Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000333011
Ethics application status
Approved
Date submitted
16/04/2010
Date registered
27/04/2010
Date last updated
17/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Volcano Intravascular Ultrasound (IVUS)-Guided Balloon Evaluation in Patients with Coronary Heart Disease
Scientific title
A Non-Randomized, Non-Blinded, Two Center, Prospective Intravascular Ultrasound (IVUS)-Guided Balloon Feasibility Study in Patients Scheduled for Coronary Intervention.
Secondary ID [1] 251649 0
nil
Universal Trial Number (UTN)
Trial acronym
VIBE NZ
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 257193 0
Condition category
Condition code
Cardiovascular 257337 257337 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256324 0
Treatment: Devices
Comparator / control treatment
There is no control for this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258230 0
Major Adverse Cardiac Events (MACE): Cardiovascular Death, Non Fatal Myocardial Infarction, and Target Vessel Revascularization. These will be assessed by electrocardiogram (ECG) and lab draws for cardiac enzymes.
Timepoint [1] 258230 0
At 30 days post procedure.
Primary outcome [2] 258231 0
Change in minimum lesion diameter by coronary angiography
Timepoint [2] 258231 0
Post balloon dilatation
Primary outcome [3] 258232 0
Repeatability of intravascular ultrasound (IVUS) image measurements pre- and post balloon dilatation, as assessed by a core laboratory.
Timepoint [3] 258232 0
Pre- and post balloon dilatation
Secondary outcome [1] 263899 0
Major Adverse Cardiac Events: Cardiovascular Death, Non Fatal Myocardial Infarction, and Target Vessel Revascularization. These will be assessed by ECG and lab draws for cardiac enzymes.
Timepoint [1] 263899 0
During the procedure, post procedure, and at hospital discharge.

Eligibility
Key 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.
Minimum age
22 Years
Maximum age
84 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2589 0
New Zealand
State/province [1] 2589 0
Auckland

Funding & Sponsors
Funding source category [1] 256826 0
Commercial sector/Industry
Name [1] 256826 0
Volcano Corporation
Country [1] 256826 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Volcano Corporation
Address
3661 Valley Centre Drive, Suite 200
San Diego, California 92130
Country
United States of America
Secondary sponsor category [1] 256103 0
None
Name [1] 256103 0
Address [1] 256103 0
Country [1] 256103 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258843 0
Northern X Regional Ethics Committee
Ethics committee address [1] 258843 0
Ministry of Health
3rd Floor, Unisys Building
650 Great South Road, Penrose
Private Bag 92 522
Wellesley Street, Auckland 1061
Ethics committee country [1] 258843 0
New Zealand
Date submitted for ethics approval [1] 258843 0
21/01/2010
Approval date [1] 258843 0
22/04/2010
Ethics approval number [1] 258843 0
NTX/10/02/008

Summary
Brief summary
To evaluate the safety, balloon performance, and image quality of the Volcano Vascular Imaging Balloon Catheter in patients scheduled for coronary intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31062 0
Address 31062 0
Country 31062 0
Phone 31062 0
Fax 31062 0
Email 31062 0
Contact person for public queries
Name 14309 0
Daniel Redline
Address 14309 0
2870 Kilgore Road
Rancho Cordova, CA 95670
Country 14309 0
United States of America
Phone 14309 0
+1 916-281-2760
Fax 14309 0
Email 14309 0
[email protected]
Contact person for scientific queries
Name 5237 0
Daniel Redline
Address 5237 0
2870 Kilgore Road
Rancho Cordova, CA 95670
Country 5237 0
United States of America
Phone 5237 0
+1 916-281-2760
Fax 5237 0
Email 5237 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.