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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
| Cardiovascular Research Foundation, New York | OTHER |
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This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post angiographically successful PCI (Percutaneous Coronary Intervention).
DEFINE-PCI is a multi-center, prospective, non-significant risk study in up to 25 centers in USA and internationally. Consented subjects with CAD (Coronary Artery Disease) who undergo physiologic lesion assessment with iFR<0.90 in at least 1 coronary artery are eligible for participation. After successful PCI to all culprit lesions based on angiographic assessment of the treating physician, a blinded post-PCI iFR and iFR pullback will be performed. The proportion of patients with impaired post-PCI iFR will be assessed, and the number of patients in whom ischemia could theoretically be normalized with further PCI determined. Additionally, the association between the post-PCI iFR results and cardiovascular events and clinical symptoms will be assessed. Follow-up will be at 1, 6 and 12 months, including administration of quality of life questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iFR post angiographically successful PCI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iFR pullback | Diagnostic Test | iFR pullback assessment post angiographically successful PCI |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Residual Ischemia (iFR <0.90) | Residual ischemia is defined as iFR measurement <0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis <50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR<0.90) after a PCI that appeared to be successful based on angiography. | end of procedure/intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Events | Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization or recurrent ischemia at one year after PCI | 12 months |
| Target Vessel Failure |
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Inclusion Criteria:
Exclusion Criteria:
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Consented subjects with CAD who undergo physiologic lesion assessment with iFR<0.90 in at least 1 coronary artery are eligible for participation
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| Name | Affiliation | Role |
|---|---|---|
| Becky Inderbitzen, MSE | Philips (Volcano) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center | Long Beach | California | 90822 | United States | ||
| Colorado Heart and Vascular |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31648761 | Result | Jeremias A, Davies JE, Maehara A, Matsumura M, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp A, Ali ZA, Mintz G, Patel M, Stone GW. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study. JACC Cardiovasc Interv. 2019 Oct 28;12(20):1991-2001. doi: 10.1016/j.jcin.2019.05.054. | |
| 34991824 |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI | all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2017 |
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Target vessel failure defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization
| 12 months |
| Quality of Life Change From Baseline to 12 Months Follow-up | Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1 year (12 months). Minimum score is 0 and maximum score is 100, with a high score representing a more positive quality of life score. Outcome is the change in score from baseline to 12 months follow-up. | 12 months |
| Cardiac Mortality | All-cause and cardiac mortality at one year | 12 months |
| Target Vessel MI | Target vessel Myocardial infarction at one year | 12 month |
| Target Vessel Revascularization | Ischemia-driven target vessel revascularization at one year | 12 month |
| Recurrent Ischemia | Recurrent ischemia at one-year | 12 month |
| Correlation Between iFR and Angiographic Visual Interpretation | Correlation between iFR <0.90 and coronary stenosis >50% assessed by visual interpretation. This was tested using generalized estimating equations for logistic regression to account for the correlation of observations from the same subject. An absolute value of exactly 1 implies that a linear equation describes the relationship between iFR and visual interpretation of the angiography. Outcome reports how well the iFR value and the visual interpretation are in agreement (for example, when iFR <0.90 and coronary stenosis >50% assessed by visual interpretation the correlation is 1). | at the end of the procedure/intervention |
| Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI | Number of participants in which the iFR would become non-significant if a focal stenosis demonstrated by iFR pullback were treated with PCI | Procedural |
| Differentiation | Differentiation of the cause for impaired iFR | End of procedure /intervention |
| Delta iFR | Predictors of delta iFR before and after PCI, or predictors of impaired iFR Outcome is presented as the odds ratio (OR) that the post-PCI iFR will be <0.90. An OR > 1 means greater odds that the post-PCI iFR is <0.90, OR = 1 means there is no association, and OR < 1 means there is a lower odds that the post-PCI iFR is <0.90. | at the end of the procedure/intervention |
| Lakewood |
| Colorado |
| 80204 |
| United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Rockford CV Associates | Rockford | Illinois | 61107 | United States |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | United States |
| Dartmouth Hitchcock | Lebanon | New Hampshire | 03756 | United States |
| South Side Hospital | Bay Shore | New York | 11706 | United States |
| Northshore Hospital | Manhasset | New York | 11030 | United States |
| Columbia University Medical Center/NewYork Presbyterian Hospital | New York | New York | 10032 | United States |
| New York Presbyterian Hospital -Weill Cornell | New York | New York | 10065 | United States |
| Lenox Hill Hospital | New York | New York | 10075 | United States |
| St Francis Hospital | Roslyn | New York | 11576 | United States |
| SUNY- Stony Brook | Stony Brook | New York | 11794 | United States |
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| Vidant Medical Center | Greenville | North Carolina | 27835 | United States |
| Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Wellmont CVA Heart Insitute | Kingsport | Tennessee | 37660 | United States |
| VA North Texas Health Care | Dallas | Texas | 75216 | United States |
| Aurora St Lukes Medical Center | Milwaukee | Wisconsin | 53215 | United States |
| AMC Amsterdam | Amsterdam | Netherlands |
| VU University Medical Center | Amsterdam | Netherlands |
| Basildon Univeristy Hospital | Basildon | SS165NL | United Kingdom |
| Royal Bournemouth hospital | Bournemouth | BH7 7DW | United Kingdom |
| Royal Devon & Exeter NHS Foundation Trust | Exeter | EX25DW | United Kingdom |
| Imperial College of London- Hammersmith Hospital | London | W12OHS | United Kingdom |
| Derived |
| Patel MR, Jeremias A, Maehara A, Matsumura M, Zhang Z, Schneider J, Tang K, Talwar S, Marques K, Shammas NW, Gruberg L, Seto A, Samady H, Sharp ASP, Ali ZA, Mintz G, Davies J, Stone GW. 1-Year Outcomes of Blinded Physiological Assessment of Residual Ischemia After Successful PCI: DEFINE PCI Trial. JACC Cardiovasc Interv. 2022 Jan 10;15(1):52-61. doi: 10.1016/j.jcin.2021.09.042. |
| Analyzable iFR Pullback Assessment Post Angiographically Successful PCI |
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| COMPLETED | completed means study follow-up at 1 year completed |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic Test: iFR Pullback | iFR (instantaneous wave free ratio) pullback assessment post angiographically successful PCI |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| BMI (Body Mass Index) | Mean | Standard Deviation | kg/m^2 |
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| Smoker | Count of Participants | Participants |
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| Diabetes Mellitus | Count of Participants | Participants |
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| Insulin treated diabetes | Count of Participants | Participants |
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| Hyperlipidemia | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Renal disease | Count of Participants | Participants |
| ||||||||||||||||||
| Prior Percutaneous Coronary Intervention (PCI) | Count of Participants | Participants |
| ||||||||||||||||||
| Prior Myocardial Infarction | Count of Participants | Participants |
| ||||||||||||||||||
| Left ventricular ejection fraction (%) | Mean | Standard Deviation | % of blood ejected with each contraction |
| |||||||||||||||||
| Stable angina | Count of Participants | Participants |
| ||||||||||||||||||
| Unstable Angina | Count of Participants | Participants |
| ||||||||||||||||||
| NSTEMI (Non-ST Elevated Myocardial Infarction) | Count of Participants | Participants |
| ||||||||||||||||||
| Silent Ischemia | Count of Participants | Participants |
| ||||||||||||||||||
| Recent STEMI (ST Elevated MI) (>7days) | Count of Participants | Participants |
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| 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 | Number of Participants With Residual Ischemia (iFR <0.90) | Residual ischemia is defined as iFR measurement <0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis <50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR<0.90) after a PCI that appeared to be successful based on angiography. | Total vessels/units (535) in participant population (467) | Posted | Number | participants | end of procedure/intervention | Number of vessels in 467 participants | Number of vessels in 467 participants |
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| Secondary | Cardiac Events | Composite endpoint of cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization or recurrent ischemia at one year after PCI | The total number of participants was divided in two groups based on their post-PCI iFR result. (see primary endpoint) The total number of participants still in study at one year is 467. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Target Vessel Failure | Target vessel failure defined as cardiac death, target vessel myocardial infarction, ischemia-driven target vessel revascularization | The total number of participants was divided in two groups based on their post-PCI iFR result. (see primary endpoint) The total number of participants still in study at one year is 467. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Quality of Life Change From Baseline to 12 Months Follow-up | Quality of life (assessed by the Seattle Angina Questionnaire) at baseline, 30-days, 6 months and 1 year (12 months). Minimum score is 0 and maximum score is 100, with a high score representing a more positive quality of life score. Outcome is the change in score from baseline to 12 months follow-up. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| Secondary | Cardiac Mortality | All-cause and cardiac mortality at one year | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Target Vessel MI | Target vessel Myocardial infarction at one year | Posted | Count of Participants | Participants | 12 month |
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| Secondary | Target Vessel Revascularization | Ischemia-driven target vessel revascularization at one year | Posted | Count of Participants | Participants | 12 month |
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| Secondary | Recurrent Ischemia | Recurrent ischemia at one-year | Posted | Count of Participants | Participants | 12 month |
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| Secondary | Correlation Between iFR and Angiographic Visual Interpretation | Correlation between iFR <0.90 and coronary stenosis >50% assessed by visual interpretation. This was tested using generalized estimating equations for logistic regression to account for the correlation of observations from the same subject. An absolute value of exactly 1 implies that a linear equation describes the relationship between iFR and visual interpretation of the angiography. Outcome reports how well the iFR value and the visual interpretation are in agreement (for example, when iFR <0.90 and coronary stenosis >50% assessed by visual interpretation the correlation is 1). | The correlation calculation was performed on the total number of analyzable participants with a post-PCI iFR pullback assessment. | Posted | Number | coefficient of determination (R2) | at the end of the procedure/intervention |
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| Secondary | Number of Participants in Which the iFR Would Become Non-significant if a Focal Stenosis Demonstrated by iFR Pullback Were Treated With PCI | Number of participants in which the iFR would become non-significant if a focal stenosis demonstrated by iFR pullback were treated with PCI | This analysis assumes that all focal lesions with post-PCI iFR <0.90 were successfully treated with additional PCI. Using the cutoff of iFR <0.90, the outcome is the number of participants that would remain, or not have been treated, because the iFR measurements are under 0.90. | Posted | Count of Participants | Participants | Procedural |
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| Secondary | Differentiation | Differentiation of the cause for impaired iFR | Number of vessels in which residual ischemia (post-PCI iFR <0.90) after angiographically successful PCI | Posted | Number | vessels | End of procedure /intervention | vessels | vessels |
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| Secondary | Delta iFR | Predictors of delta iFR before and after PCI, or predictors of impaired iFR Outcome is presented as the odds ratio (OR) that the post-PCI iFR will be <0.90. An OR > 1 means greater odds that the post-PCI iFR is <0.90, OR = 1 means there is no association, and OR < 1 means there is a lower odds that the post-PCI iFR is <0.90. | Posted | Number | Odds ratio | at the end of the procedure/intervention |
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Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects were collected and if any occurred, they would likely occur during the procedure when the device is being used. Subjects were followed for 12 months and all complaints promptly reported.
As noted above, the only reportable events were Adverse Device Effects, Serious Adverse Device Effects, and Unanticipated Adverse Device Effects.
Subjects were followed for 12 months, with follow-up visits at 1, 6, and 12 months.
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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 | All Participants With Analyzable iFR Pullback Assessment Post Angiographically Successful PCI | all participants in the study with analyzable iFR pullback assessment that was performed after a successful PCI, where a successful PCI is assessed based on angiographic results. | 0 | 467 | 12 | 467 | 0 | 467 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Target Vessel Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Ischemia-driven Target Vessel Revascularization | Cardiac disorders | Systematic Assessment |
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| Recurrent Ischemia | Cardiac disorders | Systematic Assessment |
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| Cardiac Death | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Becky Inderbitzen, Global Director, Clinical Development | Philips (Volcano) | +1.858.764.1336 | becky.inderbitzen@philips.com |
| Jun 29, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D023921 | Coronary Stenosis |
| D000789 | Angina, Unstable |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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