Percutaneous Coronary Intervention
Conditions
Keywords
Fractional Flow Reserve
Brief summary
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: 1. Perform a methods comparison between cFFR and the reference standard aFFR, where cFFR is performed using an automated injector with a standardized volume and rate of delivery of contrast with known osmolality. 2. Evaluate the association between final post-PCI FFR and long-term clinical outcomes. The long-term clinical outcomes will include TVR and composite MACE (death, MI, and TVR) at 30 days and 1 year.
Interventions
DRUGIopamidol
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).
DRUGadenosine
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
DEVICENavvus® Catheter
the NAVVUS RXi microcatheter will be used with a workhorse wire of the operator's choosing
DEVICECVi® Contrast Delivery System
The CVi® Contrast Delivery System will be used to deliver the contrast medium
Sponsors
Acist Medical Systems
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have the capacity to understand and sign an informed consent or have a legally authorized representative (LAR) that can understand and sign an informed consent prior to initial arteriotomy access 2. Age \> 18 years of age at the time of signing the informed consent 3. Clinically stable and undergoing non-emergent cardiac catheterization for appropriate indications 4. Willing to be contacted by telephone at 30 days (if no standard of care visit) and at 1 year with chart review for events. 5. Target vessel with an intermediate lesion of 40-70% stenosis by angiographic assessment (a visual estimation by the operator). Serial lesions, diffuse disease, or ostial lesions (all-comer lesions) are acceptable if the operator would normally perform FFR and proceed with PCI (or other revascularization) if positive.
Exclusion criteria
1. Any condition associated with a life expectancy of less than 1 year 2. Participation in another clinical study using an investigational agent or device within the past 3 months 3. Ejection fraction ≤ 35% 4. Creatinine ≥ 2 5. Severe valvular heart disease 6. Decompensated acute diastolic or systolic heart failure 7. Bronchospastic chronic obstructive pulmonary disease or other intolerance to adenosine 8. ST-segment elevation myocardial infarction culprit lesion or lesions with any thrombus burden after diagnostic angiography 9. Lesions with severe calcification after diagnostic angiography 10. Lesions in a target vessel supplied by a patent graft
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) | Baseline | 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. |
| Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | 30 days post procedure | (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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 201 |
| Total | 201 |
Baseline characteristics
| Characteristic | aFFR vs cFFR |
|---|---|
| Age, Continuous | 67.22 years STANDARD_DEVIATION 8.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 195 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 182 Participants |
| Region of Enrollment United States | 201 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 171 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 201 |
| other Total, other adverse events | 0 / 201 |
| serious Total, serious adverse events | 6 / 201 |
Outcome results
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aFFR vs cFFR | Comparison Between Contrast Fractional Flow Reserves (cFFR) and Adenosine Fractional Flow Reserves (aFFR) | 0.8922 proportion of lesions with agreement |
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.
Time frame: Baseline
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aFFR vs cFFR | Qualitative Method Comparison Between Contrast Fractional Flow Reserves and Adenosine Fractional Flow Reserves | 0.8912 proportion of lesions with agreement |
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.
Time frame: 30 days post procedure
Population: After quality assessment, 178 patients were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aFFR vs cFFR | Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | 3 Events (composite of death, MI, or TVR) |
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.
Time frame: 1 year post procedure
Population: After quality assessment, 178 patients were included in the analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| aFFR vs cFFR | Long-term Clinical Outcomes: Composite Major Adverse Cardiac Events (MACE: Death, MI, and TVR) | 13 Events (composite of death, MI, or TVR) |