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Insights and learnings were used to initiate an improved multicenter study.
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The new software package is intended to assist the physician in imaging the coronaries during percutaneous coronary interventions.
This study investigates the amount of contrast used during percutaneous coronary interventions with the aid of the new software package.
The results of the study will be compared with control group data (before the new software package was installed or after it was removed) to define a possible contrast reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Percutaneous coronary interventions with additional imaging provided by the new software package |
| |
| Control group | Percutaneous coronary interventions without the new software package |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Coronary Intervention | Other | Percutaneous Coronary Intervention according to standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount [mL] of Contrast Used for Completion of the Coronary Intervention | Phase 2 not initiated Only phase 1 data was collected | Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Dose Area Product (DAP) of Percutaneous Coronary Intervention | No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected | DAP [mGycm^2] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
| Cumulative Air-Kerma (AK) of Percutaneous Coronary Intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Vessels Treated During Percutaneous Coronary Intervention | Is used as a metric for procedural complexity. | Amount [number] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
| Quality of Roadmap Images |
Inclusion Criteria:
Exclusion Criteria:
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Patients with age 18 or older, of both genders and all races. Patients undergoing a percutaneous coronary intervention. Patients are considered to be enrolled in the study after they have signed the informed consent form.
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| Name | Affiliation | Role |
|---|---|---|
| Manish Parikh, MD | Columbia University Medical Center/NYPH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center/NYPH | New York | New York | 10032 | United States |
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80 subjects are enrolled. Phase 2 not initiated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subject Undergoing PCI Phase 1 | Subject undergoing a percutaneous coronary intervention with navigation support of Dynamic Coronary Roadmap |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Subject Undergoing PCI Phase 1 | Subject undergoing a percutaneous coronary intervention with navigation support of Dynamic Coronary Roadmap |
| 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 | Amount [mL] of Contrast Used for Completion of the Coronary Intervention | 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 | Posted | Median | Standard Deviation | mL | Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
|
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 | PCI Phase 1 | Percutaneous coronary interventions with additional imaging provided by the new software package. Phase 2 not initiated Only phase 1 data was collected. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pim van Lochem | Philips Medical Systems B.V. | +31 (0)634322891 | pim.vanlochem@philips.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 25, 2017 | Sep 12, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| D054059 | Coronary Occlusion |
| 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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No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected |
| AK [mGy] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
| Total Fluoroscopy Time of Percutaneous Coronary Intervention | No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected | Fluoroscopy time [minutes] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
| Procedure Efficiency | The endpoint is procedural timing:
| 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. |
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. |
| Quality [score] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
| No procedure performed, only diagnostic catheterization |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
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| Secondary | Cumulative Dose Area Product (DAP) of Percutaneous Coronary Intervention | 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 | Posted | Median | Standard Deviation | mGy*cm^2 | DAP [mGycm^2] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
|
|
|
| Secondary | Cumulative Air-Kerma (AK) of Percutaneous Coronary Intervention | 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 | Posted | Median | Standard Deviation | mGy | AK [mGy] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
|
|
|
| Secondary | Total Fluoroscopy Time of Percutaneous Coronary Intervention | 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 | Posted | Median | Standard Deviation | minutes | Fluoroscopy time [minutes] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
|
|
|
| Secondary | Procedure Efficiency | The endpoint is procedural timing:
| No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected | Posted | Median | Standard Deviation | minutes | 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. |
|
|
|
| Other Pre-specified | Amount of Vessels Treated During Percutaneous Coronary Intervention | Is used as a metric for procedural complexity. | No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected | Posted | Amount [number] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
|
|
| Other Pre-specified | Quality of Roadmap Images | 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. | No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected | Posted | Quality [score] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up. |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| D014652 |
| Vascular Diseases |
| D019060 | Minimally Invasive Surgical Procedures |
| The time from start of the procedure until first stent is placed |
|
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