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

Philips Clinical & Medical Affairs Global80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Stenosis Coronary Occlusion

Interventions

Percutaneous Coronary InterventionOTHER

Percutaneous Coronary Intervention according to standard of care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Columbia University Medical Center/NYPH

New York, New York, United States

Outcomes

Primary Outcomes

Amount [mL] of Contrast Used for Completion of the Coronary Intervention

Phase 2 not initiated Only phase 1 data was collected

Time frame: Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.

Secondary Outcomes

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

Time frame: 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

No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected

Time frame: 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

Time frame: 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: * 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

Time frame: 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.

Data from ClinicalTrials.gov

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