In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems (SAVOIR2)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Infraredx Test Catheter
Sponsored by
About this trial
This is an interventional screening trial for Coronary Artery Disease
Eligibility Criteria
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)
Sites / Locations
- Royal Adelaide Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Eagle Eye Platinum
Revolution
TVC Insight 40MHz
Atlantis Pro
Arm Description
Eagle Eye Platinum Catheter as the comparator.
Revolution Catheter as the comparator
TVC Insight as comparative catheter.
Atlantis Pro catheter as comparator
Outcomes
Primary Outcome Measures
Clarity of Image and ease of interpretation as measured by physician survey
Secondary Outcome Measures
Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters
Full Information
NCT ID
NCT02154295
First Posted
May 16, 2014
Last Updated
December 10, 2020
Sponsor
Infraredx
Collaborators
South Australian Health and Medical Research Institute, Royal Adelaide Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02154295
Brief Title
In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems
Acronym
SAVOIR2
Official Title
Simultaneous Acquisition of Intravascular Ultrasound and Near Infrared Spectroscopy Data in the Coronary Artery Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infraredx
Collaborators
South Australian Health and Medical Research Institute, Royal Adelaide Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eagle Eye Platinum
Arm Type
Active Comparator
Arm Description
Eagle Eye Platinum Catheter as the comparator.
Arm Title
Revolution
Arm Type
Active Comparator
Arm Description
Revolution Catheter as the comparator
Arm Title
TVC Insight 40MHz
Arm Type
Active Comparator
Arm Description
TVC Insight as comparative catheter.
Arm Title
Atlantis Pro
Arm Type
Active Comparator
Arm Description
Atlantis Pro catheter as comparator
Intervention Type
Device
Intervention Name(s)
Infraredx Test Catheter
Primary Outcome Measure Information:
Title
Clarity of Image and ease of interpretation as measured by physician survey
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Sidharta, MBBS BMedSc
Organizational Affiliation
Royal Adelaide Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
In Vitro and In Vivo Comparison Between Intravascular Ultrasound (IVUS) Systems
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