Contrast Volume Reduction During PCI With the Use of a New Assisting Software Package
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Study group Percutaneous coronary interventions with additional imaging provided by the new software package |
Other: Percutaneous Coronary Intervention
Percutaneous Coronary Intervention according to standard of care
|
| Control group Percutaneous coronary interventions without the new software package |
Other: Percutaneous Coronary Intervention
Percutaneous Coronary Intervention according to standard of care
|
Outcome Measures
Primary Outcome Measures
- Amount [mL] of iodenated contrast media administered during Percutaneous Coronary Intervention [Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.]
Secondary Outcome Measures
- Cumulative Dose Area Product (DAP) of Percutaneous Coronary Intervention [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 [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 [Fluoroscopy time [seconds] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.]
- Procedure efficiency [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 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
Other Outcome Measures
- Amount of vessels treated during Percutaneous Coronary Intervention [Amount [number] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.]
Is used as a metric for procedural complexity.
- Quality of Roadmap images [Quality [score] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.]
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 of Stentboost images [Quality [score] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject undergoing a percutaneous coronary intervention.
-
Subject 18 years of age or older, or of legal age to give informed consent per state or national law.
Exclusion Criteria:
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Subject undergoing an emergency treatment
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Primary angioplasty for acute ST segment elevation myocardial infarction.
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Subject with contrast allergies
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Subject with severe kidney disease (e-GFR < 40 by Modification of Diet in Renal Disease (MDRD)/Cockcroft Gault clearance formula and/or upon decision by investigator)
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Subject participates in a potentially confounding drug or device trial during the course of the study.
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Prisoners, people who cannot legally give consent, pregnant women and breastfeeding women.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Columbia University Medical Center/NYPH | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Philips Clinical & Medical Affairs Global
Investigators
- Principal Investigator: Manish Parikh, MD, Columbia University Medical Center/NYPH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XCY607-130198