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| Name | Class |
|---|---|
| Acist Medical Systems | INDUSTRY |
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The purpose of this study is to compare FFR measurements done with adenosine to FFR measurements done with contrast, where the contrast is injected using the ACIST CVi automated contrast injector.
The ACCELERATION study will support a safer approach to FFR for patients by potentially reducing toxic drug exposure (adenosine). The 2 main objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aFFR vs cFFR | Other | All subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iopamidol | Drug | aFFR measurement with drug: Iopamidol (ISOVUE®-370). Subjects will receive an injector-based intracoronary bolus of contrast
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) | FFR is the ratio between the maximal myocardial flow measured in a diseased coronary artery and the theoretical maximal blood flow in the same territory in the absence of the stenosis, measured using adenosine induced hyperemia (aFFR) or contrast induced hyperemia (cFFR). Contrast FFR is being compared to the gold-standard adenosine FFR. An aFFR equal or less than 0.80 is the gold-standard cut-off to benefit from intervention. Reported as the percentage of agreement between aFFR and cFFR. | Baseline |
| Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves | The qualitative method comparison assesses the agreement as to which lesion is flow limiting. The contrast FFR measurement that corresponds to adenosine FFR measurement value of 0.8 will be used as the cutoff value for determining whether a lesion is flow limiting for contrast FFR. Reported as the percentage of agreement between aFFR and cFFR. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | (MACE: death, MI, and TVR) TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. An MI is caused by decreased or complete cessation of blood flow to a portion of the myocardium. | 30 days post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh Swaminathan, MD | DCRI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach VA | Long Beach | California | 90822 | United States | ||
| Mercy Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40270240 | Derived | Swaminathan RV, Marquis-Gravel G, Boivin-Proulx LA, Benjamin DK, Rikhi A, Raveendran G, Chambers JW, Seto AH, Bagai J, White R, Gutierrez JA, Povsic TJ, Rao SV, Krucoff MW. Adenosine Contrast Correlations in Evaluating Revascularization: The (ACCELERATION) Study. Circ Cardiovasc Interv. 2025 Jun;18(6):e015240. doi: 10.1161/CIRCINTERVENTIONS.125.015240. Epub 2025 Apr 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | aFFR and cFFR | All subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System Iopamidol: aFFR measurement with drug: Iopamidol (ISOVUE®-370). Subjects will receive an injector-based intracoronary bolus of contrast
adenosine: FFR measurement with drug: adenosine. Intravenous adenosine will be administered at a rate of 140 μg/kg of body weight per minute x 2 minutes Navvus® Catheter: the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing CVi® Contrast Delivery System: The CVi® Contrast Delivery System will be used to deliver the contrast medium |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| aFFR |
| |||||||||||||
| cFFR |
|
Baseline analyses include all participants who completed aFFR and cFFR measurements.
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| ID | Title | Description |
|---|---|---|
| BG000 | aFFR vs cFFR | All subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System Iopamidol: aFFR measurement with drug: Iopamidol (ISOVUE®-370). Subjects will receive an injector-based intracoronary bolus of contrast
adenosine: FFR measurement with drug: adenosine. Intravenous adenosine will be administered at a rate of 140 μg/kg of body weight per minute x 2 minutes Navvus® Catheter: the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing CVi® Contrast Delivery System: The CVi® Contrast Delivery System will be used to deliver the contrast medium |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) | FFR is the ratio between the maximal myocardial flow measured in a diseased coronary artery and the theoretical maximal blood flow in the same territory in the absence of the stenosis, measured using adenosine induced hyperemia (aFFR) or contrast induced hyperemia (cFFR). Contrast FFR is being compared to the gold-standard adenosine FFR. An aFFR equal or less than 0.80 is the gold-standard cut-off to benefit from intervention. Reported as the percentage of agreement between aFFR and cFFR. | All subjects received Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System. The FFR tracings of 217 lesions from 201 participants were assessed for quality and validity by the Fractional Flow Reserve Core Lab. After qualitative review, 192 FFR pairs were included in the analysis. | Posted | Number | 95% Confidence Interval | proportion of lesions with agreement | Baseline | lesions | lesions |
|
1 year post procedure
Adverse Event data was not collected "per arm" because aFFR and cFFR measurements were made at the same timepoints. Reported AEs include serious adverse events (SAEs) related to the NAVVUS Rxi FFR microcatheter system.
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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 | aFFR vs cFFR | All subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System Iopamidol: aFFR measurement with drug: Iopamidol (ISOVUE®-370). Subjects will receive an injector-based intracoronary bolus of contrast Rate of 4 mL/sec, volume of 10 cc (left coronary system) Rate of 3 mL/sec, volume of 6 cc (right coronary system). adenosine: FFR measurement with drug: adenosine. Intravenous adenosine will be administered at a rate of 140 μg/kg of body weight per minute x 2 minutes Navvus® Catheter: the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing CVi® Contrast Delivery System: The CVi® Contrast Delivery System will be used to deliver the contrast medium |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marjan Cobbaert | Duke Clinical Research Institute | 9196995638 | mr157@duke.edu |
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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 | Mar 23, 2022 | Apr 21, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007479 | Iopamidol |
| D000241 | Adenosine |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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|
| adenosine | Drug | FFR measurement with drug: adenosine. Intravenous adenosine will be administered at a rate of 140 μg/kg of body weight per minute x 2 minutes |
|
|
| Navvus® Catheter | Device | the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing |
|
| CVi® Contrast Delivery System | Device | The CVi® Contrast Delivery System will be used to deliver the contrast medium |
|
| Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | (MACE: death, MI, and TVR) TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. An MI is caused by decreased or complete cessation of blood flow to a portion of the myocardium. | 1 year post procedure |
| Coon Rapids |
| Minnesota |
| 55433 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Durham VA | Durham | North Carolina | 27701 | United States |
| Vanderbilt | Nashville | Tennessee | 37212 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 | aFFR vs cFFR | All subjects will receive Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System Iopamidol: aFFR measurement with drug: Iopamidol (ISOVUE®-370). Subjects will receive an injector-based intracoronary bolus of contrast Rate of 4 mL/sec, volume of 10 cc (left coronary system) Rate of 3 mL/sec, volume of 6 cc (right coronary system). adenosine: FFR measurement with drug: adenosine. Intravenous adenosine will be administered at a rate of 140 μg/kg of body weight per minute x 2 minutes Navvus® Catheter: the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing CVi® Contrast Delivery System: The CVi® Contrast Delivery System will be used to deliver the contrast medium |
|
|
| Primary | Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves | The qualitative method comparison assesses the agreement as to which lesion is flow limiting. The contrast FFR measurement that corresponds to adenosine FFR measurement value of 0.8 will be used as the cutoff value for determining whether a lesion is flow limiting for contrast FFR. Reported as the percentage of agreement between aFFR and cFFR. | All subjects received Fractional Flow Reserve Measurements with both adenosine (aFFR) and contrast (Iopamidol) (cFFR) using the Navvus® Catheter and CVi® Contrast Delivery System. The FFR tracings of 217 lesions from 201 participants were assessed for quality and validity by the Fractional Flow Reserve Core Lab. After qualitative review, 192 FFR pairs were included in the analysis. | Posted | Number | 95% Confidence Interval | proportion of lesions with agreement | Baseline | lesions | lesions |
|
|
|
| Secondary | Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | (MACE: death, MI, and TVR) TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. An MI is caused by decreased or complete cessation of blood flow to a portion of the myocardium. | After quality assessment, 178 patients were included in the analysis | Posted | Number | Events (composite of death, MI, or TVR) | 30 days post procedure |
|
|
|
| Secondary | Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | (MACE: death, MI, and TVR) TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion. An MI is caused by decreased or complete cessation of blood flow to a portion of the myocardium. | After quality assessment, 178 patients were included in the analysis | Posted | Number | Events (composite of death, MI, or TVR) | 1 year post procedure |
|
|
|
| 7 |
| 201 |
| 6 |
| 201 |
| 0 |
| 201 |
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |