Simultaneous Acquisition of Intravascular Ultrasound and Near Infrared Spectroscopy Data in the Coronary Artery Study

Infraredx1 site in 1 country16 target enrollmentMay 2014

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Infraredx
Enrollment: 16
Locations: 1
Primary Endpoint: Clarity of Image and ease of interpretation as measured by physician survey
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate and compare the images obtained from coronary imaging catheters used in the treatment of coronary blockages both in a clinical setting with patients and in models.

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

August 2014

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Infraredx

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥18 years of age
•Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
•Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized \[total hysterectomy, bilateral tubal ligation, bilateral oophorectomy\]).
•Target artery must be \>2 mm to accommodate the IVUS catheter.
•IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)

Exclusion Criteria

•Cardiogenic shock
•Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
•Known coronary artery spasm
•Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
•Bleeding diathesis
•Significant renal impairment (patients will be excluded if their calculated creatinine clearance is \< 30 mL/min)