Trial Outcomes & Findings for Contrast Volume Reduction During PCI With the Use of a New Assisting Software Package (NCT NCT02927990)
NCT ID: NCT02927990
Last Updated: 2024-12-06
Results Overview
Phase 2 not initiated Only phase 1 data was collected
TERMINATED
80 participants
Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
2024-12-06
Participant Flow
80 subjects are enrolled. Phase 2 not initiated.
Participant milestones
| Measure |
Subject Undergoing PCI Phase 1
Subject undergoing a percutaneous coronary intervention with navigation support of Dynamic Coronary Roadmap
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
56
|
Reasons for withdrawal
| Measure |
Subject Undergoing PCI Phase 1
Subject undergoing a percutaneous coronary intervention with navigation support of Dynamic Coronary Roadmap
|
|---|---|
|
Overall Study
Protocol Violation
|
4
|
|
Overall Study
Physician Decision
|
9
|
|
Overall Study
Room switched and therefore no study device available
|
15
|
|
Overall Study
No procedure performed, only diagnostic catheterization
|
28
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Subject Undergoing PCI Phase 1
n=24 Participants
Subject undergoing a percutaneous coronary intervention with navigation support of Dynamic Coronary Roadmap
|
|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 6.4 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
|
BMI
|
27.8 kg/m^2
STANDARD_DEVIATION 3.9 • n=24 Participants
|
PRIMARY outcome
Timeframe: Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.Population: No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
Phase 2 not initiated Only phase 1 data was collected
Outcome measures
| Measure |
PCI Phase 1
n=23 Participants
Phase 1 subject undergoing a percutaneous coronary intervention with navigation support of Dynamic Coronary Roadmap
|
PCI Phase 2
Not initiated.
|
|---|---|---|
|
Amount [mL] of Contrast Used for Completion of the Coronary Intervention
|
210 mL
Standard Deviation 108.77
|
—
|
SECONDARY outcome
Timeframe: DAP [mGycm^2] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.Population: No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
Outcome measures
| Measure |
PCI Phase 1
n=22 Participants
Phase 1 subject undergoing a percutaneous coronary intervention with navigation support of Dynamic Coronary Roadmap
|
PCI Phase 2
Not initiated.
|
|---|---|---|
|
Cumulative Dose Area Product (DAP) of Percutaneous Coronary Intervention
|
116409 mGy*cm^2
Standard Deviation 118360
|
—
|
SECONDARY outcome
Timeframe: AK [mGy] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.Population: No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
Outcome measures
| Measure |
PCI Phase 1
n=24 Participants
Phase 1 subject undergoing a percutaneous coronary intervention with navigation support of Dynamic Coronary Roadmap
|
PCI Phase 2
Not initiated.
|
|---|---|---|
|
Cumulative Air-Kerma (AK) of Percutaneous Coronary Intervention
|
1154 mGy
Standard Deviation 1022
|
—
|
SECONDARY outcome
Timeframe: Fluoroscopy time [minutes] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.Population: No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
Outcome measures
| Measure |
PCI Phase 1
n=24 Participants
Phase 1 subject undergoing a percutaneous coronary intervention with navigation support of Dynamic Coronary Roadmap
|
PCI Phase 2
Not initiated.
|
|---|---|---|
|
Total Fluoroscopy Time of Percutaneous Coronary Intervention
|
22 minutes
Standard Deviation 28.37
|
—
|
SECONDARY outcome
Timeframe: Patients will be followed from start of interventional procedure (vascular access obtained) until end of the procedure (vascular closure), ranging between 30 minutes and a few hours.Population: No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
The endpoint is procedural timing: * time from start of procedure (wire introduced into the coronary) * end of procedure (start of vascular closure) * time until wire placed in distal coronary bed for purpose of intervention * time of first stent placement
Outcome measures
| Measure |
PCI Phase 1
n=24 Participants
Phase 1 subject undergoing a percutaneous coronary intervention with navigation support of Dynamic Coronary Roadmap
|
PCI Phase 2
Not initiated.
|
|---|---|---|
|
Procedure Efficiency
The time from start of the procedure until end of the procedure
|
46.5 minutes
Standard Deviation 49.71
|
—
|
|
Procedure Efficiency
The time from start of the procedure until first stent is placed
|
24 minutes
Standard Deviation 19.79
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Amount [number] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.Population: No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
Is used as a metric for procedural complexity.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Quality [score] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.Population: No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
The operating physician is asked after the procedure to indicate what the quality and clinical usefulness of those images by scoring on a 5-point rating scale.
Outcome measures
Outcome data not reported
Adverse Events
PCI Phase 1
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place