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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02927990

Enrollment

Registered

2016-10-07

Start date

2017-12-15

Completion date

2019-06-30

Last updated

2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Occlusion, Coronary Stenosis

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.

Interventions

OTHERPercutaneous Coronary Intervention

Percutaneous Coronary Intervention according to standard of care

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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
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

Other

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

Countries

United States

Participant flow

Recruitment details

80 subjects are enrolled. Phase 2 not initiated.

Participants by arm

Arm	Count
Subject Undergoing PCI Phase 1 Subject undergoing a percutaneous coronary intervention with navigation support of Dynamic Coronary Roadmap	24
Total	24

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	No procedure performed, only diagnostic catheterization	28
Overall Study	Physician Decision	9
Overall Study	Protocol Violation	4
Overall Study	Room switched and therefore no study device available	15

Baseline characteristics

Characteristic	Subject Undergoing PCI Phase 1	—
Age, Continuous	67.9 years STANDARD_DEVIATION 6.4	—
BMI	27.8 kg/m^2 STANDARD_DEVIATION 3.9	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	24 participants	—
Sex: Female, Male Female	5 Participants	—
Sex: Female, Male Male	19 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 24
other Total, other adverse events	0 / 24
serious Total, serious adverse events	0 / 24

Outcome results

Primary

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.