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

Terminated

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Study group	Percutaneous Coronary Intervention	Percutaneous coronary interventions with additional imaging provided by the new software package
Control group	Percutaneous Coronary Intervention	Percutaneous coronary interventions without the new software package

Primary Outcome Measures

Name	Time	Method
Amount [mL] of Contrast Used for Completion of the Coronary Intervention	Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.	Phase 2 not initiated Only phase 1 data was collected

Secondary Outcome Measures

Name	Time	Method
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.	No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
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.	No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
Total Fluoroscopy Time of Percutaneous Coronary Intervention	Fluoroscopy time [minutes] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.	No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected
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