In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems
Not Applicable
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT02154295
- Lead Sponsor
- Infraredx
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clarity of Image and ease of interpretation as measured by physician survey Day 0
- Secondary Outcome Measures
Name Time Method Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters Day 0
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which IVUS and NIRS technologies detect coronary artery disease in vivo and in vitro?
How does the combination of IVUS and NIRS improve diagnostic accuracy compared to standard-of-care angiography in coronary artery disease?
Which biomarkers are most predictive of response to IVUS-guided interventions in patients with complex coronary lesions?
What adverse events are associated with IVUS and NIRS imaging catheters in coronary artery disease trials, and how are they managed?
How do Infraredx's IVUS/NIRS systems compare to other coronary imaging technologies like OCT in terms of lesion characterization and clinical outcomes?
Trial Locations
- Locations (1)
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Royal Adelaide Hospital🇦🇺Adelaide, South Australia, Australia