Coronary Artery Disease
Conditions
Brief summary
The Dynamic Coronary Roadmap is a commercially available product developed by Philips Medical Systems, a Philips Healthcare company. Dynamic Coronary Roadmap is a software medical device intended to provide a real-time and dynamic angiographic roadmap of coronary arteries. The angiographic roadmap is automatically generated from previously acquired coronary angiograms during the same procedure. Dynamic Coronary Roadmap overlays the angiographic roadmap on live 2D fluoroscopic images, thereby assisting the physician in navigating devices, e.g. (guide) wires, catheters, through the coronary arteries. This is a multi-center, prospective, unblinded, stratified 1:1 randomized controlled trial to assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group without Dynamic Coronary Roadmap.
Detailed description
Primary objective: • To assess whether using Dynamic Coronary Roadmap reduces the total iodinated contrast volume related to Percutaneous Coronary Intervention (PCI) compared to the control group without Dynamic Coronary Roadmap. Secondary objective: • To assess the total number of contrast enhanced cine angiographic X-ray runs (angiograms) related to Percutaneous Coronary Intervention (PCI) in the Dynamic Coronary Roadmap and control group
Interventions
DEVICEPercutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap
Standard of care Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap
DEVICEPercutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap
Standard of care Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is undergoing Percutaneous Coronary Intervention (PCI) with a degree of complexity that anticipates the need for more than 25ml of iodinated contrast volume * Subject has signed informed consent * Subject is 18 years of age or older, or of legal age to give informed consent per state or national law
Exclusion criteria
* Subject undergoing emergency Percutaneous Coronary Intervention (PCI) * Subject with ST-segment Elevation Myocardial Infarction (STEMI) * Subject with Chronic Total Occlusion (CTO) * Subject undergoing PCI for isolated ostial disease of Left Main Coronary Artery (LMCA) or Right Coronary Artery (RCA) * Subject undergoing Percutaneous Coronary Intervention (PCI) with Optical Coherence Tomography (OCT) support * Subject undergoing Percutaneous Coronary Intervention (PCI) with rotational or orbital atherectomy * Subject with Chronic Kidney Disease (CKD) stage V (estimated Glomerular Filtration Rate (eGFR) \< 15 ml/min/1.73 m\^2) * Subject with contrast allergy that cannot be adequately pre-medicated * Subject participates in a potentially confounding drug or device trial during the course of the study. * Subject is under 18 years of age, or pregnant woman, or breast feeding woman, or meets an
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume | During Percutaneous Coronary Intervention (PCI) procedure | Average total undiluted contrast volume (in ml, measured by an automatic contrast injector) per Percutaneous Coronary Intervention (PCI), where the start of the PCI is marked by the moment the interventional guiding catheter is positioned in a stable coronary position and the end of the PCI is marked by time of the last PCI check exposure run (angiogram). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Angiograms | During Percutaneous Coronary Intervention (PCI) procedure | Average total number of contrast enhanced cine angiographic X-ray runs (angiograms) per Percutaneous Coronary Intervention (PCI) (from start of PCI marked by the moment the interventional guiding catheter is positioned in a stable coronary position till the end of the PCI marked by the time of the last PCI check exposure run, i.e., angiogram) determined via visual assessment (e.g., on the Philips X-ray system). |
Countries
Belgium, Israel, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dynamic Coronary Roadmap Group Patients will be treated via standard of care for PCI with navigation support of Dynamic Coronary Roadmap.
PCI with Dynamic Coronary Roadmap: Standard of care PCI with Dynamic Coronary Roadmap | 179 |
| Control Group Patients will be treated via standard of care for PCI without navigation support of Dynamic Coronary Roadmap.
PCI without Dynamic Coronary Roadmap: Standard of care PCI without Dynamic Coronary Roadmap | 177 |
| Total | 356 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 9 | 6 |
Baseline characteristics
| Characteristic | Control Group | Dynamic Coronary Roadmap Group | Total |
|---|---|---|---|
| Age, Continuous | 65.9 years STANDARD_DEVIATION 10.9 | 65.8 years STANDARD_DEVIATION 10.8 | 65.9 years STANDARD_DEVIATION 10.9 |
| BMI (kg/m^2) | 28.5 kg/m^2 STANDARD_DEVIATION 4.8 | 28.9 kg/m^2 STANDARD_DEVIATION 5.7 | 28.7 kg/m^2 STANDARD_DEVIATION 5.2 |
| Chronic Kidney Disease | 26 Participants | 18 Participants | 44 Participants |
| Coronary Artery Bypass Graft | 15 Participants | 12 Participants | 27 Participants |
| Diabetes Mellitus | 68 Participants | 66 Participants | 134 Participants |
| eGFR, ml/min/1.73m^2 | 75.5 ml/min/1.73m^2 STANDARD_DEVIATION 19.9 | 77.5 ml/min/1.73m^2 STANDARD_DEVIATION 19.7 | 76.5 ml/min/1.73m^2 STANDARD_DEVIATION 19.8 |
| Hypertension (> 140/90 mmHg) | 124 Participants | 135 Participants | 259 Participants |
| Prior Myocardial Infarction | 54 Participants | 55 Participants | 109 Participants |
| Prior revascularization | 60 Participants | 62 Participants | 122 Participants |
| Race/Ethnicity, Customized Self-reported Race Black or African American | 6 Participants | 3 Participants | 9 Participants |
| Race/Ethnicity, Customized Self-reported Race Non-Black/Non-African American | 107 Participants | 113 Participants | 220 Participants |
| Race/Ethnicity, Customized Self-reported Race Unknown | 64 Participants | 63 Participants | 127 Participants |
| Region of Enrollment Belgium | 47 participants | 47 participants | 94 participants |
| Region of Enrollment Israel | 47 participants | 46 participants | 93 participants |
| Region of Enrollment Spain | 26 participants | 23 participants | 49 participants |
| Region of Enrollment United States | 57 participants | 63 participants | 120 participants |
| Severe Left ventricular ejection fraction (<30%) | 6 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Female | 38 Participants | 36 Participants | 74 Participants |
| Sex: Female, Male Male | 139 Participants | 143 Participants | 282 Participants |
| Weight (kg) | 83.1 kg STANDARD_DEVIATION 15.6 | 85.1 kg STANDARD_DEVIATION 20 | 84.1 kg STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 179 | 0 / 177 |
| other Total, other adverse events | 0 / 179 | 0 / 177 |
| serious Total, serious adverse events | 14 / 179 | 7 / 177 |
Outcome results
Primary
Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume
Average total undiluted contrast volume (in ml, measured by an automatic contrast injector) per Percutaneous Coronary Intervention (PCI), where the start of the PCI is marked by the moment the interventional guiding catheter is positioned in a stable coronary position and the end of the PCI is marked by time of the last PCI check exposure run (angiogram).
Time frame: During Percutaneous Coronary Intervention (PCI) procedure
Population: The Full Analysis Population (FAP) was defined as all randomized subjects who underwent a Percutaneous Coronary Intervention (PCI) in at least one vessel without the use of Optical Coherence Tomography (OCT) and/or rotational or orbital atherectomy of which the primary endpoint and/or the secondary endpoint were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dynamic Coronary Roadmap Group | Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume | 64.6 ml | Standard Deviation 44.4 |
| Control Group | Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume | 90.8 ml | Standard Deviation 55.4 |
Secondary
Number of Angiograms
Average total number of contrast enhanced cine angiographic X-ray runs (angiograms) per Percutaneous Coronary Intervention (PCI) (from start of PCI marked by the moment the interventional guiding catheter is positioned in a stable coronary position till the end of the PCI marked by the time of the last PCI check exposure run, i.e., angiogram) determined via visual assessment (e.g., on the Philips X-ray system).
Time frame: During Percutaneous Coronary Intervention (PCI) procedure
Population: The Full Analysis Population (FAP) was defined as all randomized subjects who underwent a Percutaneous Coronary Intervention (PCI) in at least one vessel without the use of Optical Coherence Tomography (OCT) and/or rotational or orbital atherectomy of which the primary endpoint and/or the secondary endpoint were available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dynamic Coronary Roadmap Group | Number of Angiograms | 8.7 Number of runs | Standard Deviation 4.7 |
| Control Group | Number of Angiograms | 11.7 Number of runs | Standard Deviation 7.6 |