Coronary Artery StenosisCHOICE-FRNCT05133843
Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
A study testing Assession of complete coronary physiology in people with Coronary Artery Stenosis and Transcatheter Aortic Valve Implantation, run by Helios Health Institute GmbH at 1 site in Germany.
Trial summary
The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis, Transcatheter Aortic Valve Implantation
- What is being tested?
- Assession of complete coronary physiology
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 29 Sep 2021to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- Severe symptomatic aortic stenosis with indication for TAVI according to current guidelines deemed by the Heart Team
- Patients who have undergone coronary CT angiography before TAVI in which CAD could not be ruled out
- CAD in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed coronary stenosis, in which the physiological severity of the lesion is in question (typically 40-90% diameter stenosis).
- Eligible for invasive coronary angiography and functional assessment (FFR, RFR, CFR and IMR)
- Eligible for coronary CT-angiography and functional assessment (CT-FFR)
Who cannot join
- Patients whose CT-angiography was determined to be non-diagnostic/unreadable during its evaluation
- Previous coronary artery bypass grafting with patent grafts to the interrogated vessel
- Patients with severe lesions with a diameter stenosis ≥ 90%, flow-limiting lesions, or a significant left main coronary artery stenosis
- Critical coronary artery disease deemed by the Heart Team to require immediate revascularization
- Contraindication to adenosine (e.g. bronchial asthma)
- Chronic renal impairment with severe reduction of glomerular filtration rate (eGFR <30 ml/min)
- Presence of cardiogenic shock
- Participation in another interventional study involving the left heart or coronary arteries
Trial locations and contacts
1 site in 1 country.
Mohamed Abdel-Wahab, Prof. Dr. contact
Germany1 site, 1 recruiting
- Recruiting
Heart Center Leipzig at University of Leipzig Department of Internal Medicine/Cardiology
Leipzig, 04289
Nicolas Majunke, Dr., +49 341 865 1428, nicolas.majunke@medizin.uni-leipzig.de
Mohamed Abdel-Wahab, Prof. Dr.
About this study
The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. This aims to determine how TAVI affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence FFR and RFR values. In addition, it is aimed to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.
Read the detailed description
Prospective, single center, open-label study to
- compare coronary flow reserve (CFR), index of microvascular resistance (IMR), fractional flow reserve (FFR) and resting full cycle ratio (RFR) values before TAVI and 6 months after TAVI
- correlate testing of microcirculatory function (IMR) with measurements of functional testing (FFR and RFR) before and six months after TAVI
- correlate functional testing (FFR and RFR) with computed tomography (CT) derived fractional flow reserve (CT-FFR) before and six months after TAVI.
- Being tested
- Assession of complete coronary physiology
- Keywords
- Coronary Artery Stenosis, transcatheter aortic valve implantation, coronary physiology, coronary blood flow, coronary microcirculatory function, non-invasive CT-FFR, fractional flow reserve, resting full cycle ratio
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assession of complete coronary physiologyProcedure or surgery
Also called FFR, RFR, CFR, IMR, and CT-FFR
Assession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI.
| Study group | Role | What they receive |
|---|---|---|
| Coronary physiology | Other | Assession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. Receives: Procedure: Assession of complete coronary physiology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI
Comparison of coronary flow reserve, index of microvascular resistance, fractional flow reserve and resting full cycle ratio.
The variation in correlation between CT-FFR and IMR, FFR or RFR before and after TAVI will be estimated using a General Linear Model (GLM) with an interaction between the independent variable (IMR, FFR, RFR) and the time period (before or after TAVI).
Measured: 6 Months
Secondary outcomes (2)
Diagnostic accuracy by considering FFR values of >0.80 as normal
diagnostic accuracy (sensitivity, specificity, positive predictive value [PPV] and negative predictive value [NPV]) of CT-FFR for the detection of significant coronary stenosis before and 6 months after TAVI by considering FFR values of >0.80 as normal
Measured: 6 Months
Diagnostic accuracy by considering RFR values of >0.89 as normal
diagnostic accuracy (sensitivity, specificity, positive predictive value [PPV] and negative predictive value [NPV]) of CT-FFR for the detection of significant coronary stenosis before and 6 months after TAVI by considering RFR values of >0.89 as normal
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start29 Sep 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery 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
- Model description
- Prospective, single center, open-label
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios Health Institute GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital
- Responsible party
- Sponsor
- Investigators
- Nicolas Majunke, Dr., Study chair, Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/CardiologyRobin Gohmann, Dr., Principal investigator, Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/CardiologyMohamed Abdel-Wahab, Prof. Dr., Principal investigator, Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133843
- Sponsor's protocol ID
- 2021-0125
- Acronym
- CHOICE-FR
- Status last verified
- Sep 2024
- First submitted
- 12 Nov 2021
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complete Functional Assessment of Intermediate Coronary Artery Stenosis Before and After Transcatheter Aortic Valve Implantation (TAVI) in Patients With Severe Symptomatic Aortic Valve Stenosis
- ClinicalTrials.gov ID
- NCT05133843
- Acronym / sponsor ID
- CHOICE-FR / 2021-0125
- Keywords
- Coronary Artery Stenosis, transcatheter aortic valve implantation, coronary physiology, coronary blood flow, coronary microcirculatory function, non-invasive CT-FFR, fractional flow reserve, resting full cycle ratio
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Helios Health Institute GmbHUniversity, hospital or other
- Collaborators
- Heart Center Leipzig - University Hospital
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 24 Nov 2021 (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 purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. This aims to determine how TAVI affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence FFR and RFR values. In addition, it is aimed to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.
Detailed description
Prospective, single center, open-label study to
- compare coronary flow reserve (CFR), index of microvascular resistance (IMR), fractional flow reserve (FFR) and resting full cycle ratio (RFR) values before TAVI and 6 months after TAVI
- correlate testing of microcirculatory function (IMR) with measurements of functional testing (FFR and RFR) before and six months after TAVI
- correlate functional testing (FFR and RFR) with computed tomography (CT) derived fractional flow reserve (CT-FFR) before and six months after TAVI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single center, open-label
| Arm | Type | Receives |
|---|---|---|
| Coronary physiology | Other | Procedure: Assession of complete coronary physiologyAssession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >18 years
- Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
- Severe symptomatic aortic stenosis with indication for TAVI according to current guidelines deemed by the Heart Team
- Patients who have undergone coronary CT angiography before TAVI in which CAD could not be ruled out
- CAD in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed coronary stenosis, in which the physiological severity of the lesion is in question (typically 40-90% diameter stenosis).
Key exclusion criteria (8 listed)
- Patients whose CT-angiography was determined to be non-diagnostic/unreadable during its evaluation
- Previous coronary artery bypass grafting with patent grafts to the interrogated vessel
- Patients with severe lesions with a diameter stenosis ≥ 90%, flow-limiting lesions, or a significant left main coronary artery stenosis
- Critical coronary artery disease deemed by the Heart Team to require immediate revascularization
- Contraindication to adenosine (e.g. bronchial asthma)
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 |
|---|---|---|
| Assession of complete coronary physiologyAlso: FFR, RFR, CFR, IMR, and CT-FFRAssession of complete coronary physiology in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. | Procedure or surgery | Coronary physiology |
Primary outcome
Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI
Time frame: 6 Months
Comparison of coronary flow reserve, index of microvascular resistance, fractional flow reserve and resting full cycle ratio. The variation in correlation between CT-FFR and IMR, FFR or RFR before and after TAVI will be estimated using a General Linear Model (GLM) with an interaction between the independent variable (IMR, FFR, RFR) and the time period (before or after TAVI).
2 secondary outcomes
Diagnostic accuracy by considering FFR values of >0.80 as normal
Time frame: 6 Months
Diagnostic accuracy by considering RFR values of >0.89 as normal
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
Related trials for Coronary Artery Stenosis
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
Recruiting
Effects of Percutaneous Transluminal Renal Angioplasty of Atherosclerotic Renal Artery Stenosis in High-Risk Patients.
Renovascular Hypertension, Renovascular Hypertension With Renal Failure
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.
Mohamed Abdel-Wahab, Prof. Dr. contact
Nicolas Majunke, Dr. study chair
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Robin Gohmann, Dr. principal investigator
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Mohamed Abdel-Wahab, Prof. Dr. principal investigator
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assession of complete coronary physiology in people with Coronary Artery Stenosis and Transcatheter Aortic Valve Implantation, run by Helios Health Institute GmbH at 1 site in Germany.
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 7 inclusion and 8 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 25 Nov 2024. 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 Germany. 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?
Contact Nicolas Majunke, Dr. (+49 341 865 1428, nicolas.majunke@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of CFR, IMR, FFR and RFR values before TAVI and 6 months after TAVI (time frame: 6 Months). 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 25 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.