Coronary Artery Disease
Conditions
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.
Interventions
DEVICEInfraredx Test Catheter
Sponsors
South Australian Health and Medical Research Institute
Royal Adelaide Hospital
Infraredx
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clarity of Image and ease of interpretation as measured by physician survey | Day 0 |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters | Day 0 |
Countries
Australia
Outcome results
None listed