In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
- Target artery must be >2 mm to accommodate the IVUS catheter.
- ≥18 years of age
- ...
- Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
- Target artery must be >2 mm to accommodate the IVUS catheter.
- ≥18 years of age
- Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).
- IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)
Exclusion Criteria
- Bleeding diathesis
- Known coronary artery spasm
- Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
- ...
- Bleeding diathesis
- Known coronary artery spasm
- Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
- Cardiogenic shock
- Significant renal impairment (patients will be excluded if their calculated creatinine clearance is < 30 mL/min)
- Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
Summary
- Conditions
- Coronary (Artery) Disease
- Coronary Artery Disease
- Type
- Interventional
- Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
- Target artery must be >2 mm to accommodate the IVUS catheter.
- ≥18 years of age
- ...
- Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
- Target artery must be >2 mm to accommodate the IVUS catheter.
- ≥18 years of age
- Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).
- IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)
Exclusion Criteria
- Bleeding diathesis
- Known coronary artery spasm
- Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
- ...
- Bleeding diathesis
- Known coronary artery spasm
- Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
- Cardiogenic shock
- Significant renal impairment (patients will be excluded if their calculated creatinine clearance is < 30 mL/min)
- Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
Tracking Information
- NCT #
- NCT02154295
- Collaborators
- South Australian Health and Medical Research Institute
- Royal Adelaide Hospital
- Investigators
- Principal Investigator: Samuel Sidharta, MBBS BMedSc Royal Adelaide Hospital
- Samuel Sidharta, MBBS BMedSc Royal Adelaide Hospital
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