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| Name | Class |
|---|---|
| Baim Institute for Clinical Research | OTHER |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | OTHER |
| Minneapolis Heart Institute Foundation | OTHER |
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This is a prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard.
285 patient, prospective, multi-center trial conducted at up to 20 US, Canadian, European and Asian centers designed to determine the diagnostic performance of CT-FLOW (the investigational technology) by coronary computed tomographic angiography (CCTA) for non-invasive assessment of the hemodynamic significance of coronary lesions, as compared to direct measurement of fractional flow reserve (FFR) during cardiac catheterization as a reference standard
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Other | Patients will receive cCTA, ICA, FFR, and cFFR per protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR | Device | Fractional flow reserve measured during cardiac catheterization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone | Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis* at the subject level using binary outcomes when compared to invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values ≤0.80 considered diseased; values >0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses ≥50% considered obstructive and <50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Performance of CCTA Plus FFRCT at the Subject Level | Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CCTA plus CT-FLOW at the subject level using binary outcomes when compared to FFR as the reference standard. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James K Min, MD, FACC | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spring Hill Hospital | Mobile | Alabama | 36608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21930103 | Background | Min JK, Berman DS, Budoff MJ, Jaffer FA, Leipsic J, Leon MB, Mancini GB, Mauri L, Schwartz RS, Shaw LJ. Rationale and design of the DeFACTO (Determination of Fractional Flow Reserve by Anatomic Computed Tomographic AngiOgraphy) study. J Cardiovasc Comput Tomogr. 2011 Sep-Oct;5(5):301-9. doi: 10.1016/j.jcct.2011.08.003. Epub 2011 Aug 7. | |
| 22922562 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm Study | Patients will receive cCTA, ICA, FFR, and cFFR per protocol. FFR: Fractional flow reserve measured during cardiac catheterization |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm Study | Patients will receive cCTA, ICA, FFR, and cFFR per protocol. FFR: Fractional flow reserve measured during cardiac catheterization |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Diagnostic Accuracy of CCTA Plus FFRCT and CCTA Alone | Diagnostic accuracy of CCTA (Cardiac Computed Tomography Angiography) plus FFRCT (Noninvasive Fractional Flow Reserve computed from CCTA) to determine presence or absence of at least one hemodynamically (HD)-significant coronary artery stenosis* at the subject level using binary outcomes when compared to invasive FFR (Fractional Flow Reserve) as the reference standard. In the per-patient analysis, vessels with the most adverse clinical status were selected to represent a given patient. FFR and FFRCT measurements were recorded on a continuous scale and dichotomized at the 0.80 threshold (values ≤0.80 considered diseased; values >0.80 nondiagnostic for ischemia). Stenosis on CCTA was recorded at the 50% threshold (stenoses ≥50% considered obstructive and <50% as non-significant). Prespecified primary endpoint was expected to be greater than 70% of the lower bound of the 95% confidence interval. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 day |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm Study | Patients will receive cCTA, ICA, FFR, and cFFR per protocol. FFR: Fractional flow reserve measured during cardiac catheterization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retroperitoneal bleed | Vascular disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Whitney Huey | Heartflow, Inc. | 650.257.6697 | whuey@heartflow.com |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Min JK, Leipsic J, Pencina MJ, Berman DS, Koo BK, van Mieghem C, Erglis A, Lin FY, Dunning AM, Apruzzese P, Budoff MJ, Cole JH, Jaffer FA, Leon MB, Malpeso J, Mancini GB, Park SJ, Schwartz RS, Shaw LJ, Mauri L. Diagnostic accuracy of fractional flow reserve from anatomic CT angiography. JAMA. 2012 Sep 26;308(12):1237-45. doi: 10.1001/2012.jama.11274. |
| 25592691 | Derived | Park HB, Heo R, O Hartaigh B, Cho I, Gransar H, Nakazato R, Leipsic J, Mancini GBJ, Koo BK, Otake H, Budoff MJ, Berman DS, Erglis A, Chang HJ, Min JK. Atherosclerotic plaque characteristics by CT angiography identify coronary lesions that cause ischemia: a direct comparison to fractional flow reserve. JACC Cardiovasc Imaging. 2015 Jan;8(1):1-10. doi: 10.1016/j.jcmg.2014.11.002. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Single Arm Study |
Per-patient performance (diagnostic accuracy) CCTA plus FFRCT |
|
|
| Secondary | Diagnostic Performance of CCTA Plus FFRCT at the Subject Level | Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CCTA plus CT-FLOW at the subject level using binary outcomes when compared to FFR as the reference standard. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 day |
|
|
|
| 2 |
| 252 |
| 0 |
| 252 |
| Hypotension | Vascular disorders |
|
| Septic shock | Blood and lymphatic system disorders |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| Title | Measurements |
|---|---|
|
| Negative predictive value |
|