Clinical trial NCT02927990: Contrast Volume Reduction During PCI With the Use of a New Assisting Software Package
Official title: Contrast Volume Reduction During Percutaneous Coronary Interventions With the Use of a New Assisting Software Package
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Stenosis
Coronary Occlusion
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2016-10-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Amount [mL] of Contrast Used for Completion of the Coronary Intervention
timeFrame: Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
Secondary outcomes:
measure: Cumulative Dose Area Product (DAP) of Percutaneous Coronary Intervention
timeFrame: DAP [mGycm^2] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
measure: Cumulative Air-Kerma (AK) of Percutaneous Coronary Intervention
timeFrame: AK [mGy] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
measure: Total Fluoroscopy Time of Percutaneous Coronary Intervention
timeFrame: Fluoroscopy time [minutes] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
measure: Procedure Efficiency
timeFrame: 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 outcomes:
measure: Amount of Vessels Treated During Percutaneous Coronary Intervention
timeFrame: Amount [number] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
measure: Quality of Roadmap Images
timeFrame: Quality [score] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
Locations:
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
Study officials:
affiliation: Columbia University Medical Center/NYPH
name: Manish Parikh, MD
role: PRINCIPAL_INVESTIGATOR
References: