Contrast Volume Reduction During PCI With the Use of a New Assisting Software Package

Study Overview
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Brief Summary
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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.

Official Title
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Contrast Volume Reduction During Percutaneous Coronary Interventions With the Use of a New Assisting Software Package

Conditions
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Coronary Stenosis, Coronary Occlusion

Intervention / Treatment
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* Other: Percutaneous Coronary Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: Subject undergoing an emergency treatment Primary angioplasty for acute ST segment elevation myocardial infarction. Subject with contrast allergies 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) Subject participates in a potentially confounding drug or device trial during the course of the study. Prisoners, people who cannot legally give consent, pregnant women and breastfeeding women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Percutaneous coronary interventions with additional imaging provided by the new software package | Other: Percutaneous Coronary Intervention<br>* Percutaneous Coronary Intervention according to standard of care<br>|
| Control group<br>Percutaneous coronary interventions without the new software package | Other: Percutaneous Coronary Intervention<br>* Percutaneous Coronary Intervention according to standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. |