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

Coronary Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02927990
• Other study ID #: XCY607-130198
• Status: Completed
• Start date: December 15, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2020
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Coronary Occlusion
• Coronary Stenosis

Intervention

Other:
• Percutaneous Coronary Intervention
Percutaneous Coronary Intervention according to standard of care

Locations

Country	Name	City	State
United States	Columbia University Medical Center/NYPH	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	Quality of Stentboost 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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.