None listed
Conditions
Brief summary
To evaluate the safety, balloon performance, and image quality of the Volcano Vascular Imaging Balloon Catheter in patients scheduled for coronary intervention.
Interventions
The Volcano Vascular Imaging Balloon Catheter is used for imaging and/or dilatation of native and/or stented coronary arteries. The catheter is administered through a guide catheter during a percutaneous coronary intervention (PCI) procedure in a cath lab, and is expected to be in the body for less than 10 minutes.
Sponsors
Volcano Corporation
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
22 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
-Patient must be >21 and < 85 years of age. -Patient or patient’s legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by Human Research Ethics Committee (HREC) of the respective investigational site. -Patient has single or multi-vessel disease and is scheduled for coronary intervention.
Exclusion criteria
-Currently participating in an investigational drug or another device trial that has not completed the primary endpoint or that clinically interferes with the current trial endpoints; or requires coronary angiography, IVUS or other coronary artery imaging procedures. -Any patient scheduled to have a percutaneous or surgical coronary intervention within 30 days of the index procedure using the Volcano Vascular Imaging Balloon Catheter. -Any complications due to stenting prior to imaging or dilatation with the Volcano Vascular Imaging Balloon Catheter. -Any contraindications for IVUS interrogation as determined by the investigator. -A Q-wave or non–Q-wave myocardial infarction (MI) within 72 hours of the procedure, with an initial creatine kinase (CK) level of more than twice the upper limit of normal and CK and creatine kinase–myocardial band isoenzyme (CK-MB) fraction persistently abnormal at the time of the procedure. -More than 50% unprotected left main coronary stenosis or more than 50% stenosis of additional lesions proximal or distal to the target lesion either by visual assessment or by Quantitative Coronary Angiography (QCA). -Clinical cardiac failure as defined by New York Heart Association (NYHA) class III or IV. -American College of Cardiology (ACC)/ American Heart Association (AHA) lesion Type C. -Braunwald classification of unstable angina A III. -Ostial lesions. -Total occlusions. -Any target lesion containing severe calcification that precludes successful predilatation. -Severe vessel tortuosity or any angiographic evidence of thrombus. -Left Ventricular Ejection Fraction (LVEF) of less than 30% at the most recent evaluation. -Subjects unwilling or unable to comply with the protocol.
Outcome results
None listed