Coronary Artery DiseaseADAPTNCT04828590
The ADAPT Study: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Keya Medical at 10 sites in 5 countries.
Trial summary
DEEPVESSEL FFR is a medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography-derived fraction flow reserve (FFR) values from coronary CT angiogram images. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia
- How many people
- 302 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 10 Aug 2020to 31 Dec 2021
- Phase
- Observational
- 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
Study population: Patients with suspected CAD containing at least one 30%-90% coronary CTA stenosis.
Who may be able to join
- Patients' age ≥18 years;
- Has coronary CTA images acquired by ≥64 multidetector row CT scanner, no earlier than 2016 and within 60 days of the ICA-FFR procedure;
- Coronary CTA image shows at least one vessel segment (≥2mm diameter) with a diameter stenosis of 30%-90%;
Who cannot join
- Patients with any of the following conditions at the time of CTA imaging:
- Acute myocardial infarction;
- Unstable angina;
- Pulmonary edema;
- Heart function classification level III and IV (NYHA heart function classification);
- Implantable cardioverter defibrillator (ICD);
Show all 13Show fewer
- Prior percutaneous coronary intervention (PCI) or pacemaker surgery;
- Prior coronary artery bypass grafting (CABG) surgery;
- Prior heart valve replacement;
- Prior history of complex congenital heart disease;
- Prior history of cardiomyopathy;
- BMI >35;
- Coronary total occlusion.
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
United States5 sites
Medical University of South Carolina
Charleston, South Carolina, 29407
Holy Cross Health
Fort Lauderdale, Florida, 33308
University of Kansas Medical Center
Kansas City, Kansas, 66160
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease
DEEPVESSEL FFR is a medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography-derived fraction flow reserve (FFR) values from coronary CT angiogram images. The primary objective of this multi-center clinical validation study is to validate the clinical performance of DEEPVESSEL FFR in identifying patients with myocardial ischemia due to significant obstructive coronary artery diseases.
Read the detailed description
Coronary artery disease (CAD) is the most common type of heart disease, and it is the leading cause of death worldwide in both men and women. CAD happens when the coronary arteries become hardened and narrowed, which is due to the buildup of cholesterol-containing deposits-plaque on the inner vessel wall. As the plaque grows, less blood can flow through the arteries due to the vessel narrowing. Decreased blood flow can then lead to chest pain (angina), shortness of breath, or even a heart attack.
Fractional flow reserve (FFR), a measure of blood flow reduction caused by vessel narrowing, is accepted as gold standard for assessing the functional significance of stenotic lesions. Multiple randomized trials have demonstrated that FFR has excellent diagnostic value in identifying functionally significant lesions and guiding coronary revascularization procedures. However, FFR is measured invasively through a pressure wire-based cardiac catheter procedure in the catheterization lab. Current guidelines recommend assessing myocardial ischemia of stable patients with CAD through non-invasive functional testing before considering invasive coronary angiography (ICA) or conducting myocardial revascularization.
DEEPVESSEL FFR (DVFFR) is a software medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography -derived FFR values from coronary CT angiogram (CTA) images. It uses deep learning neural networks that encode imaging, structural, and functional characteristics of coronary arteries and learn complex mapping between FFR values and the encoded information. The quantitative FFR analysis based on the coronary CTA images can help clinicians assess the physiological function in patients with CAD non-invasively.
The primary objective of this study is to evaluate the diagnostic performance of DVFFR software in identifying patients with significant obstructive CAD causing myocardial ischemia, using invasively measured ICA FFR as the reference standard.
- Conditions
- Coronary Artery Disease, Myocardial Ischemia
- Being tested
- No intervention
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Due to observational study
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected CAD containing at least one 30%-90% coronary CTA stenosis | Patients' datasets with suspected CAD containing at least one 30%-90% coronary CTA stenosis; and ICA-FFR was measured on vessels with diameters greater than 2 mm will be analyzed. Diagnostic performance based on CT-derived FFR using DVFFR software will be compared with the diagnostic performance from ICA-FFR measurements. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of DVFFR at the vessel level in identifying ischemic lesions, i.e. DVFFR value≤0.80, from coronary CTA images, using ICA-FFR measurement as a reference standard.
On the vessel level, if a vessel with at least one stenosis lesion with a FFR measurement less or equal to 0.80, this vessel is considered to be ischemic. A true positive on the vessel level is defined as a vessel containing at least one stenosis with DVFFR value ≤0.80 and its corresponding reference ICA-FFR value is also ≤0.80.
Measured: through study completion, an average of 1 year
Specificity of DVFFR at the vessel level in identifying ischemic lesions, i.e. DVFFR value≤0.80, from coronary CTA images, using ICA-FFR measurement as a reference standard.
On the vessel level, if a vessel with at least one stenosis lesion with a FFR measurement less or equal to 0.80, this vessel is considered to be ischemic. A true positive on the vessel level is defined as a vessel containing at least one stenosis with DVFFR value ≤0.80 and its corresponding reference ICA-FFR value is also ≤0.80.
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Diagnostic accuracy, positive predictive value (PPV) and negative predictive value (NPV) of DVFFR at the vessel level
On the vessel lever, if a vessel with at least one stenosis lesion with a FFR measurement less or equal to 0.80, this vessel is considered to be ischemic. A true positive on the vessel level is defined as a vessel containing at least one stenosis with DVFFR value ≤0.80 and its corresponding reference ICA-FFR value is also ≤0.80.
Measured: through study completion, an average of 1 year
Diagnostic performance including sensitivity, specificity, accuracy, PPV and NPV of DVFFR at the patient level
At the patient level, if a patient has at least one vessel that has been identified as causing ischemia, this patient is considered a patient positive for ischemia. A true positive on the patient level is defined as when a patient has at least one lesion with a DVFFR value ≤0.80 and its corresponding reference ICA-FFR is also ≤0.80.
Measured: through study completion, an average of 1 year
Per-vessel Pearson correlation coefficient between DVFFR and ICA-FFR values
Correlation between CT-derived DVFFR values and wire-measured ICA-FFR values will be evaluated at the vessel level.
Measured: through study completion, an average of 1 year
Diagnostic performance (including sensitivity, specificity, accuracy, PPV and NPV) in detecting hemodynamically significant coronary obstruction using DVFFR and coronary CTA alone, on both vessel level and patient level.
For coronary CTA, hemodynamically significant obstruction of a coronary artery is defined as a stenosis ≥50%. The per-patient stenosis degree will be specified as the most severe stenosis among the major epicardial artery vessels presented in coronary CTA.
Measured: through study completion, an average of 1 year
Stratified analyses on different subgroups of subjects' data
Stratified analyses on different subgroups of subjects' data, ranging from patient demographics and disease conditions.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start10 Aug 2020
- Primary completion1 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keya Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Joseph Schoepf, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828590
- Sponsor's protocol ID
- DVFFR ADAPT Study
- Acronym
- ADAPT
- Status last verified
- Apr 2022
- First submitted
- 28 Mar 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the DiAgnostic Performance of DeepVessel FFR in SuspecTed Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04828590
- Acronym / sponsor ID
- ADAPT / DVFFR ADAPT Study
- Conditions
- Coronary Artery Disease, Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Keya MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 2 Apr 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.
DEEPVESSEL FFR is a medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography-derived fraction flow reserve (FFR) values from coronary CT angiogram images. The primary objective of this multi-center clinical validation study is to validate the clinical performance of DEEPVESSEL FFR in identifying patients with myocardial ischemia due to significant obstructive coronary artery diseases.
Detailed description
Coronary artery disease (CAD) is the most common type of heart disease, and it is the leading cause of death worldwide in both men and women. CAD happens when the coronary arteries become hardened and narrowed, which is due to the buildup of cholesterol-containing deposits-plaque on the inner vessel wall. As the plaque grows, less blood can flow through the arteries due to the vessel narrowing. Decreased blood flow can then lead to chest pain (angina), shortness of breath, or even a heart attack.
Fractional flow reserve (FFR), a measure of blood flow reduction caused by vessel narrowing, is accepted as gold standard for assessing the functional significance of stenotic lesions. Multiple randomized trials have demonstrated that FFR has excellent diagnostic value in identifying functionally significant lesions and guiding coronary revascularization procedures. However, FFR is measured invasively through a pressure wire-based cardiac catheter procedure in the catheterization lab. Current guidelines recommend assessing myocardial ischemia of stable patients with CAD through non-invasive functional testing before considering invasive coronary angiography (ICA) or conducting myocardial revascularization.
DEEPVESSEL FFR (DVFFR) is a software medical device that is designed to extract three- dimensional coronary tree structures and generate computed tomography -derived FFR values from coronary CT angiogram (CTA) images. It uses deep learning neural networks that encode imaging, structural, and functional characteristics of coronary arteries and learn complex mapping between FFR values and the encoded information. The quantitative FFR analysis based on the coronary CTA images can help clinicians assess the physiological function in patients with CAD non-invasively.
The primary objective of this study is to evaluate the diagnostic performance of DVFFR software in identifying patients with significant obstructive CAD causing myocardial ischemia, using invasively measured ICA FFR as the reference standard.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected CAD containing at least one 30%-90% coronary CTA stenosis | – | Other: No interventionPatients' datasets with suspected CAD containing at least one 30%-90% coronary CTA stenosis; and ICA-FFR was measured on vessels with diameters greater than 2 mm will be analyzed. Diagnostic performance based on CT-derived FFR using DVFFR software will be compared with the diagnostic performance from ICA-FFR measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspected CAD containing at least one 30%-90% coronary CTA stenosis.
Key inclusion criteria (3 listed)
- Patients' age ≥18 years;
- Has coronary CTA images acquired by ≥64 multidetector row CT scanner, no earlier than 2016 and within 60 days of the ICA-FFR procedure;
- Coronary CTA image shows at least one vessel segment (≥2mm diameter) with a diameter stenosis of 30%-90%;
Key exclusion criteria (13 listed)
- Acute myocardial infarction;
- Unstable angina;
- Pulmonary edema;
- Heart function classification level III and IV (NYHA heart function classification);
- Implantable cardioverter defibrillator (ICD);
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 |
|---|---|---|
| No interventionDue to observational study | Other | Patients with suspected CAD containing at least one 30%-90% coronary CTA stenosis |
Primary outcome
Sensitivity of DVFFR at the vessel level in identifying ischemic lesions, i.e. DVFFR value≤0.80, from coronary CTA images, using ICA-FFR measurement as a reference standard.
Time frame: through study completion, an average of 1 year
On the vessel level, if a vessel with at least one stenosis lesion with a FFR measurement less or equal to 0.80, this vessel is considered to be ischemic. A true positive on the vessel level is defined as a vessel containing at least one stenosis with DVFFR value ≤0.80 and its corresponding reference ICA-FFR value is also ≤0.80.
Specificity of DVFFR at the vessel level in identifying ischemic lesions, i.e. DVFFR value≤0.80, from coronary CTA images, using ICA-FFR measurement as a reference standard.
Time frame: through study completion, an average of 1 year
On the vessel level, if a vessel with at least one stenosis lesion with a FFR measurement less or equal to 0.80, this vessel is considered to be ischemic. A true positive on the vessel level is defined as a vessel containing at least one stenosis with DVFFR value ≤0.80 and its corresponding reference ICA-FFR value is also ≤0.80.
5 secondary outcomes
Diagnostic accuracy, positive predictive value (PPV) and negative predictive value (NPV) of DVFFR at the vessel level
Time frame: through study completion, an average of 1 year
Diagnostic performance including sensitivity, specificity, accuracy, PPV and NPV of DVFFR at the patient level
Time frame: through study completion, an average of 1 year
Per-vessel Pearson correlation coefficient between DVFFR and ICA-FFR values
Time frame: through study completion, an average of 1 year
Diagnostic performance (including sensitivity, specificity, accuracy, PPV and NPV) in detecting hemodynamically significant coronary obstruction using DVFFR and coronary CTA alone, on both vessel level and patient level.
Time frame: through study completion, an average of 1 year
Stratified analyses on different subgroups of subjects' data
Time frame: through study completion, an average of 1 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 22 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
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
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Joseph Schoepf, MD principal investigator
Medical University of South Carolina
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Keya Medical at 10 sites in 5 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 13 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Italy, Austria, France, Poland. 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?
Sensitivity of DVFFR at the vessel level in identifying ischemic lesions, i.e. DVFFR value≤0.80, from coronary CTA images, using ICA-FFR measurement as a reference standard. (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 22 Apr 2022.