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

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

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 Overview

• Status: Terminated
• Conditions: Coronary Occlusion; Coronary Stenosis
• Intervention / Treatment: Other: Percutaneous Coronary Intervention

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount [mL] of Contrast Used for Completion of the Coronary Intervention	Phase 2 not initiated Only phase 1 data was collected	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	No data gathered for the primary outcome. Phase 2 not initiated Only phase 1 data was collected	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	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	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Vessels Treated During Percutaneous Coronary Intervention	Is used as a metric for procedural complexity.	Amount [number] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.
Quality of Roadmap Images	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 [score] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global
• Investigators: Principal Investigator: Manish Parikh, MD, Columbia University Medical Center/NYPH

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2017
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: September 23, 2016
• First Submitted That Met QC Criteria: October 5, 2016
• First Posted (Estimated): October 7, 2016

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Coronary Stenosis; Coronary Occlusion
• Other Study ID Numbers: XCY607-130198