Trial Outcomes & Findings for Dynamic Coronary Roadmap for Contrast Reduction (NCT NCT04085614)
NCT ID: NCT04085614
Last Updated: 2024-01-08
Results Overview
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).
COMPLETED
NA
371 participants
During Percutaneous Coronary Intervention (PCI) procedure
2024-01-08
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
188
|
183
|
|
Overall Study
COMPLETED
|
179
|
177
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Protocol Violation
|
9
|
6
|
Baseline Characteristics
Dynamic Coronary Roadmap for Contrast Reduction
Baseline characteristics by cohort
| Measure |
Dynamic Coronary Roadmap Group
n=179 Participants
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
|
Control Group
n=177 Participants
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
|
Total
n=356 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
65.9 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
65.9 years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
282 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Self-reported Race · Black or African American
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Self-reported Race · Non-Black/Non-African American
|
113 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
220 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Self-reported Race · Unknown
|
63 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
127 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
47 participants
n=99 Participants
|
47 participants
n=107 Participants
|
94 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=99 Participants
|
57 participants
n=107 Participants
|
120 participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
46 participants
n=99 Participants
|
47 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
23 participants
n=99 Participants
|
26 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
Weight (kg)
|
85.1 kg
STANDARD_DEVIATION 20.0 • n=99 Participants
|
83.1 kg
STANDARD_DEVIATION 15.6 • n=107 Participants
|
84.1 kg
STANDARD_DEVIATION 18.0 • n=206 Participants
|
|
BMI (kg/m^2)
|
28.9 kg/m^2
STANDARD_DEVIATION 5.7 • n=99 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 4.8 • n=107 Participants
|
28.7 kg/m^2
STANDARD_DEVIATION 5.2 • n=206 Participants
|
|
Diabetes Mellitus
|
66 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
|
Hypertension (> 140/90 mmHg)
|
135 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
259 Participants
n=206 Participants
|
|
Chronic Kidney Disease
|
18 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Prior revascularization
|
62 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Coronary Artery Bypass Graft
|
12 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Prior Myocardial Infarction
|
55 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Severe Left ventricular ejection fraction (<30%)
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
eGFR, ml/min/1.73m^2
|
77.5 ml/min/1.73m^2
STANDARD_DEVIATION 19.7 • n=99 Participants
|
75.5 ml/min/1.73m^2
STANDARD_DEVIATION 19.9 • n=107 Participants
|
76.5 ml/min/1.73m^2
STANDARD_DEVIATION 19.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: During Percutaneous Coronary Intervention (PCI) procedurePopulation: 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.
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).
Outcome measures
| Measure |
Dynamic Coronary Roadmap Group
n=179 Participants
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
|
Control Group
n=177 Participants
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
|
|---|---|---|
|
Total Percutaneous Coronary Intervention (PCI) Iodinated Contrast Volume
|
64.6 ml
Standard Deviation 44.4
|
90.8 ml
Standard Deviation 55.4
|
SECONDARY outcome
Timeframe: During Percutaneous Coronary Intervention (PCI) procedurePopulation: 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.
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).
Outcome measures
| Measure |
Dynamic Coronary Roadmap Group
n=179 Participants
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
|
Control Group
n=177 Participants
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
|
|---|---|---|
|
Number of Angiograms
|
8.7 Number of runs
Standard Deviation 4.7
|
11.7 Number of runs
Standard Deviation 7.6
|
Adverse Events
Dynamic Coronary Roadmap Group
Control Group
Serious adverse events
| Measure |
Dynamic Coronary Roadmap Group
n=179 participants at risk
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
|
Control Group
n=177 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
7.8%
14/179 • Number of events 14 • Patients were followed-up until discharge through study completion, which was 1 day on average.
|
4.0%
7/177 • Number of events 7 • Patients were followed-up until discharge through study completion, which was 1 day on average.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60