, by measuring the instantaneous wave-free ratio (iFR) which is a physiological diagnostic method of coronary artery stenosis before and after TAVR and comparing iFR (iFR before and after TAVR) and FFR (FFR after TAVR) with FFRct (FFRct before and after TAVR), It also aims to deepen understanding of resting coronary artery physiology in aortic valve stenosis.
Read the detailed description
This is a single-center, open-label, exploratory, prospective study. Among patients who undergo coronary computed tomography angiography (cCTA) prior to TAVR, those with moderate or severe stenotic lesions will be included in the study. Patients from whom consent is obtained following TAVR will be enrolled in the study.
Among patients who undergo TAVR at the Kobe University Hospital from September 2018 to March 2022, those who are found to have moderate or severe stenosis on cCTA performed before surgery and judged to clinically require ischemia evaluation will be included in the study. At the time of pre-TAVR coronary angiogram, iFR (iFR before TAVR) will be measured. The cCTA data collected from patients whose consent is obtained following TAVR will be anonymized and sent to HeartFlow, Inc., where the FFRct（FFRct before TAVR) values will be calculated using their cardiovascular dynamics analysis program. FFR (FFR after TAVR) and iFR (iFR after TAVR) will be measured using a guide wire that is capable of sensing pressure after TAVR is performed. Furthermore, FFRct (FFRct after TAVR) is calculated from cCTA taken after TAVR.
- Conditions
- Aortic Valve Stenosis, Coronary Artery Disease
- Being tested
- iFR / FFR measurement
- Keywords
- FFRct, aortic stenosis
- Medical subject headings
- Aortic Valve Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFR / FFR measurementDevice
At the time of pre-TAVR coronary angiogram, iFR (iFR before TAVR) will be measured. The cCTA data collected from patients whose consent is obtained following TAVR will be anonymized and sent to HeartFlow, Inc., where the FFRct （FFRct before TAVR） values will be calculated using their cardiovascular dynamics analysis program. With the FFRct values blinded, FFR (FFR after TAVR) and iFR (iFR after TAVR) will be measured using a guide wire that is capable of sensing pressure after TAVR is performed. Furthermore, FFRct(FFRct after TAVR) is calculated from cCTA taken after TAVR.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Among patients who undergo TAVR at the kobe university hospital, those who are found to have moderate or severe stenosis on cCTA performed before surgery and judged to clinically require ischemia evaluation will be included in this study. Receives: Device: iFR / FFR measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
FFRct before TAVR
Measured: Baseline
Secondary outcomes (4)
FFRct after TAVR
Measured: Up to 4 weeks
FFR after TAVR
Measured: Up to 4 weeks
iFR before TAVR and after TAVR
Measured: Baseline and up to 4 weeks
Stenosis degree in coronary angiography performed before TAVR
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start13 Sep 2018 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kobe University
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Hiromasa Otake, Kobe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665389
- Sponsor's protocol ID
- 300028
- Acronym
- FORTUNA
- Status last verified
- Sep 2018
- First submitted
- 30 Aug 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing Transcatheter Aortic Valve Replacement（FORTUNA）: Single Center, Open-label, Exploratory, Prospective Study
- ClinicalTrials.gov ID
- NCT03665389
- Acronym / sponsor ID
- FORTUNA / 300028
- Conditions
- Aortic Valve Stenosis, Coronary Artery Disease
- Keywords
- FFRct, aortic stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Kobe UniversityIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2018 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 11 Sep 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 objective of this study is to evaluate the relationship between fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRct) before transcatheter aortic valve replacement (TAVR) and FFR after TAVR so as to investigate whether FFRct is useful for evaluating myocardial ischemia of severe AS. Furthermore, by measuring the instantaneous wave-free ratio (iFR) which is a physiological diagnostic method of coronary artery stenosis before and after TAVR and comparing iFR (iFR before and after TAVR) and FFR (FFR after TAVR) with FFRct (FFRct before and after TAVR), It also aims to deepen understanding of resting coronary artery physiology in aortic valve stenosis.
Detailed description
This is a single-center, open-label, exploratory, prospective study. Among patients who undergo coronary computed tomography angiography (cCTA) prior to TAVR, those with moderate or severe stenotic lesions will be included in the study. Patients from whom consent is obtained following TAVR will be enrolled in the study.
Among patients who undergo TAVR at the Kobe University Hospital from September 2018 to March 2022, those who are found to have moderate or severe stenosis on cCTA performed before surgery and judged to clinically require ischemia evaluation will be included in the study. At the time of pre-TAVR coronary angiogram, iFR (iFR before TAVR) will be measured. The cCTA data collected from patients whose consent is obtained following TAVR will be anonymized and sent to HeartFlow, Inc., where the FFRct（FFRct before TAVR) values will be calculated using their cardiovascular dynamics analysis program. FFR (FFR after TAVR) and iFR (iFR after TAVR) will be measured using a guide wire that is capable of sensing pressure after TAVR is performed. Furthermore, FFRct (FFRct after TAVR) is calculated from cCTA taken after TAVR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: iFR / FFR measurementAmong patients who undergo TAVR at the kobe university hospital, those who are found to have moderate or severe stenosis on cCTA performed before surgery and judged to clinically require ischemia evaluation will be included in this study. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Among patients who have undergone cCTA prior to TAVR, those with moderate stenotic lesions (30 to <70%) or severe stenotic lesions on CT who are candidates for percutaneous coronary intervention (PCI) following TAVR
- Patients aged 20 years or older at the time of diagnosis
Key exclusion criteria (10 listed)
- Patients who were implanted with metal stents in the left main trunk,
- Patients with stenosis of >30% in the left main trunk who were implanted with at least one metal stent in the vessel(s) of the left coronary circulation,
- Patients who were implanted with metal stents in at least 2 vessels of the coronary circulation,
- Patients who requested withdrawal of consent for participation in this research study after providing their consent,
- Patients who underwent coronary artery bypass surgery,
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 |
|---|---|---|
| iFR / FFR measurementAt the time of pre-TAVR coronary angiogram, iFR (iFR before TAVR) will be measured. The cCTA data collected from patients whose consent is obtained following TAVR will be anonymized and sent to HeartFlow, Inc., where the FFRct （FFRct before TAVR） values will be calculated using their cardiovascular dynamics analysis program. With the FFRct values blinded, FFR (FFR after TAVR) and iFR (iFR after TAVR) will be measured using a guide wire that is capable of sensing pressure after TAVR is performed. Furthermore, FFRct(FFRct after TAVR) is calculated from cCTA taken after TAVR. | Device | Single Arm |
Primary outcome
FFRct before TAVR
Time frame: Baseline
4 secondary outcomes
FFRct after TAVR
Time frame: Up to 4 weeks
FFR after TAVR
Time frame: Up to 4 weeks
iFR before TAVR and after TAVR
Time frame: Baseline and up to 4 weeks
Stenosis degree in coronary angiography performed before TAVR
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing iFR / FFR measurement in people with Aortic Valve Stenosis and Coronary Artery Disease, run by Kobe University.
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 2 inclusion and 10 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 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
FFRct before TAVR (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2018.