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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic Coronary Roadmap group | Experimental | Patients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) with navigation support of Dynamic Coronary Roadmap. |
|
| Control group | Active Comparator | Patients will be treated via standard of care for Percutaneous Coronary Intervention (PCI) without navigation support of Dynamic Coronary Roadmap. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap | Device | Standard of care Percutaneous Coronary Intervention (PCI) with Dynamic Coronary Roadmap |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During Percutaneous Coronary Intervention (PCI) procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier Escaned, MD | San Carlos Hospital Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Denver | Colorado | 80045 | United States | ||
| Columbia University Medical Center/NYPH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38343370 | Derived | Hennessey B, Danenberg H, De Vroey F, Kirtane AJ, Parikh M, Karmpaliotis D, Messenger JC, Strobel A, Curcio A, van Mourik MS, Eshuis P, Escaned J. Dynamic Coronary Roadmap versus standard angiography for percutaneous coronary intervention: the randomised, multicentre DCR4Contrast trial. EuroIntervention. 2024 Feb 5;20(3):e198-e206. doi: 10.4244/EIJ-D-23-00460. | |
| 37040861 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dynamic Coronary Roadmap Group | Patients will be treated via standard of care for PCI (Percutaneous Coronary Intervention) with navigation support of Dynamic Coronary Roadmap. PCI (Percutaneous Coronary Intervention) with Dynamic Coronary Roadmap: Standard of care PCI (Percutaneous Coronary Intervention) with Dynamic Coronary Roadmap |
| FG001 | Control Group | Patients will be treated via standard of care for PCI (Percutaneous Coronary Intervention) without navigation support of Dynamic Coronary Roadmap. PCI (Percutaneous Coronary Intervention) without Dynamic Coronary Roadmap: Standard of care PCI (Percutaneous Coronary Intervention) without Dynamic Coronary Roadmap |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Group |
| 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 | 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). | 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. | Posted | Mean | Standard Deviation | ml | During Percutaneous Coronary Intervention (PCI) procedure |
|
Patients were followed-up until discharge through study completion, which was 1 day on average.
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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 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | Non-systematic Assessment | All Acute Myocardial Infarctions occurred pre study PCI procedure (i.e. unrelated to study participation). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Eshuis | Philips Medical Systems Nederland B.V. | +31628739280 | peter.g.eshuis@philips.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2019 | Nov 16, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 12, 2023 | Nov 16, 2023 | SAP_001.pdf |
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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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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap | Device | Standard of care Percutaneous Coronary Intervention (PCI) without Dynamic Coronary Roadmap |
|
| During Percutaneous Coronary Intervention (PCI) procedure |
| New York |
| New York |
| 10032 |
| United States |
| Grand Hôpital de Charleroi Saint-Joseph | Charleroi | 6060 | Belgium |
| Hadassah Medical Center | Jerusalem | Israel |
| San Carlos Hospital | Madrid | 28040 | Spain |
| Fuenlabrada University Hospital | Madrid | Spain |
| Hennessey B, Messenger JC, Kirtane AJ, Parikh M, Danenberg H, De Vroey F, Curcio A, Eshuis P, Escaned J. Rationale and design of the Dynamic Coronary Roadmap for Contrast Reduction (DCR4Contrast) in PCI randomized controlled trial. Am Heart J. 2023 Sep;263:151-158. doi: 10.1016/j.ahj.2023.04.004. Epub 2023 Apr 9. |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Hypertension (> 140/90 mmHg) | Count of Participants | Participants |
|
| Chronic Kidney Disease | Count of Participants | Participants |
|
| Prior revascularization | Count of Participants | Participants |
|
| Coronary Artery Bypass Graft | Count of Participants | Participants |
|
| Prior Myocardial Infarction | Count of Participants | Participants |
|
| Severe Left ventricular ejection fraction (<30%) | Count of Participants | Participants |
|
| eGFR, ml/min/1.73m^2 | Mean | Standard Deviation | ml/min/1.73m^2 |
|
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
| OG001 | 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 |
|
|
| 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). | 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. | Posted | Mean | Standard Deviation | Number of runs | During Percutaneous Coronary Intervention (PCI) procedure |
|
|
|
| 1 |
| 179 |
| 14 |
| 179 |
| 0 |
| 179 |
| EG001 | 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 | 0 | 177 | 7 | 177 | 0 | 177 |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |